BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DHS/DC COUPLING SCREW

    MDR report key: 3003534 · Received February 28, 2013

    Report

    Report Number
    3003787298-2013-10022
    Event Type
    Malfunction
    Date Received
    February 28, 2013
    Date of Event
    March 10, 2011
    Report Date
    March 10, 2011
    Manufacturer
    SYNTHES JENNERSVILLE
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    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 ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. THE SAMPLE WAS RECEIVED AND VISUAL INSPECTION NOTED THE THREADED PORTION OF THE INSTRUMENT BROKEN OFF AT THE TRANSITION OF THE THREADED PORTION AND THE NON-THREADED PORTION. PROCESS TESTING PERFORMED ON RELEVANT FEATURES DID NOT REVEAL ISSUES. DUE TO THE NOTED DAMAGE, EVALUATION ON ALL FEATURES COULD NOT BE COMPLETED. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT SHOW CONDITIONS THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. THE COMPLAINT IS INDETERMINATE FROM A MANUFACTURING PERSPECTIVE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE THE DHS/DCS THE TIP OF THE COUPLING SCREW BROKE. THE PIECE WAS RETRIEVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    87167 DHS/DC COUPLING SCREW LXH SYNTHES JENNERSVILLE 5891449

    Patients

    Seq Age Sex Outcome Treatment
    1