Reported Reactions

Devices › Drills, burrs, trephines & accessories (simple, powered)

Device brand name · Drills burrs trephines & accessories - compact speed reducer

Perforator Driver W/Hudson End: medical device reports filed with FDA

695 reports name it, 2013–2017. Manufacturer given most often on reports: Depuy Synthes Power Tools. Product code HBE.

695
device reports naming the brand
0% of all MAUDE reports · about 52 a year
0
reports, 12 months to August 2026
0 in the 12 months before
99%
classified as malfunction
96.7% across the product code
0%
classified as death, as reported
0 reports · not verified by FDA

695 medical device reports received by FDA name the brand "Perforator Driver W/Hudson End" (drills burrs trephines & accessories - compact speed reducer); the manufacturer given most often on reports is Depuy Synthes Power Tools; received from March 2013 to November 2017. 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%) and injury (0.9%); across all drills, burrs, trephines & accessories (simple, powered) reports (product code HBE) death is recorded in 0% and malfunction in 96.7%. Event type is the reporter's classification of the report, not a verified outcome.

The device problems coded most often are bent (26.6%), device operates differently than expected (14.8%) and break (13.5%). The patient problems coded most often are no patient involvement, injury and expulsion. 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 Perforator Driver W/Hudson End was received in the five years to August 2026; the latest was received in November 2017.

By year received

02324632013: 46320132014: 7920142015: 6520152016: 4920162017: 392017

Event type and report source

Event type, as classified on the report

Death0%0
Injury0.9%6
Malfunction99%688
Other0%0
Not given0.1%1

Who filed the report

Manufacturer report100%695
Voluntary report0%0
User facility report0%0
Distributor report0%0
Not given0%0

Grey bar: all 22,777 reports carrying product code HBE. Event type is the filer's classification and is not verified by FDA.

Device problems coded

Device problem (FDA code)ReportsShareShare across product code
Bent18526.6%1.3%
Device operates differently than expectedthe device behaved unexpectedly10314.8%1.7%
Breakthe device broke9413.5%9%
Device inoperablethe device could not be used8412.1%0.8%
Mechanical problema mechanical problem426%0.7%
Overheating of device385.5%26.9%
Sticking365.2%0.6%
Vibration253.6%3.5%
Temperature problem172.4%1.6%
Application interface becomes non-functional or program exits abnormally162.3%0.1%
Noise, audible152.2%1.6%
Positioning problem121.7%0.1%
Detachment of device component71%1%
Device displays incorrect message71%1.3%
Device maintenance issue71%0.1%
Component missing50.7%0.2%
Unintended movement50.7%0.2%
Corrodedthe device corroded40.6%0.5%
Difficult to insertthe device was hard to insert40.6%3.2%
Defective component30.4%0.1%

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)ReportsShare
No patient involvement9413.5%
Injurya physical injury20.3%
Expulsion10.1%
Laceration(s)10.1%
Thrombosis10.1%
Tissue damage10.1%

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

In context

MeasurePerforator Driver W/Hudson EndProduct code HBEAll MAUDE reports
Reports69522,77726,136,888
Share of that pool—3.1%0%
Classified as death, per 1,000 reports009
Classified as injury0.9%3.1%36.2%
Classified as malfunction99%96.7%62.3%
Filed by the manufacturer100%99%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 HBE

BrandReportsLatest 12 monthsClassified as death
Midas Rex MR87,2626,4160%
Unknown_InstrumentstIre_Product1,4751230%
Micro Sagittal Saw1,39500%
Ipc Handpiece - Indigo Drill727790%
Minimal Access Attachment49810%
Motor Legend Ehs Stylus41770%
Ipc Handpiece Attachment - Indigo Drill391320%
Midas Rex Legend9523560%
Ipc Handpiece - Stylus Touch28560%
Ipc Handpiece - Powerease Driver2601540%
Footed Attachment 16mm256180%
Compact Speed Reducer 60 132500%
Elite 12cm Straight Attachment236120%
Emax 2 Plus Motor8,860620%
Core Micro Drill67000%

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 Perforator Driver W/Hudson End reports

How many FDA reports name Perforator Driver W/Hudson End?

695 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%) and injury (0.9%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.

What device problems are coded?

bent (26.6%), device operates differently than expected (14.8%), break (13.5%), device inoperable (12.1%) and mechanical problem (6%). 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 Perforator Driver W/Hudson End 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.