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HIP Instruments 01.15.10.0133Recalls & reported problems

Medacta International SA · Straight AMIS Broach Handle · Class 1

All models of Hip Instruments (48)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
2
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07630040735254), received between Sep 5, 2019 and Sep 5, 2019 — classified as 1 injury, 1 malfunction.

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 18, 2026.

Most reported problems

Device problems

  • Detachment of Device or Device Component1
  • Device Fell1

Patient problems

  • No Known Impact Or Consequence To Patient2

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • MalfunctionSep 5, 2019Device Fell

    DURING THE FEMORAL RASPING, WHEN THE SURGEON PULL OUT THE STRAIGHT AMIS BROACH HANDLE WITH A HAMMER, THE REVER DISENGAGED AND FELL IN THE SURGICAL FIELD. THE SURGEON REMOVED THE BROACH FROM THE MEDULLARY CAVITY WITH ANOTHER INSTRUMENT. DUE TO THIS EVENT THE SURGERY WAS PROLONGED ABOUT 10 MINUTES.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 8964797 ↗
  • InjurySep 5, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

    WHEN THE SURGEON TRIED TO REMOVE THE BROACH FROM THE MEDULLARY CAVITY WITH THE STRAIGHT AMIS BROACH HANDLE, THE LEVER DISENGAGED FROM THE STRAIGHT AMIS BROACH HANDLE. SEVERAL PARTS DISASSEMBLED AND SOME WERE FELL INTO THE SURGICAL FIELD. ALL OF THEM WERE ABLE TO RETRIEVE. THE SURGEON REMOVED THE BROACH FROM THE MEDULLARY CAVITY WITH ANOTHER INSTRUMENT. DUE TO THIS EVENT, THE SURGERY WAS PROLONGED ABOUT 10 MINUTES.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 8964687 ↗

Other Orthopedic Manual Surgical Instrument devices

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Sources and updates

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