BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4.5 MM TAP (STAINLESS STEEL)

    MDR report key: 5078777 · Received September 15, 2015

    Report

    Report Number
    2027467-2015-00181
    Event Type
    Malfunction
    Date Received
    September 15, 2015
    Date of Event
    August 26, 2015
    Report Date
    August 26, 2015
    Manufacturer
    ALPHATEC SPINE INC
    Product Code
    HWX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL INSPECTION OF THE RETURNED INSTRUMENT FOUND IT HAD FRACTURED AND SEPARATED AT THE 60MM DEPTH GROVE INDICATOR. BOTH SECTIONS OF THE DEVICE WERE RETURNED. THE PATIENT DID NOT RETAIN A FOREIGN BODY. A PREVIOUS INVESTIGATION FOR THIS TYPE OF EVENT FOUND THE DESIGN OF FLUTE DEPTH AND GEOMETRY, AS WELL AS EPOXY GROOVE GEOMETRY WAS INAPPROPRIATE FOR THIS APPLICATION. CONTRIBUTING FACTORS INCLUDE SURGICAL TECHNIQUE AND MISUSE, PATIENT BONE QUALITY, IMPROPER MEASUREMENT TECHNIQUE OF THE FLUTES. AN UPDATE OF THE DIMENSIONS AND MATERIAL OF THE ARSENAL TAPS AND HAS BEEN IMPLEMENTED TO REDUCE THIS TYPE OF EVENT. ADDITIONALLY, FURTHER INVESTIGATION ON IMPROVING INSPECTION METHODS IN COLLABORATION WITH VENDOR HAS IDENTIFIED POTENTIAL FOR SIGNIFICANT IMPROVEMENT IN INSPECTION METHOD. CURRENT ACCEPTED INSPECTION PROCESS IS IN PLACE.

    Description of Event or Problem · 1

    DURING PEDICLE PREPARATION, AN ARSENAL 4.5MM TAP BENT AND THEN BROKE. THE SURGEON WAS ABLE TO RETRIEVE THE DISTAL END OF THE TAP FROM THE PATIENT'S PEDICLE WITH THE AID OF A NEEDLE DRIVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    609692 4.5 MM TAP (STAINLESS STEEL) HWX HWX ALPHATEC SPINE INC 87007-045 7404901

    Patients

    Seq Age Sex Outcome Treatment
    1 Other