BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REFORM POLYAXIAL DRIVER

    MDR report key: 3522376 · Received November 15, 2013

    Report

    Report Number
    3005739886-2013-00045
    Event Type
    Injury
    Date Received
    November 15, 2013
    Date of Event
    October 15, 2013
    Report Date
    October 21, 2013
    Manufacturer
    SPINAL USA INC
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED EVENT INVOLVES THE FAILURE OF TWO (2) DRIVERS FROM THE SAME LOT. ONLY ONE REPORT IS BEING FILED TO INCLUDE EVALUATION OF BOTH DRIVERS. EVALUATION OF THE RETURNED DRIVERS WAS NOT PERFORMED AS THE FAILURE MODE WAS IDENTIFIED IN A PREVIOUS INVESTIGATION. THE DRIVERS FAILED UNDER BRITTLE MATERIAL CIRCUMSTANCES. REVIEW OF RECEIVING INSPECTION REPORTS FOR THIS LOT FOUND THAT A TOTAL OF FIFTY-FOUR (54) DRIVERS WERE RECEIVED FROM THE SUPPLIER AND RELEASED FOR DISTRIBUTION IN (B)(4) OF 2013 WITH NO DEVIATION OR ANOMALIES. REVIEW OF COMPLAINT HISTORY FOUND A TOTAL OF THREE (3) REPORTS FOR FRACTURED TIPS FOR THIS LOT/DESIGN REVISION. ONE OF WHICH WAS REPORTED TO HAVE OCCURED WHEN THE DRIVER WAS DROPPED ON THE FLOOR DURING CLEANING PROCESS, NOT DURING A PROCEDURE. A CAPA WAS INITIATED, WHICH IDENTIFIED THE ROOT CAUSE TO BE ATTRIBUTED TO THE MATERIAL USED BEING TOO BRITTLE CAUSING PREMATURE FAILURE. CORRECTIVE ACTIONS WERE INITIATED TO CHANGE TO A LESS BRITTLE MATERIAL AND TO ADD A FILLET BETWEEN THE HEXALOBULAR TIP AND THE DRIVER SHAFT TO INCREASE STRESS RELIEF AT THOSE MECHANICAL INTERFACES. A HEALTH HAZARD EVALUATION WAS PERFORMED, DETERMINING A NON/NEGLIGABLE HEALTH RISK. IT WAS DETERMINED THAT A STOCK RECOVERY WOULD BE INITIATED FOR THIS LOT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE PERFORMED BY DR. ON (B)(6) 2013, THE TIP OF TWO REFORM POLYAXIAL DRIVERS FRACTURED IN THE HEAD OF THE POYAXIAL SCREW. BOTH SCREWS WERE REMOVED AND REPLACED WITH NEW SCREWS USING AN ALTERNATE DRIVER AVAILABLE IN THE SET. THIS RESULTED IN A DELAY TO PROCEDURE OF APPROXIMATELY TWENTY (20) MINUTES. NO INJURY TO THE PATIENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    594170 REFORM POLYAXIAL DRIVER SCREWDRIVER LXH SPINAL USA INC 3144MM

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention