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INSTRUMENT 0580-3744-0Recalls & reported problems

Howmedica Osteonics Corp. · EXETER MODULAR RASP · Class 2

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 07613327207705), received between Jun 19, 2018 and Jun 19, 2018 — classified as 1 injury.

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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Device problems

  • Break1
  • Fracture1
  • Mechanical Jam1

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.

  • InjuryJun 19, 2018Break; Fracture; Mechanical Jam; Break; Fracture; Mechanical Jam

    NIB OF EXETER MODULAR BROACH (44 #0) BROKE OFF WHILE BROACH WHEN TRYING TO REMOVE A FULLY INSERTED INTO FEMUR. BROACH COULD NOT BE REMOVED FROM PATIENTS FEMUR USING EXETER BROACH HANDLE. VARIOUS METHODS OF REMOVAL WERE TRIED BY SURGEON BEFORE BROACH WAS REMOVED AFTER BURRING A HOLE INTO THE PROXIMAL END AND A SLAP HAMMER WITH A SMALL HOOK ATTACHMENT WAS INSERTED TO BACKSLAP IT OUT. APPROXIMATELY 90MINS ADDED TO PROCEDURE TO REMOVE INSTRUMENT BEFORE SURGERY COULD BE CONTINUED AND COMPLETED.

    Patient problems: Injury

    MAUDE report 7616569 ↗

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Sources and updates

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