BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUP IMPACTOR BOLT

    MDR report key: 4241440 · Received November 10, 2014

    Report

    Report Number
    0002249697-2014-04217
    Event Type
    Malfunction
    Date Received
    November 10, 2014
    Date of Event
    October 16, 2014
    Report Date
    October 16, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MAY
    PMA / PMN Number
    K123604
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING DIFFICULTY DISASSEMBLING A DA IMPACTOR BOLT FROM A SHELL WAS REPORTED. THE EVENT WAS CONFIRMED. METHOD & RESULTS: -DEVICE EVALUATION AND RESULTS: A FUNCTION ANALYSIS CONFIRMED THE REPORTED DISASSEMBLY DIFFICULTY. INSPECTION OF THE DEVICE FOUND NO DAMAGE TO THE PRODUCT. IN ADDITION, NO MANUFACTURING NON-CONFORMANCES WERE IDENTIFIED. -MEDICAL RECORDS RECEIVED AND EVALUATION: NOT PERFORMED AS PATIENT FACTORS DID NOT CONTRIBUTE TO THE REPORTED EVENT. -DEVICE HISTORY REVIEW: ALL DEVICES ACCEPTED INTO FINAL STOCK CONFORMED TO SPECIFICATION. -COMPLAINT HISTORY REVIEW: THERE HAVE BEEN NO PREVIOUS REPORTED EVENTS FOR THIS LOT ID. CONCLUSIONS: IT WAS DETERMINED THAT NO MANUFACTURING NON-CONFORMITIES WERE IDENTIFIED. HOWEVER, THIS DEVICE IS IN SCOPE OF A NON-CONFORMANCE REPORT TO FURTHER INVESTIGATE THE ROOT CAUSE OF SIMILAR REPORTED EVENTS.

    Additional Manufacturer Narrative · 1

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT MAGNETIC DA NUT STUCK IN A PSL CUP.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT MAGNETIC DA NUT STUCK IN A PSL CUP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    722741 CUP IMPACTOR BOLT IMPLANT MAY STRYKER ORTHOPAEDICS-MAHWAH DC241824

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Other