BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    X-MESH INSERTER/EXPANDER

    MDR report key: 3162418 · Received June 11, 2013

    Report

    Report Number
    1526439-2013-18600
    Event Type
    Malfunction
    Date Received
    June 11, 2013
    Date of Event
    May 20, 2013
    Report Date
    May 20, 2013
    Manufacturer
    DEPUY SYNTHES SPINE
    Product Code
    LXH
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A FOLLOW UP REPORT WILL BE FILED UPON RECEIPT OF THE INSTRUMENT AND COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    VISUAL INSPECTION OF THE X-MESH INSERTER/EXPANDER NOTED THAT THE PIN ON THE TIP OF THE ARM SUB ASSEMBLY WAS BROKEN OFF. NO OTHER VISUAL ANOMALIES WERE NOTED DURING THE INSPECTION. REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DISCREPANCIES. A REVIEW OF THE COMPLAINT TREND ANALYSIS FOUND NO RELATED COMPLAINTS FOR THIS PRODUCTION LOT. ALTHOUGH NO DEFINITIVE CONCLUSIONS CAN BE MADE, EXAMINATION OF THE RETURNED INSTRUMENT BY QUALITY ENGINEERING HAS DETERMINED THAT THE MOST LIKELY CAUSE OF THE TIP BREAKAGE WAS AN UNANTICIPATED IMPACT FORCE, RESULTING IN TIP SEPARATION. IN THE ABSENCE OF AN IDENTIFIED DEVICE MANUFACTURING/RELEASE ISSUE OR AN OBSERVED TREND, THIS COMPLAINT WILL BE CLOSED WITH NO FURTHER ACTION REQUIRED.

    Description of Event or Problem · 1

    INTERNATIONAL AFFILIATE REPORTS THAT RETURNED LOAN KIT INSPECTION FOUND A PIN ON THE DISTAL TIP OF THE X-MESH INSERTER/EXPANDER HAD BROKEN OFF FROM THE INSTRUMENT. IT IS NOT KNOWN WHEN OR WHERE TIP BREAKAGE OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    262066 X-MESH INSERTER/EXPANDER ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH DEPUY SYNTHES SPINE BR0908

    Patients

    Seq Age Sex Outcome Treatment
    1