BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOLDING SLEEVE - LONG

    MDR report key: 2961446 · Received February 11, 2013

    Report

    Report Number
    1719045-2013-10049
    Event Type
    Malfunction
    Date Received
    February 11, 2013
    Date of Event
    January 14, 2011
    Report Date
    January 14, 2011
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURING RECORDS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE DEVICE WAS RECEIVED FOR INVESTIGATION. VISUAL INSPECTION OF THE INNER SLEEVE SHOWED HALF THE CIRCUMFERENCE OF THE MINOR DIAMETER OF THE 1ST-2ND THREAD WAS FRACTURED THROUGH TO THE INNER DIAMETER, AND PULLED SLIGHTLY AWAY, LEAVING A GAP. ALL DIMENSIONS MEASURED WERE WITHIN SPECIFICATIONS. MANUFACTURING EVALUATION REVEALED THAT THE THREADS WERE WITHIN SPECIFICATIONS. THE LOCATION OF THE FRACTURE INDICATED THAT THE SLEEVE BECAME LOOSE DURING SCREW INSERTION, WHICH COULD HAVE CONTRIBUTED TO THE BREAKAGE. THE EXACT ROOT CAUSE WAS INDETERMINATE. 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.

    Description of Event or Problem · 1

    PRIOR TO A TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF) PROCEDURE AT L4-L5 WITH MATRIX MIS SCREW FIXATION, THE TIP OF THE HOLDING SLEEVE BROKE. THE DEVICE WAS NOT USED IN THE PROCEDURE. ANOTHER HOLDING SLEEVE WAS USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    614576 HOLDING SLEEVE - LONG LXH SYNTHES MONUMENT 6280685

    Patients

    Seq Age Sex Outcome Treatment
    1