BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOLDING SLEEVE-LONG

    MDR report key: 3003488 · Received February 28, 2013

    Report

    Report Number
    1719045-2013-10229
    Event Type
    Malfunction
    Date Received
    February 28, 2013
    Report Date
    May 4, 2011
    Manufacturer
    SYNTHES (USA)
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. THE SAMPLE WAS RECEIVED WITH THE FIRST THREAD BROKEN AT THE MINOR DIAMETER. HALF OF THE FIRST THREAD REMAINS ON THE TIP. MINOR SCRATCHES LOCATED ON THE SHAFT ARE INDICATIVE OF USAGE. MFG INVESTIGATION CONCLUDED THE HARDNESS VALUE AND THE SHAFT ID COULD NOT BE MEASURED DUE TO DAMAGES. MEASURABLE FEATURES WERE FOUND WITHIN SPEC. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT SHOW CONDITIONS THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. PRODUCT DEVELOPMENT INVESTIGATION REVEALS THAT THE CHIPPING OF THE TIP INDICATES THE DAMAGED OCCURRED AS A RESULT OF IMPROPER HANDLING. THE ORIGIN OF THE DEFECT REMAINS UNK AND THE DEVICE WAS DAMAGED DURING THE CLEANING AND STERILIZATION PROCESS. THE COMPLAINT IS THEREFORE INDETERMINATE FROM A MFG PERSPECTIVE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ITEMS WERE INSPECTED AFTER A LUMBAR FUSION SURGERY/STERILIZATION AND IT WAS FOUND THE HOLDING SLEEVE LONG IS CHIPPED OFF AT THE END. HOW AND WHEN THE SLEEVE CHIPPED IS UNK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    87020 HOLDING SLEEVE-LONG LXH SYNTHES (USA) 6490071

    Patients

    Seq Age Sex Outcome Treatment
    1