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NA 397.011Recalls & reported problems

Synthes GmbH · IMPLANT HOLDER-SLOT · Class 1

Adverse event reports
2
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705034778211), received between Aug 12, 2021 and Nov 12, 2021 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Material Integrity Problem” (2 reports).

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 Integrity Problem2

Patient problems

  • No Clinical Signs, Symptoms or Conditions2

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • MalfunctionNov 12, 2021Material Integrity Problem; Material Integrity Problem

    IT WAS REPORTED THAT, DURING THE REVERSE LOGISTICS AUDIT OF THE RETURNED DEVICE AT (B)(4) THE IMPLANT HOLDER SLOT WAS FOUND BROKEN. NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) IMPLANT HOLDER-SLOT. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12806397 ↗
  • MalfunctionAug 12, 2021Material Integrity Problem; Material Integrity Problem

    IT WAS REPORTED THAT IMPLANT HOLDER SLOT FOR FEMORAL RING ALLOGRAFT WAS BROKEN. IT IS UNKNOWN IF THERE IS PATIENT NOR PROCEDURE INVOLVEMENT. THIS REPORT IS FOR ONE (1) IMPLANT HOLDER-SLOT. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12315920 ↗

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.