NA 388.266Recalls & reported problems
Synthes GmbH · 10NM TORQUE LIMITING WRENCH FOR 12-POINT NUT · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10705034772271), received between Sep 13, 2019 and Dec 30, 2020 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Calibration Problem” (4 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.
Most reported problems
Device problems
- Calibration Problem4
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- No Patient Involvement2
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 30, 2020Calibration Problem; Calibration Problem
IT WAS REPORTED ON (B)(6) 2020, DURING EVALUATION AT SERVICE AND REPAIR, THE 10NM TORQUE LIMITING WRENCH FOR 12-POINT NUT WAS FOUND TO HAVE FAILED CALIBRATION. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) 10NM TORQUE LIMITING WRENCH FOR 12-POINT NUT. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11097562 ↗MalfunctionDec 16, 2020Calibration Problem; Calibration Problem
IT WAS REPORTED THAT ON AN UNKNOWN DATE THAT THE TORQUE WRENCH FAILED CALIBRATION. THIS REPORT IS FOR 1 10NM TORQUE LIMITING WRENCH FOR 12-POINT NUT. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11022447 ↗MalfunctionFeb 13, 2020Calibration Problem; Calibration Problem
IT WAS REPORTED THAT ON (B)(6) 2020 DURING TESTING AT SERVICE AND REPAIR, THE TORQUE LIMITING WRENCH FOR 12 POINT NUT FAILED IN CALIBRATION. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE 10NM TORQUE LIMITING WRENCH FOR 12-POINT NUT. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: No Patient Involvement
MAUDE report 9708237 ↗MalfunctionSep 13, 2019Calibration Problem; Calibration Problem
IT WAS REPORTED ON (B)(6) 2019, DURING TESTING AT SERVICE AND REPAIR, THE TORQUE LIMITING WRENCH WAS FOUND THAT THIS DEVICE FAILED IN CALIBRATION. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS 1 OF 1 FOR (B)(4).
Patient problems: No Patient Involvement
MAUDE report 9050575 ↗
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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