BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TIBIAL RESECTION GUIDE MODULAR CAPTURE RT

    MDR report key: 3113527 · Received May 15, 2013

    Report

    Report Number
    0002249697-2013-01680
    Event Type
    Malfunction
    Date Received
    May 15, 2013
    Date of Event
    April 30, 2013
    Report Date
    April 30, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    K123166
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    NURSE

    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 LOOSE TRIATHLON CAPTURE WAS REPORTED. THE EVENT WAS NOT CONFIRMED. DEVICE EVALUATION NOT PERFORMED AS NO DEVICE WAS RETURNED FOR INSPECTION. MEDICAL RECORDS EVALUATION NOT PERFORMED AS NO PATIENT INVOLVEMENT WAS REPORTED. DEVICE HISTORY REVIEW NOT PERFORMED AS NO LOT ID WAS PROVIDED FOR REVIEW. COMPLAINT HISTORY REVIEW NOT PERFORMED AS NO LOT ID WAS PROVIDED FOR REVIEW. THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE THE REPORTED DEVICE WAS NOT RETURNED FOR INSPECTION. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME. IF THE DEVICE BECOMES AVAILABLE, THIS INVESTIGATION WILL BE REOPENED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PIECE OF THE REPORTED DEVICE HAS COME LOOSENED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PIECE OF THE REPORTED DEVICE HAS COME LOOSENED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    215854 TIBIAL RESECTION GUIDE MODULAR CAPTURE RT INSTRUMENT JWH STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other