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NA 324.003Recalls & reported problems

Synthes GmbH · PROXIMAL TIBIA LISS INSERTION GUIDE-LEFT · Class 1

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 10886982190888), received between Aug 31, 2023 and Aug 31, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device-Device Incompatibility” (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

  • Device-Device Incompatibility1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

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

  • MalfunctionAug 31, 2023Device-Device Incompatibility; Device-Device Incompatibility

    IT WAS REPORTED THAT ON AN UNKNOWN DATE, A SURGERY OCCURRED WHERE WE USED BILATERAL LISS PLATES. PLATES ATTACHED WERE BILLED TO PATIENT. SURGEON WANTS BOTH JIGS REPLACED DUE TO SLEEVES NOT SLIDING THROUGH AND MISSING JIG COMPLETELY ON BOTH SIDES. PIN WRENCH ALSO DID NOT FIT TO DEATTACH JIG. NO SURGICAL DELAY WAS REPORTED. NO PATIENT CONSEQUENCE WAS REPORTED. THIS REPORT IS FOR ONE (1) PROXIMAL TIBIA LISS INSERTION GUIDE-LEFT. THIS IS REPORT 1 OF 4 FOR COMPLAINT (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17661802 ↗

Other Guide, surgical, instrument devices

All Guide, surgical, instrument devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.