NA MWD553Recalls & reported problems
Tornier · Open-End Wrench · Class 1
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 03700386983214), received between Feb 18, 2025 and Feb 18, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Component Missing” (1 report).
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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Component Missing1
- Device Damaged Prior to Receipt by User1
Patient problems
- Insufficient Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 18, 2025Device Damaged Prior to Receipt by User; Component Missing; Device Damaged Prior to Receipt by User; Component Missing
IT WAS REPORTED THAT DURING A SURGERY TWO REFERENCES WERE MISSING FROM THE KIT, AND IT CAUSED A DELAY ON SURGERY. DUE TO THE MISSING INSTRUMENTS MWD423 AND MWD553, THE FINAL TIGHTENING SCREW FOR THE IMPLANT WAS MISSING. THIS HAS LED TO CONSEQUENTIAL PROBLEMS IN THE FINAL IMPLANTATION.
Patient problems: Insufficient Information
MAUDE report 21406889 ↗
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- P.F.C. 86-5189Depuy (Ireland) · WRENCH92 reports
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- RECLAIM 2975-00-300Depuy (Ireland) · WRENCH51 reports
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- 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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