NA 2274-04-000Recalls & reported problems
Depuy (Ireland) · HEXAGON SCREWDRIVER SHAFT RIGID · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This DePuy hexagon screwdriver shaft is a rigid surgical tool used to tighten and loosen bone screws. The 60 reports describe the shaft wearing down with repeated use, bending or deforming, and sometimes breaking, including into two pieces during surgery, which can stop it from locking into the screw. The reports mention no injuries and no deaths. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 60
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 60 adverse event reports that list this exact device (DI 10603295109037), received between Aug 18, 2017 and Jun 27, 2025 — classified as 60 malfunctions.
The most frequently reported specific device problem is “Naturally Worn” (22 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Naturally Worn22
- Material Twisted/Bent16
- Material Deformation13
- Break8
- Appropriate Device Problem Term/Code Not Available7
- Device-Device Incompatibility3
- Dull, Blunt3
- Failure to Cut2
Patient problems
- No Consequences Or Impact To Patient35
- No Clinical Signs, Symptoms or Conditions18
- No Information6
- Not Applicable2
- No Code Available1
Recent adverse event reports
The 25 most recent of 60 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 27, 2025Break; Break
IT WAS REPORTED THAT THE INSTRUMENTS WERE BROKEN. IT DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22350072 ↗MalfunctionAug 28, 2023Break; Device-Device Incompatibility; Break; Device-Device Incompatibility
IT WAS REPORTED THAT THE DRIVER WAS A BROKEN AND WOULD NOT LOCK INTO LINER ACREW. NO OTHER INFORMATION AVAILABLE AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17632201 ↗MalfunctionFeb 6, 2023Naturally Worn; Naturally Worn
IT WAS REPORTED THAT THE TIP OF DRIVER IS WORN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16305295 ↗MalfunctionJan 19, 2023Device-Device Incompatibility; Naturally Worn; Device-Device Incompatibility; Naturally Worn
IT WAS REPORTED THAT THE TIP OF SCREWDRIVER IS STRIPPED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16205926 ↗MalfunctionSep 29, 2022Break; Break
IT WAS REPORTED THE SCREW DRIVER BROKE INTO TWO PIECES DURING SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15501665 ↗MalfunctionAug 18, 2022Naturally Worn; Naturally Worn
IT WAS REPORTED THAT THE SCREWDRIVER IS STRIPPED. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15249655 ↗MalfunctionJun 22, 2022Naturally Worn; Naturally Worn
IT WAS REPORTED THAT THE HEX DRIVER STRIPPED. THERE WAS NO REPORTED SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14776584 ↗MalfunctionFeb 3, 2022Naturally Worn; Naturally Worn
THE STRAIGHT SHAFT SCREW DRIVER TIP APPEARS WORN. IT APPEARS STRIPPED. NO SURGICAL DELAY .
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13446619 ↗MalfunctionSep 27, 2021Naturally Worn; Naturally Worn
ADDITIONAL INFORMATION RECEIVED INDICATED THAT IT WAS THE IMPACTOR THAT WAS WORN AND NOT MAKING ITS FUNCTION AS INTENDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12532731 ↗MalfunctionSep 24, 2021Naturally Worn; Naturally Worn
SCREWDRIVER HEAD HAS WORN PREVENTING IT TO SEAT IN THE SCREW HEAD PROPERLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12525748 ↗MalfunctionJul 23, 2021Material Twisted/Bent; Naturally Worn; Material Twisted/Bent; Naturally Worn
IT WAS REPORTED THAT THE TIP OF THE HEX SCREWDRIVER IS FILED DOWN. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12218594 ↗MalfunctionJul 22, 2021Material Twisted/Bent; Naturally Worn; Material Twisted/Bent; Naturally Worn
IT WAS REPORTED THAT THE HEX SCREWDRIVER IS STRIPPED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12211336 ↗MalfunctionJun 9, 2021Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT DURING SCREW INSERTION TWO RIGID HEX SHAFT DRIVER HEADS WERE STRIPPED. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11968629 ↗MalfunctionMay 14, 2021Material Twisted/Bent; Material Twisted/Bent
