APEX 2346-01-000Recalls & reported problems
Depuy (Ireland) · APEX HOLE ELIMINATOR TPRD HEX DRIVER · Class 1
All models of APEX (2)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This DePuy APEX hex screwdriver is a surgical instrument. The 24 reports mostly describe worn, cracked, bent, or broken parts that no longer connect or screw in properly, including instruments breaking during surgery. There were no deaths or injuries, and no recalls name this device. Reports fell from 3 in the previous 12 months to 0 in the latest 12 months.
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
- 24
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 10603295119715), received between Sep 26, 2017 and Jun 26, 2025 — classified as 24 malfunctions.
The most frequently reported specific device problem is “Naturally Worn” (10 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 Worn10
- Break7
- Device-Device Incompatibility6
- Material Twisted/Bent6
- Material Deformation4
- Appropriate Device Problem Term/Code Not Available2
Patient problems
- No Clinical Signs, Symptoms or Conditions13
- No Consequences Or Impact To Patient7
- No Information3
- Not Applicable1
Recent adverse event reports
The 24 most recent of 24 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 26, 2025Break; Break
IT WAS REPORTED THAT THERE WERE BROKEN INSTRUMENTS DURING SURGERY. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22338558 ↗MalfunctionJun 26, 2025Break; Break
IT WAS REPORTED THAT THERE WERE BROKEN INSTRUMENTS DURING SURGERY. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22338535 ↗MalfunctionJun 26, 2025Break; Break
IT WAS REPORTED THAT THERE WERE BROKEN INSTRUMENTS DURING SURGERY. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22338530 ↗MalfunctionJan 3, 2023Device-Device Incompatibility; Naturally Worn; Device-Device Incompatibility; Naturally Worn
ALL 28/32/36MM LINER TRIALS REQUIRE REPLACEMENT DUE TO BEING CRACKED, CROSS THREADED, DISCOLOURED AND CHIPPED. THEY ARE NO LONGER USABLE WITH THE SCREWDRIVER AND THEREFORE DO NOT SCREW IN PROPERLY TO THE TRIAL CUP. THESE LINER TRIALS ARE IN ROUGH SHAPE DUE TO SEVERAL YEARS OF USE/WEAR AND TEAR. NO REPORTED PATIENT CONSEQUENCES. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16088680 ↗MalfunctionJan 3, 2023Device-Device Incompatibility; Naturally Worn; Device-Device Incompatibility; Naturally Worn
ALL 28/32/36MM LINER TRIALS REQUIRE REPLACEMENT DUE TO BEING CRACKED, CROSS THREADED, DISCOLOURED AND CHIPPED. THEY ARE NO LONGER USABLE WITH THE SCREWDRIVER AND THEREFORE DO NOT SCREW IN PROPERLY TO THE TRIAL CUP. THESE LINER TRIALS ARE IN ROUGH SHAPE DUE TO SEVERAL YEARS OF USE/WEAR AND TEAR. NO REPORTED PATIENT CONSEQUENCES. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16088660 ↗MalfunctionJan 3, 2023Device-Device Incompatibility; Naturally Worn; Device-Device Incompatibility; Naturally Worn
ALL 28/32/36MM LINER TRIALS REQUIRE REPLACEMENT DUE TO BEING CRACKED, CROSS THREADED, DISCOLOURED, AND CHIPPED. THEY ARE NO LONGER USABLE WITH THE SCREWDRIVER AND THEREFORE DO NOT SCREW IN PROPERLY TO THE TRIAL CUP. THESE LINER TRIALS ARE IN ROUGH SHAPE DUE TO SEVERAL YEARS OF USE/WEAR AND TEAR. NO REPORTED PATIENT CONSEQUENCES. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16088446 ↗MalfunctionJan 3, 2023Device-Device Incompatibility; Naturally Worn; Device-Device Incompatibility; Naturally Worn
THE 28 AND 32MM LINER IMPACTOR TIPS ARE BURRED AND SCRATCHED UP DUE TO WEAR AND TEAR. THE HEX LINER SCREWDRIVERS ARE STRIPPED ON THE BOTTOM AND HAVE WORN DOWN OVER TIME. THEY NO LONGER CONNECT INTO THE TRIAL LINER. THE PINNACLE STRAIGHT CUP INSERTERS HAVE BROKEN OFF STRIKE PLATES ON THE PROXIMAL END OF THE INSTRUMENT. THEY CAN NO LONGER IMPACT PINNACLE CUPS. THE STANDARD AND HIGH OFFSET NECK TRIALS ARE BURRED ON THE INSIDE AND NO LONGER CONNECT PROPERLY TO A TRIAL BROACH. THERE WERE NO PATIENT CONSEQUENCES. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16085615 ↗MalfunctionJan 3, 2023Device-Device Incompatibility; Naturally Worn; Device-Device Incompatibility; Naturally Worn
THE 28 AND 32MM LINER IMPACTOR TIPS ARE BURRED AND SCRATCHED UP DUE TO WEAR AND TEAR. THE HEX LINER SCREWDRIVERS ARE STRIPPED ON THE BOTTOM AND HAVE WORN DOWN OVER TIME. THEY NO LONGER CONNECT INTO THE TRIAL LINER. THE PINNACLE STRAIGHT CUP INSERTERS HAVE BROKEN OFF STRIKE PLATES ON THE PROXIMAL END OF THE INSTRUMENT. THEY CAN NO LONGER IMPACT PINNACLE CUPS. THE STANDARD AND HIGH OFFSET NECK TRIALS ARE BURRED ON THE INSIDE AND NO LONGER CONNECT PROPERLY TO A TRIAL BROACH. THERE WERE NO PATIENT CONSEQUENCES. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16085611 ↗MalfunctionJan 3, 2023Device-Device Incompatibility; Naturally Worn; Device-Device Incompatibility; Naturally Worn
