BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BICEPS TENODESIS REP

    MDR report key: 2342339 · Received November 18, 2011

    Report

    Report Number
    1219602-2011-00208
    Event Type
    Malfunction
    Date Received
    November 18, 2011
    Date of Event
    October 20, 2011
    Report Date
    October 21, 2011
    Manufacturer
    SMITH & NEPHEW ENDOSCOPY
    Product Code
    MBI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS NOT BEING RETURNED FOR EVALUATION. (B)(4).

    Description of Event or Problem · 1

    DURING SURGERY THE DR. TRIED TO IMPLANT THE SCREW AND WHEN HE TRIED TO EXIT THE DRIVER THE SCREW CAME WITH IT. TRIED SEVERAL TIMES AND SCREW KEPT STICKING TO THE DRIVER. INJURIES OR COMPLICATIONS- YES - EXTRA DRILL HOLE. ON (B)(6) 2011 FOLLOW UP WITH CUSTOMER IN REGARDS TO STATUS OF DEVICE AS WELL AS CLARIFICATION ON INCIDENT. CUSTOMER INDICATED THAT THERE WAS ALSO A 9MM SCREW USED AS WELL, (B)(4); LOT 50282688 THAT THEY COULD NOT REMOVE FROM THE DRIVER. SHE STATED THE FOLLOWING: SURGEON USED STARTER & TAP; INSERTED SCREWS AND WENT TO REMOVE DRIVER AND THE SCREWS WERE STUCK ON THE DRIVER. THE 2 HOLES WERE LEFT EMPTY; SURGEON COMPLETED PROCEDURE USING UNKNOWN SUTURING TECHNIQUE. DEVICES WERE DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BICEPS TENODESIS REP BICEPTOR BIOSURE PK SCREW 8MM X 15MM MBI SMITH & NEPHEW ENDOSCOPY 72202284 50282687

    Patients

    Seq Age Sex Outcome Treatment
    1