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NA 395.304Recalls & reported problems

Synthes GmbH · SOCKET WRENCH 5.5MM · Class 2

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 10886982200235), received between Apr 23, 2020 and Apr 23, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (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.

Most reported problems

Device problems

  • Break1

Patient problems

  • No Consequences Or Impact To Patient1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionApr 23, 2020Break; Break

    IT WAS REPORTED THAT ON AN UNKNOWN DATE THE FSL SET MINI EXTERNAL FIXATOR WAS DELIVERED WITH A BROKEN INSTRUMENT. THE HOSPITAL STAFF DID NOT NOTICE UNTIL THEY OPENED THE TRAY FOR HAND SURGERY ON (B)(6) 2020. THEY WERE ABLE TO COMPLETE THE PROCEDURE WITH K-WIRES AND DID NOT USE THE MINI EXTERNAL FIXATOR SET. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PATIENT AND PROCEDURE OUTCOME WERE UNKNOWN. THIS REPORT IS FOR ONE (1) SOCKET WRENCH 5.5MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 9991026 ↗

Other PLATE, BONE devices

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Sources and updates

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