BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HELICAL BLADE INSERTER

    MDR report key: 3003478 · Received February 28, 2013

    Report

    Report Number
    3003787298-2013-10038
    Event Type
    Malfunction
    Date Received
    February 28, 2013
    Report Date
    June 16, 2011
    Manufacturer
    SYNTHES JENNERSVILLE
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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 FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADD'L INFO REC'D REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. THE DHR WAS REVIEWED AND NO ISSUES THAT WOULD HAVE RESULTED IN THIS COMPLAINT WERE FOUND. THE MFG EVAL EVALUATED THE NONCOMFORMANCE AND ACCEPTED USE AS IS BECAUSE THE UNDERSIZE CONDITION OF THE RAW MATERIAL DOES NOT AFFECT THE FINISHED PART QUALITY. THE PRODUCT DEVELOPMENT VISUAL INSPECTION REVEALED NICKS, SCRATCHES AND WEAR ON THE GOLD HANDLE AND ON THE SHAFT. THE PRODUCT INVESTIGATION REVEALED THE COMPLAINT TO BE INDETERMINATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SET SCREW AT THE TOP OF THE HELICAL BLADE INSERTER. THE SURGEON WAS ABLE TO FINISH THE PROCEDURE W/O ANY HARM TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    85846 HELICAL BLADE INSERTER LXH SYNTHES JENNERSVILLE 4729333

    Patients

    Seq Age Sex Outcome Treatment
    1