BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNFIX MINI-OPEN IMPLANT COUPLING

    MDR report key: 2893940 · Received January 3, 2013

    Report

    Report Number
    1719045-2013-00005
    Event Type
    Malfunction
    Date Received
    January 3, 2013
    Date of Event
    December 5, 2012
    Report Date
    December 5, 2012
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    MAX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. VISUAL INSPECTIONS NOTED THE TIP I S BROKEN OFF THE SHAFT. THE THREADED TIP EXHIBITS MINOR DAMAGE TO THE THREADS AND SCUFF MARKS. THERE ARE MINOR SCUFF MARKS ALONG THE SHAFT AND KNOB. NEMCOMED (PRESENTLY AVALIGN - NEMCOMED) MANUFACTURED THE SYNFIX MINI-OPEN IMPLANT COUPLING, LOT # 6236633 (SUPPLIER LOT # 78840). THE COMPLAINT CONDITION IS DUE TO AN UNKNOWN CAUSE. DIMENSIONS THAT COULD BE MEASURED WERE FOUND TO MEET SPECIFICATIONS. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO COMPLAINT RELATED ANOMALIES.

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. THE DISTAL TIP SHEARED OFF AT THE SMALLEST CROSS SECTION. THE RETURN INCLUDED THE LIBERATED THREADED PIECE. THE OTHER CRITICAL SURFACES ARE IN EXCELLENT CONDITION. THIS PART FAILED IN TORSION DUE TO STRESSES BEYOND THE ULTIMATE STRENGTH OF THE PART. THE MOST LIKELY CAUSE FOR THIS COMPLAINT IS OVER TIGHTENING THE HANDLE AGAINST THE PLATE OF THE IMPLANT. THE RISK ANALYSIS ADEQUATELY ADDRESSES THE HAZARD OF THE COMPLAINT.

    Description of Event or Problem · 1

    DURING AN L5-S1 ALIF PROCEDURE THE SURGEON USED THE SYNFIX MINI IMPLANT COUPLING IN WHICH THE TIP OF THE INSTRUMENT BROKE INTRAOPERATIVELY AFTER THE LAST SCREW WAS IMPLANTED. THE SURGEON RETRIEVED THE ONE QUARTER INCH PIECE FROM THE OPERATIVE SITE WITH A HEMOSTAT. NO DELAY OR INJURY TO THE PATIENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2725 SYNFIX MINI-OPEN IMPLANT COUPLING SYNFIX MINI-OPEN IMPLANT COUPLING MAX SYNTHES MONUMENT 78840

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR