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INSTRUMENT 2000-2000Recalls & reported problems

Howmedica Osteonics Corp. · STRYKER MODULAR IMPACTION HANDLE · 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
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613327241938), received between Mar 12, 2019 and Mar 12, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Degraded” (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

  • Degraded1

Patient problems

  • No Consequences Or Impact To Patient1

Recent adverse event reports

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

  • MalfunctionMar 12, 2019Degraded; Degraded

    IT WAS REPORTED THAT THE MODULAR IMPACT HANDLE WAS PREPARED BEFORE OPERATION, THERE WERE METAL PIECES THAT CAME OUT FROM THE IMPACT HANDLE. THE DEVICE WAS PURCHASED BY THE HOSPITAL IN (B)(6) 2018. THE DOCTOR INQUIRED, WHERE THE METAL PIECES WERE SCRAPED, HOW COULD SUCH AN EVENT HAVE OCCURRED.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8412078 ↗

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Sources and updates

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