BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MOSS MIAMI FINAL TIGHTENER

    MDR report key: 3021434 · Received March 26, 2013

    Report

    Report Number
    1526439-2013-14451
    Event Type
    Malfunction
    Date Received
    March 26, 2013
    Date of Event
    March 4, 2013
    Report Date
    May 22, 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 DEVICE AND COMPLETION OF THE EVALUATION.

    Additional Manufacturer Narrative · 1

    VISUAL INSPECTION FOUND THE DRIVER TIP HAD SHEARED OFF FROM THE INSTRUMENT. REVIEW OF THE DEVICE HISTORY RECORD IDENTIFIED NO ISSUES DURING THE MANUFACTURING AND RELEASE OF THIS PRODUCT THAT COULD BE ATTRIBUTED TO THE PROBLEM REPORTED BY THE CUSTOMER. THE PRODUCT WAS RELEASED ACCOMPLISHING ALL QUALITY REQUIREMENTS. THE CAUSE OF TIP BREAKAGE CANNOT BE POSITIVELY DETERMINED. HOWEVER, SCANNING ELECTRON MICROSCOPY ANALYSIS NOTED PLASTIC DEFORMATION AT THE HEX LOBES, INDICATING A TORSIONAL OVERLOAD. AT THIS TIME, THE COMPLAINT IS CONSIDERED TO BE CLOSED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TIP OF THE FINAL TIGHTENER BROKE OFF FROM THE INSTRUMENT DURING SET SCREW TIGHTENING. THE BROKEN TIP WAS RETRIEVED FROM THE SURGICAL SITE AND WAS DISCARDED BY THE CUSTOMER. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT AND NO RESULTING DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123087 MOSS MIAMI FINAL TIGHTENER ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH DEPUY SYNTHES SPINE GM3723801

    Patients

    Seq Age Sex Outcome Treatment
    1