THE 28 AND 32MM LINER IMPACTOR TIPS ARE BURRED AND SCRATCHED UP DUE TO WEAR AND TEAR. THE HEX LINER SCREWDRIVERS ARE STRIPPED ON THE BOTTOM AND HAVE WORN DOWN OVER TIME. THEY NO LONGER CONNECT INTO THE TRIAL LINER. THE PINNACLE STRAIGHT CUP INSERTERS HAVE BROKEN OFF STRIKE PLATES ON THE PROXIMAL END OF THE INSTRUMENT. THEY CAN NO LONGER IMPACT PINNACLE CUPS. THE STANDARD AND HIGH OFFSET NECK TRIALS ARE BURRED ON THE INSIDE AND NO LONGER CONNECT PROPERLY TO A TRIAL BROACH. THERE WERE NO PATIENT CONSEQUENCES. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16085556 ↗MalfunctionMar 29, 2022Naturally Worn; Naturally Worn
IT WAS REPORTED THAT TIP OF SCREWDRIVER IS WORN OUT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13937939 ↗MalfunctionSep 7, 2021Naturally Worn; Naturally Worn
IT WAS REPORTED THAT THE 32X48N TRIAL LINER, A 32X50N TRIAL LINER AND A WHITE HANDLE SCREW DRIVER WERE STRIPPED. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12434045 ↗MalfunctionJul 1, 2021Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT ACCORDING TO SURGEON, WHITE HEX SCREWDRIVER OR TRIAL LINER ARE WORN AND NOT OPERATING AS EXPECTED, MAKING IT DIFFICULT TO INSERT TRIAL LINERS OR SCREWS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12104248 ↗MalfunctionJun 3, 2021Material Twisted/Bent; Material Twisted/Bent
BROKEN WHITE T-HANDLE, DULL CALCAR PLANAR, STRIPPED LINER TRIAL, CRACKED CUP INSERTER, STRIPPED SCREWDRIVER NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11928808 ↗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 10099121 ↗MalfunctionJan 24, 2020Break; Material Deformation; Material Twisted/Bent; Break; Material Deformation; Material Twisted/Bent
BROKEN THREAD ON PINNACLE INSERTER HANDLE AND PINNACLE SCREW DRIVER. NO ADVERSE AFFECTS OCCURRED DURING THE SURGERY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9628713 ↗MalfunctionNov 22, 2019Material Deformation; Material Twisted/Bent; Material Deformation; Material Twisted/Bent
IT WAS REPORTED THAT THE SCREW DRIVER IS STRIPPED AND NEEDS REPLACED. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9364002 ↗MalfunctionOct 25, 2019Naturally Worn; Naturally Worn
MalfunctionMar 27, 2019Material Deformation; Material Twisted/Bent; Naturally Worn; Material Deformation; Material Twisted/Bent; Naturally Worn
IT WAS REPORTED THAT THE SCREW DRIVER WAS DAMAGED AND STRIPPED . THERE WAS 5 MINUTES SURGICAL DELAY.
Patient problems: Not Applicable
MAUDE report 8456873 ↗MalfunctionJan 14, 2019Material Deformation; Material Deformation
IT WAS REPORTED THAT THE SCREW DRIVER IS STRIPPED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8245038 ↗MalfunctionAug 13, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT SCREW HEAD IS STUCK ON SCREW DRIVER. NEEDS TO BE REPLACED. THERE WAS NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7776903 ↗MalfunctionJan 12, 2018Break; Break
TIP OF THE SCREWDRIVER IS BROKEN, DOESN¿T HOLD A SCREW ANYMORE. (B)(4). PATIENT CONSEQUENCE? :NO. ACTION TAKEN FOR PROCEDURE: COMPLETE WITH SAME PRODUCT. IS THE INFORMATION BEING SUBMITTED FOR THIS COMPLAINT ALL THE DETAILS THAT ARE KNOWN/AVAILABLE REGARDING THIS EVENT? : YES.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7185422 ↗MalfunctionNov 21, 2017Break; Break
IT WAS REPORTED THAT THE SPD FOUND A SCREWDRIVER BROKEN AFTER THE CASE. THERE WAS NO SURGERY TIME OR PATIENT AFFECTED. IT WAS ALSO REPORTED THAT THE REPLACEMENT SCREWDRIVER WAS FOUND TO BE STRIPPED.
Patient problems: No Information
MAUDE report 7047997 ↗MalfunctionNov 21, 2017Break; Break
IT WAS REPORTED THAT THE SPD FOUND A SCREWDRIVER BROKEN AFTER THE CASE. THERE WAS NO SURGERY TIME OR PATIENT AFFECTED. IT WAS ALSO REPORTED THAT THE REPLACEMENT SCREWDRIVER WAS FOUND TO BE STRIPPED.
Patient problems: No Information
MAUDE report 7047992 ↗MalfunctionSep 26, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT WHEN ATTEMPTING TO INSERT 6.5 MM PINNACLE BONE SCREW WITH STRAIGHT HEX HEAD SCREWDRIVER, THE SURGEON STATED THAT HEX WAS STRIPPED AND WOULD NOT TURN SCREW.
Patient problems: No Information
MAUDE report 6894778 ↗
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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