NA 2046-10-000Recalls & reported problems
Depuy (Ireland) · DRIVER EXTRACTOR · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This is a DePuy driver extractor, a surgical tool used to knock out or drive out an implant stem during hip surgery. The reports mostly describe the tool deforming, bending, twisting or breaking during use, sometimes leaving a bent extractor behind after the stem was removed, plus rust on the shaft and one case where the handle was missing. There are 35 reports, with no deaths and no injuries. 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
- 35
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 35 adverse event reports that list this exact device (DI 10603295084365), received between Aug 8, 2018 and Apr 17, 2026 — classified as 35 malfunctions.
The most frequently reported specific device problem is “Material Deformation” (13 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
- Material Deformation13
- Break8
- Material Twisted/Bent8
- Mechanical Jam4
- Device-Device Incompatibility3
- Component Missing2
- Naturally Worn2
- No Apparent Adverse Event2
Patient problems
- No Clinical Signs, Symptoms or Conditions21
- No Consequences Or Impact To Patient11
- Insufficient Information2
- No Code Available1
- Not Applicable1
Recent adverse event reports
The 25 most recent of 35 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 17, 2026Break
IT WAS REPORTED THAT THE DRIVER EXTRACTOR BROKE DURING EXTRACTION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24912016 ↗MalfunctionJan 8, 2026Corroded
IT WAS REPORTED THAT THE PROSTALAC EXTRACTOR ROD SHOWED RUST ALONG THE SHAFT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24011454 ↗MalfunctionAug 4, 2025Material Deformation; Material Deformation
IT WAS REPORTED THAT THE HANDLE OF THE EXTRACTOR IS BENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22704078 ↗MalfunctionJun 17, 2025Material Deformation; Material Deformation
IT WAS REPORTED THAT THE HANDLE IS BENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22226561 ↗MalfunctionFeb 20, 2025Break; Material Deformation; Break; Material Deformation
IT WAS REPORTED THAT THE SLAP HAMMER WAS BENT AT THE THREADED END. THREADED PIECE THAT SCREWS IN WAS ALSO BROKEN.
Patient problems: Insufficient Information
MAUDE report 21426159 ↗MalfunctionFeb 6, 2025Material Deformation; Material Deformation
IT WAS REPORTED THAT THE TOTAL HIP, EXTRACTION OF STEM SLAP HAMMER SHAFT BENT. IT WAS UNKNOWN IF THE SURGERY WAS DELAYED OR IF THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT STATUS/ OUTCOME / CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21322978 ↗MalfunctionDec 3, 2024Material Deformation; Material Deformation
ADDITIONAL INFORMATION RECEIVED STATES THAT THE STEM WAS REMOVED BY THE BENDED EXTRACTOR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20836664 ↗MalfunctionNov 11, 2024No Apparent Adverse Event; No Apparent Adverse Event
IT WAS REPORTED THAT THE FOLLOWING DEVICE WAS RECEIVED AS BLIND UNIT. HOWEVER, IT COULDN'T BE ASSOCIATED WITH A COMPLAINT OR ANY OTHER EXISTING RECORD. AS A RESULT, THIS COMPLAINT WAS CREATED TO ANALYZE THE RETURNED DEVICE. DURING MANUFACTURER'S INVESTIGATION OF THE RETURNED DEVICE IT WAS IDENTIFIED THAT THE OVERALL SURFACE OF THE DEVICE EXHIBITS IMPACTIONS MARKS AND NICKS. ADDITIONALLY, THE SLIDE HAMMER HANDLE COMPONENT WAS MISSING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20651771 ↗MalfunctionSep 16, 2024Material Deformation; Material Deformation
ADDITIONAL INFORMATION WAS RECEIVED: A. WAS THERE A SURGICAL DELAY? IF YES, WHAT IS THE DURATION OF THE DELAY? NO SURGICAL DELAY. B. WAS THERE ANY ADVERSE CONSEQUENCES THAT AFFECTED THE PATIENT BECAUSE OF THE REPORTED EVENT? NO ADVERSE EFFECTS
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 20226678 ↗MalfunctionAug 23, 2024No Apparent Adverse Event; No Apparent Adverse Event
INSTRUMENT WAS REPORTED FOR UNKNOWN REASON. IT DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20052110 ↗MalfunctionMar 18, 2024Mechanical Jam; Mechanical Jam
IT WAS REPORTED THAT SLAP HAMMER STICKS AND GOT STUCK. IT DIDN¿T WORK.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18923493 ↗MalfunctionNov 30, 2023Material Deformation; Material Deformation
IT WAS REPORTED THAT SURGEON WAS USING SLAP HAMMER AND THE SLAP HAMMER BENT DUE TO THE FORCE. IT HAD TO ABANDON AND SURGEON DID AN ETO.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18242737 ↗MalfunctionJul 28, 2023Material Deformation; Material Deformation
