Device brand name · Bit drill

1 8mm Drill Bit With Depth Mark/Qc/110mm: medical device reports filed with FDA

186 reports name it, 2013–2026. Manufacturer given most often on reports: Synthes. Product code HTW.

Read first · FDA's statement on these data

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product. openFDA, FDA

FDA adds: "Although MDRs are a valuable source of information, this passive surveillance system has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data. In addition, the incidence or prevalence of an event cannot be determined from this reporting system alone due to potential under-reporting of events and lack of information about frequency of device use." And: "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices."

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

186
device reports naming the brand: 0% of all MAUDE reports · about 14 a year; 10
reports, 12 months to August 2026: 10 in the 12 months before; 88.7%
classified as malfunction: 85.1% across the product code; 0%
classified as death, as reported: 0 reports · not verified by FDA

186 medical device reports received by FDA name the brand "1 8mm Drill Bit With Depth Mark/Qc/110mm" (bit drill); the manufacturer given most often on reports is Synthes; received from February 2013 to August 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.

10 reports arrived in the 12 months to August 2026, close to the 10 of the 12 months before. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases. The event types recorded are malfunction (88.7%) and injury (11.3%); across all bit, drill reports (product code HTW) death is recorded in 0% and malfunction in 85.1%. Event type is the reporter's classification of the report, not a verified outcome.

The device problems coded most often are break (60.8%), device operates differently than expected (10.2%) and failure to cut (7%). The patient problems coded most often are no patient involvement, foreign body in patient and device embedded in tissue or plaque. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."

Reports by month, five years

Reports by the month FDA received them. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.

By year received

Event type and report source

Event type, as classified on the report

Death0%0

Injury11.3%21

Malfunction88.7%165

Other0%0

Not given0%0

Who filed the report

Manufacturer report99.5%185

Voluntary report0%0

User facility report0%0

Distributor report0%0

Not given0.5%1

Grey bar: all 17,868 reports carrying product code HTW. Event type is the filer's classification and is not verified by FDA.

Device problems coded

Device problem (FDA code)	Reports	Share	Share across product code
Breakthe device broke	113	60.8%	58.1%
Device operates differently than expectedthe device behaved unexpectedly	19	10.2%	1%
Failure to cut	13	7%	7%
Entrapment of device	10	5.4%	5.9%
Device-device incompatibility	5	2.7%	4.4%
Material deformation	1	0.5%	4.5%
Material fragmentation	1	0.5%	2.1%

FDA's device problem codes as entered on the report; one report can carry several. Generic codes such as "no apparent adverse event" are left out.

Patient problems coded

Patient problem (FDA code)	Reports	Share
No patient involvement	26	14%
Foreign body in patientpart of a device left in the patient	11	5.9%
Device embedded in tissue or plaque	4	2.2%

Patient problem codes are present mainly in reports filed since 2019 and are often blank.

In context

Measure	1 8mm Drill Bit With Depth Mark/Qc/110mm	Product code HTW	All MAUDE reports
Reports	186	17,868	26,136,888
Share of that pool	—	1%	0%
Classified as death, per 1,000 reports	0	0	9
Classified as injury	11.3%	13.5%	36.2%
Classified as malfunction	88.7%	85.1%	62.3%
Filed by the manufacturer	99.5%	94.2%	94.9%

Shares are of reports, not of devices in use. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."

Other brands with product code HTW

Brand	Reports	Latest 12 months	Classified as death
Quickset 1pc Flex Drill Bit 25	2,287	158	0%
Quickset 1pc Flex Drill Bit 35	991	38	0%
Quickset 1pc Flex Drill Bit 30	951	49	0%
2 0mm Drill Bit With Depth Mark/Qc/140mm	360	19	0%
6mm/9mm Cannulated Stepped Drill Bit	328	23	0%
Quickset	525	520	0%
UNK - Drill Bits: Trauma	285	14	0%
4 2mm Three-Fluted Drill Bit Qc/Needle Point/145mm	228	44	0%
Quickset 1pc Flex Drill Bit 45	263	11	0%
45 Deg Angle Drill	212	11	0%
3 2mm Three-Fluted Drill Bit Qc/Needle Point/145mm	198	23	0%
3 8mm Drill Bit 25mm	184	14	0%
2 8mm Drill Bit/Qc/165mm	166	8	0%
1 1mm Drill Bit/Mqc For Threaded Hole/56mm	164	20	0%
Pin Rev Dome Drill 25mm	172	11	0%

Ordered by report count for navigation only. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data." FDA also states that "common products may have a higher number of adverse events due to the higher total number of people using the product."

Questions about 1 8mm Drill Bit With Depth Mark/Qc/110mm reports

How many FDA reports name 1 8mm Drill Bit With Depth Mark/Qc/110mm?

186 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 10 in the latest 12 months.

What kinds of events are reported?

malfunction (88.7%) and injury (11.3%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.

What device problems are coded?

break (60.8%), device operates differently than expected (10.2%), failure to cut (7%), entrapment of device (5.4%) and device-device incompatibility (2.7%). These are FDA's device problem codes as entered on the report.

Who files these reports?

manufacturer reports (99.5%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.

Do these reports show that 1 8mm Drill Bit With Depth Mark/Qc/110mm was at fault?

No. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data." FDA adds that "a causal relationship cannot be established between product and reactions listed in a report."

How do I report a problem with a medical device?

Through FDA MedWatch (Form FDA 3500 for health professionals and consumers), or to the manufacturer. See the guide on how to report.

Where this comes from. Counts are built from the openFDA Device Adverse Event (MAUDE) bulk export released 28 Sep 2026, which holds reports FDA received through 31 Aug 2026. Brand, generic and manufacturer names are as written on the reports; product code names come from FDA's device classification. A report counts here when any device it lists carries this brand name after punctuation and capitalisation are normalised. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.

Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.