BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIZE 1-3 KEEL PUNCH

    MDR report key: 3092291 · Received May 3, 2013

    Report

    Report Number
    0002249697-2013-01522
    Event Type
    Malfunction
    Date Received
    May 3, 2013
    Date of Event
    April 11, 2013
    Report Date
    April 11, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    K123166
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WHEN COMPLETED, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING A FRACTURED TIBIAL KEEL PUNCH WAS REPORTED. THE EVENT WAS CONFIRMED. METHOD AND RESULTS: DEVICE EVALUATION AND RESULTS: A VISUAL INSPECTION CONFIRMED THE FRACTURE. MEDICAL RECORDS RECEIVED AND EVALUATION: NOT PERFORMED AS PATIENT FACTORS DID NOT CONTRIBUTE TO THE EVENT. DEVICE HISTORY REVIEW: ALL DEVICES ACCEPTED INTO FINAL STOCK CONFORMED TO SPECIFICATION. COMPLAINT HISTORY REVIEW: THERE HAVE BEEN NO SIMILAR PREVIOUS REPORTED EVENTS FOR THIS LOT ID. CONCLUSIONS: THE INVESTIGATION CONCLUDED THAT THE DEVICE BROKE AS A RESULT OF IN FAST FRACTURED OVERLOAD, CONSISTENT WITH REPEATED OFF-AXIS IMPACT. NO MATERIAL OR MANUFACTURING DEFECTS WERE IDENTIFIED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING SURGERY, THE PUNCH WAS INTEGRATED INTO THE BONE. WHEN THE HANDLE WAS LIFTED TO RELEASE, THE PUNCH ALREADY SNAPPED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING SURGERY, THE PUNCH WAS INTEGRATED INTO THE BONE. WHEN THE HANDLE WAS LIFTED TO RELEASE, THE PUNCH ALREADY SNAPPED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    195231 SIZE 1-3 KEEL PUNCH INSTRUMENT JWH STRYKER ORTHOPAEDICS-MAHWAH NYA03

    Patients

    Seq Age Sex Outcome Treatment
    1 Other