BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PIN PULLER

    MDR report key: 3213510 · Received July 9, 2013

    Report

    Report Number
    0002249697-2013-02229
    Event Type
    Malfunction
    Date Received
    July 9, 2013
    Date of Event
    June 10, 2013
    Report Date
    June 11, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MBH
    PMA / PMN Number
    K123486
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    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 PIN PULLER NOT HOLDING PINS WAS REPORTED. THE EVENT WAS CONFIRMED. VISUAL ANALYSIS OF THE RETURNED DEVICE SHOWED THE PIN THAT HELD THE ARM AND HANDLE OF THE PIN PULLER TOGETHER HAD FRACTURED. THE INNOMED SUPPLIER INVESTIGATION DETERMINED THAT THE PIN FRACTURED DUE TO EXCESSIVE FORCE BY THE USER. A DEVICE HISTORY REVIEW INDICATED THAT ALL DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. A COMPLAINT HISTORY REVIEW INDICATED THAT THERE HAVE BEEN NO SIMILAR EVENTS FOR THE REPORTED LOT. THE INVESTIGATION CONCLUDED THAT PIN FRACTURING IN THE PIN PULLER WAS CAUSED BY EXCESSIVE FORCE BY THE USER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE SURGERY, HEADLESS PIN HOLDER STARTED TO NOT HOLD THE PINS. SURGERY WAS COMPLETED WITH A SURGICAL PLIERS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE SURGERY, HEADLESS PIN HOLDER STARTED TO NOT HOLD THE PINS. SURGERY WAS COMPLETED WITH A SURGICAL PLIERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311962 PIN PULLER INSTRUMENT MBH STRYKER ORTHOPAEDICS-MAHWAH AY4K01

    Patients

    Seq Age Sex Outcome Treatment
    1 Other