BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIGLIANI/FLATOW GLENOID INSTRUMENT

    MDR report key: 1950065 · Received December 7, 2010

    Report

    Report Number
    1822565-2010-01299
    Event Type
    Malfunction
    Date Received
    December 7, 2010
    Date of Event
    October 28, 2010
    Report Date
    October 28, 2010
    Manufacturer
    ZIMMER, INC.
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: BREAKAGE MIGHT HAVE BEEN CAUSED DUE TO APPLICATION OF HIGH TORQUE ALONG WITH BENDING/DEFLECTION DURING ITS USE. NO PRODUCT WAS RETURNED. THE EXACT CAUSE ANALYSIS CANNOT BE DETERMINED WITH CERTAINTY. EVAL: REVIEW OF THE DEVICE HISTORY RECORDS WAS NOT POSSIBLE AS THE PRODUCT AND/OR LOT NUMBERS REQUIRED FOR RETRIEVAL WERE UNAVAILABLE. IT IS NOT SUSPECTED THAT THE PRODUCT FAILED TO MEET SPECIFICATIONS. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY EVIDENCE OF PRODUCT CONTRIBUTION TO THE REPORTED PROBLEM. BASED ON THE AVAILABLE INFO, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. SHOULD ADD'L SUBSTANTIVE INFO BE RECEIVED, THE COMPLAINT WILL BE REOPENED. ZIMMER, INC CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PATIENT'S BONE WAS VERY HARD AND THAT THE SURGEON HAD TO DRILL FOR ROUGHLY 20 SECONDS IN ORDER TO ACHIEVE PROPER DEPTH. POST-OPERATIVE X-RAYS SHOW THAT THE TIP OF THE PIN WAS BROKEN OFF AND WAS LEFT IN THE GLENOID.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIGLIANI/FLATOW GLENOID INSTRUMENT SHOULDER INSTRUMENT LXH ZIMMER, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR