Tear Drop Guide Wire 3 0 Mm Diameter 100 Cm Length: medical device reports filed with FDA

173 reports name it, 2018–2019. Manufacturer given most often on reports: Zimmer Biomet. Product code HSB.

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.

173
device reports naming the brand: 0% of all MAUDE reports · about 21 a year; 0
reports, 12 months to August 2026: 0 in the 12 months before; 99.4%
classified as malfunction: 33% across the product code; 0%
classified as death, as reported: 0 reports · not verified by FDA

173 medical device reports received by FDA name the brand "Tear Drop Guide Wire 3 0 Mm Diameter 100 Cm Length" (rod fixation); the manufacturer given most often on reports is Zimmer Biomet; received from May 2018 to July 2019. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.

0 reports arrived in the 12 months to August 2026, and none in 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 (99.4%) and injury (0.6%); across all rod, fixation, intramedullary and accessories reports (product code HSB) death is recorded in 0.3% and malfunction in 33%. Event type is the reporter's classification of the report, not a verified outcome.

The device problems coded most often are delivered as unsterile product (44.5%), packaging problem (33.5%) and dent in material (9.2%). The patient problems coded most often are no patient involvement. 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

No report naming Tear Drop Guide Wire 3 0 Mm Diameter 100 Cm Length was received in the five years to August 2026; the latest was received in July 2019.

Event type and report source

Event type, as classified on the report

Death0%0

Injury0.6%1

Malfunction99.4%172

Other0%0

Not given0%0

Who filed the report

Manufacturer report100%173

Voluntary report0%0

User facility report0%0

Distributor report0%0

Not given0%0

Grey bar: all 37,835 reports carrying product code HSB. 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
Delivered as unsterile product	77	44.5%	0.5%
Packaging problem	58	33.5%	0.8%
Dent in material	16	9.2%	0%
Contamination /decontamination problem	10	5.8%	0.2%
Material integrity problema problem with the device material	5	2.9%	0.3%
Material discolored	4	2.3%	0.3%
Device packaging compromised	3	1.7%	0.3%
Material deformation	3	1.7%	1.1%
Tear, rip or hole in device packaging	1	0.6%	0.2%

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	144	83.2%

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

In context

Measure	Tear Drop Guide Wire 3 0 Mm Diameter 100 Cm Length	Product code HSB	All MAUDE reports
Reports	173	37,835	26,136,888
Share of that pool	—	0.5%	0%
Classified as death, per 1,000 reports	0	3	9
Classified as injury	0.6%	66.3%	36.2%
Classified as malfunction	99.4%	33%	62.3%
Filed by the manufacturer	100%	98.9%	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 HSB

Brand	Reports	Latest 12 months	Classified as death
Sign Im Nail	2,301	226	0%
UNK - Nails: TFNA	412	24	0%
Trochanteric Nail Kit Ti Gamma3 11x180mm X 125	366	0	0.3%
Unknown T2 Scn	355	0	0%
SIGN Fin NAIL	335	50	0%
UNK - Nail Head Elements: TFNA Helical Blade	270	13	0%
Unk - Nail Head Elements Pfna Blade	260	1	0%
Radiolucent Insertion Handle Frn	256	14	0%
Helical Blade/Screw Coupling Screw	226	41	0%
Precice Stryde System	226	0	0%
Lag Screw Driver	223	14	0%
Unknown T2 Tibia Nail	223	0	0%
Cannulated Connecting Screw	206	27	0%
Target Device Gamma3 300x160mm	239	1	0%
Unknown T2 Alpha Tibia Nail	199	175	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 Tear Drop Guide Wire 3 0 Mm Diameter 100 Cm Length reports

How many FDA reports name Tear Drop Guide Wire 3 0 Mm Diameter 100 Cm Length?

173 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 0 in the latest 12 months.

What kinds of events are reported?

malfunction (99.4%) and injury (0.6%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.

What device problems are coded?

delivered as unsterile product (44.5%), packaging problem (33.5%), dent in material (9.2%), contamination /decontamination problem (5.8%) and material integrity problem (2.9%). These are FDA's device problem codes as entered on the report.

Who files these reports?

manufacturer reports (100%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.

Do these reports show that Tear Drop Guide Wire 3 0 Mm Diameter 100 Cm Length 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.