BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GLENOID REAMER / PLANAR - 32MM

    MDR report key: 4221790 · Received November 3, 2014

    Report

    Report Number
    0002249697-2014-04152
    Event Type
    Malfunction
    Date Received
    November 3, 2014
    Date of Event
    October 10, 2014
    Report Date
    October 10, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    KWS
    PMA / PMN Number
    K130895
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS NOTED THAT THE DEVICE IS NOT AVAILABLE FOR EVALUATION DUE TO HOSPITAL POLICY. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION. NOT AVAILABLE.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING AN ASSEMBLY ISSUE BETWEEN AN RSA REAMER DRIVER AND RSA REAMER WAS REPORTED. THE EVENT WAS NOT CONFIRMED. METHOD & RESULTS: DEVICE EVALUATION AND RESULTS: NOT PERFORMED AS NO DEVICE WAS RETURNED FOR INSPECTION. 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 SIMILAR PREVIOUS REPORTED EVENTS. CONCLUSIONS: THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE THE DEVICE WAS NOT RETURNED FOR INSPECTION. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME. IF DEVICES BECOME AVAILABLE, THIS INVESTIGATION WILL BE REOPENED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE GUIDE PIN WOULD NOT FIT GUIDE (FOR GLENOSPHERE PREP). GLENOID REAMER DISENGAGED MANY TIMES WHILE REAMING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE GUIDE PIN WOULD NOT FIT GUIDE (FOR GLENOSPHERE PREP). GLENOID REAMER DISENGAGED MANY TIMES WHILE REAMING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    703704 GLENOID REAMER / PLANAR - 32MM INSTRUMENT KWS STRYKER ORTHOPAEDICS-MAHWAH ER8AA6

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Other