BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHISEL

    MDR report key: 4102992 · Received September 19, 2014

    Report

    Report Number
    0002249697-2014-03578
    Event Type
    Malfunction
    Date Received
    September 19, 2014
    Date of Event
    August 29, 2014
    Report Date
    August 29, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MAY
    PMA / PMN Number
    K123604
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED WILL BE PROVIDED IN A SUPPLEMENTAL REPORT. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    REVIEW OF THE POST MARKET SURVEILLANCE SURVEY NOTED THAT, "BOX CHISEL DOES NOT REMOVE BONE, ONLY CUTS/TRACES BONE WHILE FAILING TO REMOVE. CURVED CURETTE IS GREAT! BROACH HANDLES ARE NICE FOR SMALL PATIENTS BUT LACK OFFSET FOR LARGER PATIENTS. WE DO NOT HAVE ACETABULAR INSTRUMENTS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    582475 CHISEL INSTRUMENT MAY STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other