BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOCKING HOLDING SLEEVE- STANDARD FOR MATRIX

    MDR report key: 2850270 · Received November 29, 2012

    Report

    Report Number
    1719045-2012-01206
    Event Type
    Malfunction
    Date Received
    November 29, 2012
    Date of Event
    November 2, 2012
    Report Date
    November 2, 2012
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. A DEVICE HISTORY RECORD REVIEW WAS CONDUCTED. THE CERTIFICATE OF COMPLIANCE INDICATES THE PARTS WERE MANUFACTURED ACCORDING TO THE TABULATED DRAWING. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. THE BROKEN THREAD LOCATION INDICATES THAT THE ENGAGED HOLDING SLEEVE WAS PARTIALLY UNTHREADED FROM THE IMPLANT INTERFACE, AT WHICH POINT A CANTILEVER LOAD WAS APPLIED TO ASSEMBLY. THE MATRIX TECHNIQUE DESCRIBES THE PROPER WAY OF LOADING AND UNLOADING THE SCREWS ON THE HOLDING SLEEVE. THE DESIGN RISK ASSESSMENT WAS REVIEWED AND WAS FOUND TO BE ADEQUATE FOR THE INTENDED USE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED REGARDING AN L4-5 DECOMPRESSION AND INTERBODY FUSION PROCEDURE. WHILE THE SURGEON WAS INSERTING THE FIRST PEDICLE SCREW, THE SCREWDRIVER DISENGAGED HALFWAY THROUGH THE SCREW INSERTION. IT WAS OBSERVED THAT THE TIP OF THE HOLDING SLEEVE WAS DEFORMED AND THE THREADS OF THE PART WERE SHREDDED. SUBSEQUENTLY, THE SCREW WAS COMPLETELY SEATED USING A REPLACEMENT T-HANDLE SCREWDRIVER. FLUOROSCOPY WAS TAKEN INTRAOPERATIVELY AND REVEALED NO EVIDENCE OF FOREIGN BODIES. THE IMPLANTATION WAS COMPLETED WITH NO FURTHER ISSUES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LOCKING HOLDING SLEEVE- STANDARD FOR MATRIX LOCKING HOLDING SLEEVE LXH SYNTHES MONUMENT 6839777

    Patients

    Seq Age Sex Outcome Treatment
    1