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TRIGEN 71692811Recalls & reported problems

Smith & Nephew, Inc. · 4.0mm SURESHOT LONG AO DRILL · Class 2

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 03596010648259), received between Apr 21, 2019 and Apr 21, 2019 — classified as 1 injury.

The most frequently reported specific device problem is “Material Fragmentation” (1 report).

1 other recall cover devices cleared under the same FDA submission (K100107); they may or may not involve this specific model.

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 Fragmentation1

Patient problems

  • Injury1

Recent adverse event reports

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

  • InjuryApr 21, 2019Material Fragmentation; Material Fragmentation

    IT WAS REPORTED THAT DURING SURGERY, DRILL BROKE AND THE HEAD OF THE DRILL WAS LEFT IN THE FEMORAL SHAFT MEDULLARY CAVITY.

    Patient problems: Injury

    MAUDE report 8534351 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K100107. One submission often covers many models, so check the product and lot details in each record.

  • Z-0411-2011 · Oct 15, 2010 · Terminated
    smith & nephew TRIGEN SURESHOT Distal Targeting System, Trauma Interface, V2.0.2, Trauma Launcher V1.01.1 Product is intended to be an intraoperative image-guided localization syst

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