SPECIALIST 96-6295Recalls & reported problems
Depuy (Ireland) · SPECIALIST 2 FEMORAL BOX TRIAL SCREWDRIVER 2.5mm · Class 1
All models of SPECIALIST (80)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This DePuy Specialist femoral box trial screwdriver is a surgical instrument used during hip replacement trials. The 47 reports mostly describe the tip wearing down, stripping, or bending so it no longer grips screws, and trial components getting stuck during the procedure; none describe patient injuries or 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
- 48
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 48 adverse event reports that list this exact device (DI 10603295247739), received between Sep 22, 2017 and Sep 16, 2026 — classified as 48 malfunctions.
The most frequently reported specific device problem is “Material Twisted/Bent” (18 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Material Twisted/Bent18
- Naturally Worn18
- Material Deformation10
- Break5
- Device-Device Incompatibility2
- Dull, Blunt2
- Appropriate Device Problem Term/Code Not Available1
- Device Slipped1
Patient problems
- No Consequences Or Impact To Patient27
- No Clinical Signs, Symptoms or Conditions16
- No Code Available6
- No Information3
- Not Applicable2
Recent adverse event reports
The 25 most recent of 48 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 16, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50794165 ↗MalfunctionApr 27, 2023Naturally Worn; Naturally Worn
IT WAS REPORTED THAT THE SCREWDRIVER STRIPPED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16823183 ↗MalfunctionMar 27, 2023Naturally Worn; Naturally Worn
IT WAS REPORTED THAT BOX TRIAL IS STRIPPED, SCREWDRIVER DOES NOT CAPTURE SCREWS. SURGICAL DELAY UNKNOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16618568 ↗MalfunctionMar 16, 2023Naturally Worn; Naturally Worn
IT WAS REPORTED THAT SZ 4 AND 5 TC3 BOX TRIALS BENT AT BOTTOM. PIECE REMOVED AND TOSSED. SCREWDRIVER STRIPPED. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16551624 ↗MalfunctionFeb 22, 2023Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE NOTCH TRIAL IS STUCK ON FEMORAL TRIAL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16416879 ↗MalfunctionJan 26, 2023Naturally Worn; Naturally Worn
IT WAS REPORTED THE SCREWDRIVER IS NOT CATCHING SCREW ANYMORE AND IT IS BROKEN. NO SURGICAL DELAY. NO ADVERSE AFFECTS ON THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16247069 ↗MalfunctionDec 7, 2022Naturally Worn; Naturally Worn
IT WAS REPORTED THAT THE SIZE 3 BOX TRIAL IS STUCK ON FEMUR TRIAL. SCREWDRIVER IS STRIPPED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15932091 ↗MalfunctionMar 4, 2022Naturally Worn; Naturally Worn
SCREWDRIVER IS STRIPPED AND NO LONGER FUNCTIONAL. ALTERNATIVE SCREW WAS USED TO FINISH THE CASE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13667754 ↗MalfunctionFeb 7, 2022Naturally Worn; Naturally Worn
INSTRUMENTS ARE NOT WORKING. SURGICAL DELAY OF 10 MINUTES OCCURRED. THE BOLT THAT TIGHTENS THE FEMORAL SLEEVE TO THE BACK OF A TC3 FEMUR LOOSENS AND ROTATES THE SLEEVE WHEN THE TRIAL IS REMOVED AND THE CORRECT ROTATION IS THEN LOST. ISSUE MAY BE A RESULT OF WEAR AND TEAR. NO ADVERSE AFFECTS ON PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13472692 ↗MalfunctionOct 11, 2021Naturally Worn; Naturally Worn
IT WAS REPORTED THAT THE HEX HEAD IS STRIPPED AND NEEDS REPLACING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12605847 ↗MalfunctionSep 20, 2021Device-Device Incompatibility; Naturally Worn; Device-Device Incompatibility; Naturally Worn
