NA 2274-08-000Recalls & reported problems
Depuy (Ireland) · HEXAGON SCREWDRIVER SHAFT CARDAN · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This DePuy Hexagon screwdriver shaft is a surgical instrument used to tighten screws during hip and other orthopedic procedures. Most of the 55 reports describe the tool breaking during surgery, with the tip snapping off so pieces had to be retrieved, and some mention it would not fit or work with other instruments. No deaths and no injuries are reported. There are no recalls naming this device, and reporting has been fairly steady in recent years.
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
- 55
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 55 adverse event reports that list this exact device (DI 10603295109051), received between Jul 20, 2017 and Feb 9, 2026 — classified as 55 malfunctions.
The most frequently reported specific device problem is “Break” (31 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
- Break31
- Device-Device Incompatibility14
- Material Deformation5
- Material Twisted/Bent4
- Entrapment of Device2
- Failure to Cut1
- Naturally Worn1
- No Apparent Adverse Event1
Patient problems
- No Clinical Signs, Symptoms or Conditions27
- No Consequences Or Impact To Patient22
- Insufficient Information3
- No Code Available3
- Not Applicable3
- No Information1
Recent adverse event reports
The 25 most recent of 55 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 9, 2026No Apparent Adverse Event
IT WAS REPORTED THAT THE DEVICE EXPERIENCED AN UNDETERMINED FAILURE DURING SURGERY. DURING MANUFACTURER'S INVESTIGATION OF THE RETURNED DEVICE IT WAS IDENTIFIED THAT THE WELD BETWEEN THE CARDAN AND HEX SWIVEL, BROKE, RESULTING IN THE HEX SWIVEL DETACHING FROM THE DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24291769 ↗MalfunctionJun 10, 2025Break; Break
IT WAS REPORTED THAT THE CARDAN DRIVER BROKE FOLLOWED BY KNUCKLE DRIVER BREAKING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22176931 ↗MalfunctionJan 15, 2025Break; Break
IT WAS REPORTED THAT THE DOCTOR WAS IMPLANTING A SCREW WITH THE CARDAN SCREWDRIVER ON POWER, AND WHILE IMPLANTING THE END OF THE SCREWDRIVER BROKE. THE DOCTOR HAD TO DRILL THE TIP OF THE SCREWDRIVER EXTENDING THE CASE 10 MINUTES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21158981 ↗MalfunctionSep 16, 2024Break; Break
IT WAS REPORTED THAT PATIENT HAD TOTAL HIP. ONE INSTRUMENT BROKE DURING THE CASE. THERE WAS BACKUPS AVAILABLE SO THERE WAS NO DELAYS IN SURGERY.
Patient problems: Insufficient Information
MAUDE report 20224294 ↗MalfunctionAug 14, 2024Break; Break
ADDITIONAL INFORMATION RECEIVED STATES THAT THERE WAS NO ADVERSE CONSEQUENCE AND ALL BROKEN PIECES WERE RETRIEVED FROM THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19981334 ↗MalfunctionMar 5, 2024Break; Break
IT WAS REPORTED THAT THE TIP OF PINNACLE SCREWDRIVER IS BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18835533 ↗MalfunctionJul 14, 2023Break; Break
IT WAS REPORTED THAT SCREWDRIVER BROKE . SURGICAL DELAY UNKNOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17327523 ↗MalfunctionMay 22, 2023Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE SCREWDRIVER RATCHET MECHANISM BROKE WHILE INSERTING THE SCREW. THE WELD BROKE ON THE CUP IMPACTOR HANDLE ABOVE THE GRIP, AND THE QUICK CONNECT END WOULDN¿T FIT ALL THE WAY INTO SCREWDRIVER HANDLE. NO DELAYS OR PATIENT HARM OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16975753 ↗MalfunctionMay 1, 2023Break; Break
IT WAS REPORTED THAT DURING CASE PHYSICIAN WAS TIGHTENING SCREW. IN THE PROCESS THE DRILL BIT BROKE AND WAS ATTACHED TO THE HEAD OF THE SCREW. IT TOOK THE PHYSICIAN TWENTY MINUTES TO REMOVE THE BROKEN HEX DRILL BIT. X RAYS WERE PERFORMED.
Patient problems: Insufficient Information
MAUDE report 16846069 ↗MalfunctionJan 23, 2023Break; Break
IT WAS REPORTED THAT THE SCREW DRIVER BROKE (TIP). NO DELAY IN THE CASE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16225023 ↗MalfunctionJan 19, 2023Break; Device-Device Incompatibility; Break; Device-Device Incompatibility
IT WAS REPORTED THAT THE SCREW BROKE AND STUCK ON DRIVER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16204896 ↗MalfunctionJan 9, 2023Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT SCREWDRIVER ENDS STICKING IN SCREWS. THERE WAS NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16122448 ↗MalfunctionJan 9, 2023Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT SCREWDRIVER ENDS STICKING IN SCREWS. THERE WAS NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16122397 ↗MalfunctionJan 9, 2023Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT SCREWDRIVER ENDS STICKING IN SCREWS. THERE WAS NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16122338 ↗MalfunctionJan 9, 2023Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT SCREWDRIVER ENDS STICKING IN SCREWS. THERE WAS NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16122321 ↗MalfunctionJan 9, 2023Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT SCREWDRIVER ENDS STICKING IN SCREWS. THERE WAS NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16122297 ↗MalfunctionJan 9, 2023Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT SCREWDRIVER ENDS STICKING IN SCREWS. THERE WAS NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16122288 ↗MalfunctionJan 9, 2023Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT SCREWDRIVER ENDS STICKING IN SCREWS. THERE WAS NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16122264 ↗MalfunctionJan 9, 2023Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT SCREWDRIVER ENDS STICKING IN SCREWS. THERE WAS NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16122240 ↗MalfunctionDec 27, 2022Break; Break
SCREWDRIVER BROKE WHEN PUTTING IN SCREW. NO SURGICAL DELAY. NO ADVERSE AFFECTS ON THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16056163 ↗MalfunctionSep 12, 2022Break; Break
IT WAS REPORTED THAT THE SWIVEL HEAD SHATTERED WHEN INSERTING SCREW.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15405572 ↗MalfunctionJun 15, 2022Break; Entrapment of Device; Break; Entrapment of Device
IT WAS REPORTED THAT THE TIP BROKE OFF THE DRIVER DURING SCREW INSERTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14695047 ↗MalfunctionJun 3, 2022Break; Break
IT WAS REPORTED THAT THE TIP OF THE SCREW DRIVER BROKE OFF. BOTH PIECE FOUND AND THROWN AWAY. NO DELAY IN SURGERY, NO OTHER INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14593407 ↗MalfunctionDec 8, 2021Failure to Cut; Failure to Cut
IT WAS REPORTED THAT THE HEX HEAD IS DULL AND WILL NOT ARTICULATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12959602 ↗MalfunctionOct 1, 2021Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE SCREWDRIVER TIP WOULD NOT SEAT INTO SCREW HEAD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12561241 ↗
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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