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TRIGEN 71691153Recalls & reported problems

Smith & Nephew, Inc. · SURESHOT HUMERAL 3.5MM HEXDRIVER · Class 2

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 03596010656643), received between Sep 21, 2020 and Sep 21, 2020 — 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.

  • MalfunctionSep 21, 2020Break; Break

    IT WAS REPORTED THAT PRIOR TO SURGERY, DURING INSTRUMENT INSPECTION WAS NOTICED THAT THE SURESHOT HUMERAL 3.5MM HEXDRIVER IS BROKEN. THE PROCEDURE WAS COMPLETED USING A SMITH AND NEPHEW BACK UP DEVICE, WITH NO SURGICAL DELAY. THERE WAS NO PATIENT INVOLVED WHEN THE ISSUE WAS IDENTIFIED.

    Patient problems: No Patient Involvement

    MAUDE report 10558426 ↗

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