BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TORQUE LIMITING 2.5MM HEX DRIVER, T-HANDLE

    MDR report key: 1051323 · Received May 22, 2008

    Report

    Report Number
    3004142400-2008-00004
    Event Type
    Malfunction
    Date Received
    May 22, 2008
    Date of Event
    April 22, 2008
    Report Date
    May 22, 2008
    Manufacturer
    GLOBUS MEDICAL, INC.
    Product Code
    HXX
    PMA / PMN Number
    K061202
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A COMPREHENSIVE INVESTIGATION WAS IMMEDIATELY INITIATED ON RECEIPT OF THE REPORT. A COMPREHENSIVE REVIEW WAS CONDUCTED OF ALL APPLICABLE MATERIAL RECORDS, MANUFACTURING RECORDS, STORAGE RECORDS, AND DISTRIBUTION RECORDS. ALL RECORDS REVEALED THE PRODUCTS WERE MANUFACTURED WITHIN SPECIFICATIONS, MAINTAINED AND DISTRIBUTED IN ACCORDANCE WITH ALL FEDERAL, STATE AND OPERATING PROCEDURES. THE DRIVER IS SNAPPED OFF AT THE TRANSITION BETWEEN THE HEX AND THE SHAFT AND IS A CLEAN BREAK, SHOWING LITTLE TO NO EVIDENCE OF TWISTING OF THE HEX PRIOR TO BREAKING. OTHERWISE, THE INSTRUMENT IS IN GOOD CONDITION. THIS TYPE OF BREAK IS NOT CONSISTENT WITH A TYPICAL PURE TORSIONAL FAILURE IN THE HEX, WHICH WOULD SHOW SOME TWISTING OF THE HEX EDGES AND A SPIRALED, RATHER THAN CLEAN, FLAT BREAK. THIS TYPE OF BREAK TYPICALLY OCCURS WHEN THE SHAFT IS EXPOSED TO EXCESSIVE FLEX, CAUSING THE SHAFT TO SNAP AT THE WEAKEST POINT. WHEN SUBJECTED TO LATERAL FORCES, THERE IS A POSSIBILITY FOR THIS CONDITION TO OCCUR. HOWEVER, THE DRIVERS WERE NOT DESIGNED WITH THIS INTENTION; THEY SHOULD ONLY BE SUBJECTED TO AXIAL FORCE TO DRIVE THE SET SCREW INTO THE CROSS CONNECTOR. BASED ON RECORD REVIEW AND ALL AVAILABLE INFORMATION, IT WAS DETERMINED THAT THE TORQUE LIMITING, HEX DRIVER CONFORMS TO ALL APPLICABLE STANDARDS AND THERE WAS NO DEVIATION IN THE MANUFACTURE PROCESS.

    Description of Event or Problem · 1

    GLOBUS MEDICAL RECEIVED NOTIFICATION FROM A DISTRIBUTOR, VIA A COMPANY PROCESSING/EVALUATION FORM, THAT A GLOBUS MANUFACTURED HEX DRIVER TIP HAD BROKEN OFF IN A CROSSLINK SET SCREW DURING SURGERY. THE ONLY INFORMATION PROVIDED WAS THAT THE TORQUE LIMITING 2.5MM HEX DRIVER, TIP BROKE OFF IN CROSSLINK SET SCREW DURING SURGERY. THE TIP OF THE DRIVER REMAINED IN THE CROSSLINK WHICH IS STILL IN THE PATIENT. THE BROKEN DRIVER WAS RETURNED TO GLOBUS MEDICAL FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TORQUE LIMITING 2.5MM HEX DRIVER, T-HANDLE HEX DRIVER HXX GLOBUS MEDICAL, INC. 602.430 BRG079AC

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention