BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BICEPS TENODESIS REP

    MDR report key: 1697744 · Received May 13, 2010

    Report

    Report Number
    1219602-2010-00140
    Event Type
    Malfunction
    Date Received
    May 13, 2010
    Date of Event
    April 19, 2010
    Report Date
    April 19, 2010
    Manufacturer
    MANSFIELD
    Product Code
    HWC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS NOT RETURNED FOR EVALUATION. (B) (4)

    Description of Event or Problem · 1

    SURGEON PERFORMED A SUBPECTORAL PROCEDURE AND WORKED ON CORTICAL BONE. THE BONE HOLE PREP SITE WAS PREPARED WITH SAME SIZE DRILL AS ASSURED TENDON. THE SURGEON USED A 9MM TAP FOR THIS 9X15 BICEPTOR SCREW BECAUSE NO LARGER SIZE WAS AVAILABLE. TENDON WAS TWISTING AND SHREDDING IN THE FINAL STAGE OF CASE. THE SCREW BECAME LODGED ONTO THE DRIVER. THE DR HAD TO REMOVE THE SCREW AND USE ETHIBOND SUTURE INSTEAD TO COMPLETE CASE. IT WAS CONFIRMED THE TENDON WAS A LOOSE 8 MM TO A TIGHT 9 MM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BICEPS TENODESIS REP KIT, BICEPTOR DISPOSABLES, 9MM X 15MM / HWC HWC MANSFIELD 72202301 50294938

    Patients

    Seq Age Sex Outcome Treatment
    1