NA 03.602.014Recalls & reported problems
Synthes GmbH · SOCKET WRENCH WITH STRAIGHT HANDLE-11MM WIDTH ACROSS FLATS · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10705034712215), received between Dec 12, 2024 and Apr 21, 2026 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Compatibility Problem” (3 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
- Compatibility Problem3
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Insufficient Information1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 21, 2026Compatibility Problem
IT WAS REPORTED THAT ON (B)(6) 2026, THE WRENCH WILL NOT HOLD LOCKING NUTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24937810 ↗MalfunctionApr 9, 2025Compatibility Problem; Compatibility Problem
IT WAS REPORTED THAT THE USS COLLAR AND NUT IMPLANTS WOULD NOT STAY LOCKED IN THE WRENCH AND KEEP FALLING OUT. THERE WERE NO SURGICAL DELAY REPORTED AND PROCEDURE WAS SUCCESSFULLY COMPLETED. NO FRAGMENTS WERE GENERATED. THERE WERE NO OTHER MEDICAL INTERVENTION REQUIRED.
Patient problems: Insufficient Information
MAUDE report 21809527 ↗MalfunctionDec 12, 2024Compatibility Problem; Compatibility Problem
IT WAS REPORTED THAT ON (B)(6) 2024 AT THE END OF THE CASE WHEN THE NUT AND COLLARS WERE BEING APPLIED. THE NUTS KEPT ON FALLING OUT OF THE DRIVER. THE INSTRUMENT WAS REMOVED FROM THE FIELD. THIS WAS HAPPENING IN THE OPERATING ROOM. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20913985 ↗
Other WRENCH devices
- MONARCH 277040510Medos International Sàrl · WRENCH199 reports
- PINNACLE 2217-50-008Depuy (Ireland) · WRENCH108 reports
- SIGMA 96-1673Depuy (Ireland) · WRENCH102 reports
- P.F.C. 86-5189Depuy (Ireland) · WRENCH92 reports
- Veptr 03.641.004Synthes GmbH · WRENCH86 reports
- RECLAIM 2975-00-300Depuy (Ireland) · WRENCH51 reports
- PINNACLE 2217-50-006Depuy (Ireland) · WRENCH34 reports
- NA 388.261Synthes GmbH · WRENCH32 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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