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ENDOBUTTON 72202073Recalls & reported problems

Smith & Nephew, Inc. · MTO ENDOBUTTON TWINBRIDGE FIX DEVICE · Class 2 · Implant

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 03596010652898), received between Oct 7, 2019 and Oct 7, 2019 — classified as 1 malfunction.

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 Known Impact Or Consequence To Patient1

Recent adverse event reports

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

  • MalfunctionOct 7, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT, AFTER AN ARTHROSCOPIC AC REPAIR SURGERY IN WHICH AN ENDOBUTTON TWINBRIDGE WAS USED, UPON 6-MONTH REVISION WAS FOUND THAT THE DEVICE PROBABLY FAILED. EVEN THOUGH THE PATIENT HAS NOT MANIFESTED ANY SYMPTOM YET, THE X-RAY EXAMINATION SHOWS THAT THE PATIENT HAS AC DISLOCATION AGAIN, SO IT IS BELIEVED THAT THE DEVICE WIRES BROKE. IT IS STILL UNKNOWN WHAT REMEDIAL ACTION WILL BE TAKEN UPON THIS FINDING. THE PATIENT WAS NOT STATED TO BE INJURED.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 9163097 ↗

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.