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INSTRUMENT 6541-4-810Recalls & reported problems

Howmedica Osteonics Corp. · IMPACTION HANDLE TRIATHLON INSTRUMENTS · Class 1

All models of INSTRUMENT (131)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

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 07613327240603), received between Dec 4, 2019 and Dec 4, 2019 — classified as 1 injury.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Device problems

  • Detachment of Device or Device Component1

Patient problems

  • Foreign Body In Patient1
  • Injury1

Recent adverse event reports

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

  • InjuryDec 4, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

    DURING THE TKA PROCEDURE, A METAL PLUG FELL OUT OF THE PATIENT'S BODY FROM THE TRIATHLON 6541-4-810 HANDLE. ONE YEAR AFTER THE SURGERY, THE PATIENT WAS REFERRED FOR ANOTHER SURGERY TO REMOVE THE PART FROM THE TRIATHLON HANDLE. PHOTOS ATTACHED. UPDATE: THE PLUG CUT WAS NOT INTO THE INSERT. THE INSERT WAS REVISED AS A STANDARD PROCEDURE. LEFT SIDE.

    Patient problems: Foreign Body In Patient; Injury

    MAUDE report 9412259 ↗

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Sources and updates

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