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NA 419.98Recalls & reported problems

Synthes GmbH · WASHER 7.0MM · Class 2 · Implant

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982214829), received between Apr 23, 2021 and Apr 23, 2021 — classified as 1 injury.

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

  • Adverse Event Without Identified Device or Use Problem1

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.

  • InjuryApr 23, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT ON (B)(6) 2021, AN UNKNOWN HARDWARE REMOVAL PROCEDURE WAS PERFORMED FOR UNKNOWN REASON. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PATIENT OUTCOME WAS UNKNOWN. THIS COMPLAINT INVOLVES (13) DEVICES. THIS REPORT IS FOR (1) WASHER 7.0MM. THIS REPORT IS 11 OF 11 (B)(4). RELATED PRODUCT COMPLAINT: (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11718529 ↗

Other WASHER, BOLT NUT devices

All WASHER, BOLT NUT devices →

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