BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELITE STRAIGHT ATTACHMENT

    MDR report key: 13440446 · Received February 3, 2022

    Report

    Report Number
    13440446
    Event Type
    Malfunction
    Date Received
    February 3, 2022
    Date of Event
    January 27, 2022
    Report Date
    February 1, 2022
    Manufacturer
    STRYKER CORPORATION
    Product Code
    HBE
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    WHILE SURGEON WAS USING PI DRILL, DRILL FELL APART. NO PATIENT INJURY OCCURRED. START TIME: 0800. PRE-PROCEDURE DIAGNOSIS: LUMBAR DISC DISEASE. POST-PROCEDURE DIAGNOSIS: SAME AS PRE-PROCEDURE DX (DIAGNOSIS). PROCEDURES PERFORMED: ANTERIOR LUMBAR INTERBODY FUSION (L3/L4, L4/L5, L5/S1); 3-LEVEL. ALL NEEDLE COUNTS WERE CORRECT. MULTIPLE LATERAL PLAIN FILMS WERE OBTAINED AND SHOWED NO RETAINED INSTRUMENTS. THE PATIENT TOLERATED THE PROCEDURE WELL AND HE WAS TRANSPORTED TO RECOVERY ROOM IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1175177 ELITE STRAIGHT ATTACHMENT DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED) HBE STRYKER CORPORATION 5407-120-470

    Patients

    Seq Age Sex Outcome Treatment
    1 25550 DA Female