BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1/8" PEG DRILL

    MDR report key: 4090568 · Received September 15, 2014

    Report

    Report Number
    0002249697-2014-03470
    Event Type
    Malfunction
    Date Received
    September 15, 2014
    Date of Event
    August 21, 2014
    Report Date
    August 21, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MBH
    PMA / PMN Number
    K123486
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WHEN COMPLETED, THE INVESTIGATION RESULTS WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING A FRACTURED TRIATHLON 1/8" PEG DRILL WAS REPORTED. THE EVENT WAS CONFIRMED. METHOD & RESULTS: -DEVICE EVALUATION AND RESULTS: VISUAL INSPECTION CONFIRMED THE REPORTED FRACTURE. A MATERIAL ANALYSIS INDICATED THE DRILL BIT FRACTURE OCCURRED IN MIXED-MODE OVERLOAD AND DUCTILE OVERLOAD WHILE IN RIGHT-HANDED ROTATION. -MEDICAL RECORDS RECEIVED AND EVALUATION: NOT PERFORMED AS THERE IS NO INDICATION PATIENT FACTORS CONTRIBUTED TO THE REPORTED EVENT. -DEVICE HISTORY REVIEW: THE REPORTED DEVICE WAS MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. -COMPLAINT HISTORY REVIEW: THERE HAS BEEN ONE OTHER SIMILAR EVENTS REPORTED FOR THIS MANUFACTURING LOT. CONCLUSIONS: THE EVENT WAS CONFIRMED, THE DRILL BIT FRACTURED. A MATERIAL ANALYSIS INDICATED THE DRILL BIT FRACTURE OCCURRED IN MIXED-MODE OVERLOAD AND DUCTILE OVERLOAD WHILE IN RIGHT-HANDED ROTATION.

    Description of Event or Problem · 1

    DRILL BIT BROKE DURING USE.

    Description of Event or Problem · 1

    DRILL BIT BROKE DURING USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    569601 1/8" PEG DRILL INSTRUMENT MBH STRYKER ORTHOPAEDICS-MAHWAH SC4C07

    Patients

    Seq Age Sex Outcome Treatment
    1 Other