BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4.5MM JACOBS TAP (STAINLESS STEEL)

    MDR report key: 4903850 · Received July 9, 2015

    Report

    Report Number
    2027467-2015-00126
    Event Type
    Malfunction
    Date Received
    July 9, 2015
    Date of Event
    January 27, 2015
    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. VISUAL INSPECTION OF THE RETURNED INSTRUMENT FOUND IT HAD FRACTURED AND SEPARATED AT THE 60MM GRAPH MAKING LINE. 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

    TAP BROKE DURING PEDICLE PREPARATION USING A JACOBS ADAPTER DRILL WITH SETTINGS ON REAM. BROKEN PIECE WAS STUCK IN THE PATIENTS PEDICLE, IT TOOK ABOUT 15 MINUTES TO PULL OUT. PATIENT WAS INVOLVED, BUT NOT HURT. ALL BROKEN PIECES WERE REMOVED FROM THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    446218 4.5MM JACOBS TAP (STAINLESS STEEL) HWX HWX ALPHATEC SPINE INC 87049-045 7099612

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other