IT WAS REPORTED THAT SLAP HAMMER SHAFT IS DENTED FROM REPEATED USE AND IS NO LONGER FUNCTIONAL. THERE WAS NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17416035 ↗MalfunctionApr 18, 2023Material Deformation; Material Deformation
IT WAS REPORTED THAT LONG SHAFT ON THE SROM STEM EXTRACTOR BENT WHILE TRYING TO REMOVE A STEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16766180 ↗MalfunctionApr 11, 2023Material Deformation; Material Deformation
ADDITIONAL INFORMATION WAS RECEIVED. AND STATED, THAT MENTIONED, THAT THERE WERE NO SURGICAL DELAYS. AND ADVERSE CONSEQUENCES OCCURRED. THE HIP REVISION DID NOT INVOLVE DEPUY PRODUCTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16712640 ↗MalfunctionNov 15, 2022Break; Break
IT WAS REPORTED THAT THE INSTRUMENT BROKE WHILE EXTRACTING. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15797344 ↗MalfunctionJun 15, 2022Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE BACK SLAP HANDLE KEPT STICKING TO THE ROD EXTRACTOR. THERE WAS A SURGICAL DELAY OF 1 MINUTE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14697259 ↗MalfunctionFeb 21, 2022Break; Break
IT WAS REPORTED THAT THE ADAPTER BOLT DISENGAGED FROM THE THREADS WHILE USING THE SLAP HAMMER AND REMOVED THE THREADS INSIDE THE SLAP HAMMER HANDLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13569518 ↗MalfunctionNov 16, 2021Naturally Worn; Naturally Worn
IT WAS REPORTED THAT THE SLAP HAMMER WAS CROSS-THREADED AND THE FEMORAL STEM EXTRACTOR DOES NOT CLAMP ONTO TRUNION, WOULD TIGHTEN BUT NOT ACTUALLY GRAB. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12819946 ↗MalfunctionAug 30, 2021Material Deformation; Material Deformation
IT WAS REPORTED THAT THE INSTRUMENT BENT WHILE EXTRACTING AN IMPLANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12385633 ↗MalfunctionFeb 5, 2021Break; Break
IT WAS REPORTED THAT THE 32 MM IMPACTOR TIP WORN, OLD, CRACKING. FOUND WHEN SET RETURNED TO THE OFFICE FOR INSPECTION. 36 MM IMPACTOR TIP WORN, OLD, CRACKING. FOUND WHEN SET RETURNED TO THE OFFICE FOR INSPECTION. T-HANDLE CRACKED. FOUND WHEN SET RETURNED TO THE OFFICE FOR INSPECTION. DRIVER EXTRACTOR SEPARATED. FOUND WHEN SET RETURNED TO THE OFFICE FOR INSPECTION. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11286407 ↗MalfunctionJan 29, 2021Break; Break
IT WAS REPORTED THAT THE SLAP HAMMER IN PROSTALAC SET BROKE AT THE HANDLE. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11254239 ↗MalfunctionSep 18, 2020Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking
IT WAS REPORTED THAT THE SURGEON WAS ATTEMPTING TO BROACH THE FEMORAL CANAL OF PATIENT INDICATED ABOVE. THE BROACH GOT STUCK IN THE CANAL, SO THEY HAD TO OPEN THE STEM REMOVAL TRAY, WHICH INCLUDED A DEPUY SLAP HAMMER. WITH THE USE OF A DEPUY ADAPTER, THE SLAP HAMMER WAS ATTACHED TO THE STEM DISTRACTOR AND AN ATTEMPT WAS MADE TO REMOVE THE BROACH FROM THE PATIENT'S CANAL. UNFORTUNATELY, IN THE PROCESS, THE SLAP HAMMER AND ADAPTER WAS DAMAGED BEYOND REPAIR. TO REVIEW. ONE SLAP HAMMER WAS DAMAGED AS WELL AS ONE ADAPTER, THE CASE WAS DELAYED , BUT THE SURGEON UNDERSTOOD , CONSIDERING THE CIRCUMSTANCES. ALL BROKEN PIECES WERE RETRIEVED AND HE APOLOGIZED FOR THE DAMAGE. THERE WAS 90 MINUTES SURGICAL DELAY.
Patient problems: No Code Available
MAUDE report 10554506 ↗MalfunctionJun 10, 2020Break; Break
EXPLANT INFECTED TOTAL HIP IMPLANTS AND INSERTION PROSTALAC ANTIBIOTIC SPACER. EXPLANTED IMPLANTS: CORAIL COLLARLESS STEM, 36, 1.5MM DELTA TS HEAD, 36X52, +4 NEUTRAL LINER. 1 BONE SCREW, PINNACLE 52MM SECTOR CUP.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10137600 ↗MalfunctionJan 24, 2020Crack; Component Missing; Material Deformation; Material Twisted/Bent; Crack; Component Missing; Material Deformation; Material Twisted/Bent
IT WAS REPORTED THAT THE DRIVER EXTRACTOR THREADS STRIPPED, EXTRACTOR TIP SPLIT. FOUND WHEN SET RETURNED TO THE OFFICE FOR INSPECTION.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9629808 ↗
Other EXTRACTOR devices
- ATTUNE 2545-00-138Depuy (Ireland) · EXTRACTOR392 reports
- PINNACLE 2217-50-001Depuy (Ireland) · EXTRACTOR243 reports
- RECLAIM 2975-00-635Depuy (Ireland) · EXTRACTOR157 reports
- ATTUNE 2545-00-060Depuy (Ireland) · EXTRACTOR153 reports
- ESC PINNACLE 2218-00-010Depuy (Ireland) · EXTRACTOR151 reports
- NA 2125-00-600Depuy Orthopaedics, Inc. · EXTRACTOR130 reports
- P.F.C. 86-5226Depuy (Ireland) · EXTRACTOR80 reports
- NA 03.010.000Synthes GmbH · EXTRACTOR74 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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