BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4.5MM TAP (STAINLESS STEEL)

    MDR report key: 4903868 · Received July 9, 2015

    Report

    Report Number
    2027467-2015-00122
    Event Type
    Malfunction
    Date Received
    July 9, 2015
    Date of Event
    August 21, 2014
    Report Date
    June 12, 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

    MDR BEING SUBMITTED AS A RESULT OF A RETROSPECTIVE COMPLAINT REVIEW. ALTHOUGH THE USER FACILITY DISCARD THE INSTRUMENT IN QUESTION, 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

    THE SURGEON PREFERS TO UNDER TAP BY 1 MM. HE TAPPED WITH 4.5 TAP AND A RATCHETING T-HANDLE. WHEN APPROXIMATELY HALF WAY INTO THE PEDICLE WITH THE TAP, IT FRACTURED AND BROKE MIDWAY OF THE INSTRUMENTS FLUTED SECTION. A REMOVAL SET WAS USED TO SUCCESSFULLY RETRIEVE THE DETACHED SECTION AND DISCARDED BY THE USER FACILITY. THE SURGERY WAS COMPLETED BY RE-TAPPING THE TUNNEL USING A 5.5MM TAP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    446254 4.5MM TAP (STAINLESS STEEL) HWX HWX ALPHATEC SPINE INC 87007-045 7099602

    Patients

    Seq Age Sex Outcome Treatment
    1 Other