BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BICEPS TENODESIS INS

    MDR report key: 2340468 · Received November 17, 2011

    Report

    Report Number
    1219602-2011-00207
    Event Type
    Malfunction
    Date Received
    November 17, 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

    SMITH & NEPHEW, INC. ENDOSCOPY DIV.; IS SUBMITTING THE ENCLOSED REPORT TO COMPLY WITH 21 CFR 803, THE MDR REGULATION. THE REPORT IS BASED UPON INFORMATION OBTAINED BY SMITH & NEPHEW INC. ENDOSCOPY DIV. WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE DATE OF THE REPORT WAS REQUIRED BY FDA. 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 EXIT THE DRIVER THE SCREW CAME OUT WITH IT. TRIED SEVERAL TIMES AND SCREW KEPT STICKING TO THE DRIVER. INJURIES OR COMPLICATIONS- YES- EXTRA DRILL HOLE. SCREW USED PART NUMBER 72202284 LOT 50282687. 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, 72202285; LOT 50282688 THAT THEY COULD NOT REMOVE FROM THE DRIVER. SURGEON USED STARTER AND 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 INS BICEPTOR DRIVER MBI SMITH & NEPHEW ENDOSCOPY 72202190 50285895

    Patients

    Seq Age Sex Outcome Treatment
    1