ADDITIONAL INFORMATION RECEIVED INDICATED THAT THERE WAS NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12495379 ↗MalfunctionAug 10, 2021Naturally Worn; Naturally Worn
IT WAS REPORTED THAT THE SCREWDRIVERS ARE JUST WORN AND NOT WORKING OPTIMALLY. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12300283 ↗MalfunctionAug 10, 2021Naturally Worn; Naturally Worn
IT WAS REPORTED THAT THE SCREWDRIVERS ARE JUST WORN AND NOT WORKING OPTIMALLY. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12300281 ↗MalfunctionJun 25, 2021Material Twisted/Bent; Naturally Worn; Material Twisted/Bent; Naturally Worn
ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE PIECES WERE NOT BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12067054 ↗MalfunctionJan 6, 2021Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT THE SCREWDRIVER IS STRIPPED. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11123033 ↗MalfunctionDec 22, 2020Material Twisted/Bent; Material Twisted/Bent
IT WAS NOTICED BY THE SCRUB TECH THAT THE BLACK HANDLE THAT IS USED TO TIGHTEN THE PS BOX ONTO THE FEMORAL COMPONENT HAD BEEN STRIPPED. THE DRIVER AND BOX BOTH ARE STRIPPED, BUT DID NOT BREAK INTO PIECES THEREFORE THE TWO INSTRUMENTS ARE IN FULL CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11057843 ↗MalfunctionNov 17, 2020Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT THE SIGMA SCREWDRIVER WAS ROUNDED OFF AND WILL NOT LOOSEN BOX TRIALS. NO FURTHER INFORMATION WAS AVAILABLE. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10853211 ↗MalfunctionOct 23, 2020Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT THE SCREW DRIVER TIP WAS STRIPPED. SZ 4 NOTCH TRIAL SCREW HEAD WAS STRIPPED. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10730383 ↗MalfunctionOct 15, 2020Material Deformation; Material Twisted/Bent; Material Deformation; Material Twisted/Bent
IT WAS REPORTED THAT THE TIPS OF THE SCREWDRIVERS ARE ROUNDED OFF. NO SURGICAL DELAY.
Patient problems: No Code Available; No Consequences Or Impact To Patient
MAUDE report 10684185 ↗MalfunctionOct 15, 2020Material Deformation; Material Twisted/Bent; Material Deformation; Material Twisted/Bent
IT WAS REPORTED THAT THE TIPS OF THE SCREWDRIVERS ARE ROUNDED OFF. NO SURGICAL DELAY.
Patient problems: No Code Available; No Consequences Or Impact To Patient
MAUDE report 10684176 ↗MalfunctionSep 16, 2020Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT THE SCREWDRIVER AND BOX TRIAL ARE STRIPPED. NO SURGICAL DELAY.
Patient problems: No Code Available; No Consequences Or Impact To Patient
MAUDE report 10540562 ↗MalfunctionAug 19, 2020Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT THE SIGMA FEMORAL SCREWDRIVER HAS ROUNDED OFF AT THE TIP AND NEEDS REPLACING. NO FURTHER INFORMATION IS AVAILABLE. NO SURGICAL DELAY.
Patient problems: No Code Available; No Consequences Or Impact To Patient
MAUDE report 10427243 ↗MalfunctionAug 5, 2020Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT BOTH HEX DRIVERS ARE STRIPPED AT THE ENDS AND WILL NOT TURN SCREWS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10370652 ↗MalfunctionAug 5, 2020Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT BOTH HEX DRIVERS ARE STRIPPED AT THE ENDS AND WILL NOT TURN SCREWS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10370651 ↗MalfunctionJul 29, 2020Material Integrity Problem; Material Integrity Problem
IT WAS REPORTED THAT THE SET SCREW DRIVER IS NOT WORKING. NO SURGICAL DELAY.
Patient problems: No Code Available; No Consequences Or Impact To Patient
MAUDE report 10339257 ↗
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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