SCREWDRIVER ROUNDED OFF, MADE IT DIFFICULT TO USE DURING CASE. NO SURGERY DELAY. DIFFERENT SCREWDRIVER WAS USED TO COMPLETE THE CASE. PROCEDURE SUCCESSFULLY COMPLETED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11826543 ↗MalfunctionApr 29, 2021Break; Material Twisted/Bent; Break; Material Twisted/Bent
ADDITIONAL INFORMATION RECEIVED INDICATED THAT ANOTHER SET WAS ON STANDBY. THE AMOUNT OF TIME IT TOOK TO OPEN A WRAPPED INSTRUMENT AFTER NOTICING THE OTHER WAS FILED DOWN WAS ABOUT 30 SECONDS TO 1 MINUTE . THERE WAS NO IMPACT TO PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11748383 ↗MalfunctionApr 12, 2021Break; Break
IT WAS REPORTED THAT THE 9/10X6 MM SHIM WAS FOUND BROKEN INTO TWO PIECES WHILE CLEANING TRAYS UP. ALL PIECES ARE ACCOUNTED FOR. RIGID HEX DRIVER WAS ALSO FOUND BROKEN. THE TIP WAS SNAPPED OFF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11649132 ↗MalfunctionJan 22, 2021Failure to Cut; Failure to Cut
IT WAS REPORTED THAT BOTH SCREW DRIVERS ARE DULL AND NEED TO BE REPLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11214409 ↗MalfunctionJan 22, 2021Failure to Cut; Failure to Cut
IT WAS REPORTED THAT BOTH SCREW DRIVERS ARE DULL AND NEED TO BE REPLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11214402 ↗MalfunctionSep 29, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2020 VIA THA. DURING THE SURGERY, THE HANDLE (P/N: 227402000) AND THE QUICKSET RATCHET SCDR HDL (P/N: 227408000) DID NOT FIT. THE SURGEON KEPT ON USING THE HANDLE AND THE SCREWDRIVER WITH UNFITNESS TO INSERT SCREWS. INSERTING SCREWS WAS COMPLETED SUCCESSFULLY. THE SURGERY WAS COMPLETED WITHIN 30 MINUTES DELAY. THE SCRDRVR SHAFT RIGID (P/N: 227404000) HAS NO DEFECT AND IT FITTED TO THE HANDLE WITH NO PROBLEM, BUT THE SALES REP WILL SHIP IT TO TEST. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Code Available
MAUDE report 10602883 ↗MalfunctionMay 28, 2020Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT THE SCREWDRIVERS ARE ALL STRIPPED. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10099118 ↗MalfunctionMay 27, 2020Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT THE SCREWDRIVERS WERE STRIPPED AND POLY EXTRACTOR WAS BROKEN. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10093926 ↗MalfunctionFeb 26, 2020Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT THE STRAIGHT HEX SCREW DRIVERS ARE STRIPPED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9758397 ↗MalfunctionFeb 26, 2020Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT THE STRAIGHT HEX SCREW DRIVERS ARE STRIPPED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9758395 ↗MalfunctionOct 25, 2019Material Deformation; Naturally Worn; Material Deformation; Naturally Worn
IT WAS REPORTED THAT THE END OF INSTRUMENT ARE STRIPPED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9240624 ↗MalfunctionOct 25, 2019Material Deformation; Naturally Worn; Material Deformation; Naturally Worn
IT WAS REPORTED THAT THE END OF INSTRUMENT ARE STRIPPED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9240608 ↗
Other SCREWDRIVER devices
- DELTA XTEND 2307-92-003Depuy (Ireland) · SCREWDRIVER751 reports
- EXPEDIUM 279712400Medos International Sàrl · SCREWDRIVER551 reports
- NA 314.467Synthes GmbH · SCREWDRIVER498 reports
- N/A 5584111Medtronic Sofamor Danek, Inc. · SCREWDRIVER492 reports
- QUICKSET 2274-47-000Depuy (Ireland) · SCREWDRIVER487 reports
- NA 03.130.010Synthes GmbH · SCREWDRIVER1 recall422 reports
- QUICKSET 2274-63-000Depuy (Ireland) · SCREWDRIVER404 reports
- EVOS 71175072Smith & Nephew, Inc. · SCREWDRIVER336 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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