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NA 399.16Recalls & reported problems

Synthes GmbH · HOLDING FORCEPS FOR TIBIAL EDGE FRAGMENTS 210MM · 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 10886982202468), received between Dec 7, 2020 and Dec 7, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Deformation” (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

  • Material Deformation1

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.

  • MalfunctionDec 7, 2020Material Deformation; Material Deformation

    IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE HOLDING FORCEPS FOR TIBIAL EDGE FRAGMENTS WAS DISCOVERED BENT. THERE WAS NO PATIENT INVOLVEMENT. DURING INVESTIGATION BY THE MANUFACTURER, IT WAS NOTED THAT THE CONE COMPONENT ON THE FORCEPS WAS BROKEN. THIS REPORT IS FOR A HOLDING FORCEPS. THIS IS REPORT 1 OF 1 (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 10959563 ↗

Other FORCEPS devices

All FORCEPS devices →

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