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NA 398.811Recalls & reported problems

Synthes GmbH · PLATE HOLDING FORCEPS WITH SWIVEL FOOT/SIZE 0 · 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 10886982201676), received between May 29, 2019 and May 29, 2019 — 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 Patient Involvement1

Recent adverse event reports

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

  • MalfunctionMay 29, 2019Break; Break

    IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PLATE HOLDING FORCEPS WITH SWIVEL FOOT WAS FOUND BROKEN UPON OPENING THE PACKAGE AT THE HOSPITAL. THE SWIVEL FOOT WAS NOT ATTACHED TO THE FORCEPS. IT APPEARS TO BE MISSING THE PIN THAT HOLDS IT IN PLACE. THIS ITEM HAS NOT BEEN USED OR STERILIZED. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR A PLATE HOLDING FORCEPS. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Patient problems: No Patient Involvement

    MAUDE report 8650063 ↗

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.