BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RSP SHOULDER

    MDR report key: 2854420 · Received November 29, 2012

    Report

    Report Number
    1644408-2012-00635
    Event Type
    Malfunction
    Date Received
    November 29, 2012
    Date of Event
    November 13, 2012
    Report Date
    November 13, 2012
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    KWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REASON FOR THIS FAILURE WAS DUE TO THE T HANDLE AND REMOVAL TOOL BOTH STRIPPING WHILE REMOVING THE GLENOSPHERE. THE DEVICES WERE INSPECTED PRIOR TO SURGERY AND ACCEPTED FOR SURGERY. THERE WAS A 20 MINUTE DELAY IN SURGERY AND ANOTHER SUITABLE DEVICE WAS AVAILABLE FOR USE. THE REVISION SURGERY WAS COMPLETED AS INTENDED. THE DEVICE WAS RETURNED TO DJO SURGICAL FOR EXAMINATION. A REVIEW OF THE DEVICE HISTORY RECORDS SHOWED NO NON-CONFORMING MATERIAL REPORTS ASSOCIATED WITH THE TAPER TESTER. THERE WAS ONE NON-CONFORMING MATERIAL REPORT ASSOCIATED WITH THE HEAD DISTRACTER ((B)(4)) FOR DISCOLORATION AND DAMAGED THREADS. THREE OF THE PARTS WERE RETURN TO VENDOR AND THE REMAINING PARTS WERE ACCEPTED AFTER INSPECTION/FUNCTIONAL CHECK. A REVIEW OF THE PRODUCT COMPLAINT REPORT HISTORY SHOWS THIS IS THE THIRD COMPLAINT FOR THIS PART NUMBER FOR SIMILAR DAMAGE, A FRACTURED GLENOID HEAD INSERTER, AND TAPER TESTER. THERE ARE FOUR COMPLAINTS FOR THE TIP BEING BENT AND ONE FOR THE THREAD STRIPPING IN THE HEAD DISTRACTOR. THE ROOT CAUSE FOR THE FAILURE CANNOT BE DETERMINED WITH CONFIDENCE, SINCE THE NUMBER OF INSTANCES THAT THE INSTRUMENTS WERE IN USE IS UNDETERMINED. THERE ARE NO INDICATIONS OF A PRODUCT OR PROCESS ISSUE AFFECTING IMPLANT SAFETY OR EFFECTIVENESS.

    Description of Event or Problem · 1

    INSTRUMENT FAILURE- THE LONG T HANDLE AND REMOVAL TOOL BOTH STRIPPED WHILE REMOVING THE GLENOSPHERE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RSP SHOULDER GLENOID HEAD INSERTER/IMPACTOR KWS ENCORE MEDICAL, L.P. 69077L03

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Other (B)(4), LOT 77737L01| (B)(4), LOT UNKNOWN