BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEM EXTRACTOR F/GUIDE BAR

    MDR report key: 3003410 · Received February 28, 2013

    Report

    Report Number
    8030965-2013-10430
    Event Type
    Malfunction
    Date Received
    February 28, 2013
    Date of Event
    June 9, 2011
    Report Date
    June 9, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWB
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEB 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFO RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE DEVICE WAS RECEIVED FOR EVAL. THE SET SCREW WAS NOT SENT BACK. VISUAL INSPECTION SHOWED THAT THERE WERE NO VISIBLE DAMAGES ON THE EXTRACTOR BODY. THE ROOT CAUSE COULD NOT BE DETERMINED AS THE BROKEN SET SCREW WAS NOT SENT BACK FOR INVESTIGATION.

    Description of Event or Problem · 1

    DURING REVISION SURGERY, AN ENTIRE EPOCA CONSTRUCT WAS REMOVED AND THE PT WAS REVISED TO DEPUY REVERSE TOTAL SHOULDER. WHILE REMOVING THE CONSTRUCT, THE SET SCREW ON THE STEM EXTRACTOR BROKE OFF. ALL BROKEN PIECES WERE RETRIEVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    86950 STEM EXTRACTOR F/GUIDE BAR HWB SYNTHES GMBH 09-6793

    Patients

    Seq Age Sex Outcome Treatment
    1