BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BICEPS TENODESIS REP

    MDR report key: 1815113 · Received August 25, 2010

    Report

    Report Number
    1219602-2010-00219
    Event Type
    Malfunction
    Date Received
    August 25, 2010
    Date of Event
    July 16, 2010
    Report Date
    August 6, 2010
    Manufacturer
    SMITH & NEPHEW ENDOSCOPY
    Product Code
    HRX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE PROCEDURE WAS DONE ARTHROSCOPICALLY. THE TENDON WAS DETACHED AND THE DRILL HOLE PREPARED AS PER RECOMMENDED TECHNIQUE. SURGEON INSERTED THE SCREW IN THE DRILL HOLE TO REATTACH THE TENDON, THE TENDON CAME OUT OF THE HOLE. THE SCREW WAS THEN TOO BIG FOR THE HOLE SO HAD TO BE TAKEN OUT. THE SCREW THEN CAME OFF AND THE SURGEON WAS UNABLE TO FIND IT. THE SURGEON RESORTED TO A MINI-OPEN PROCEDURE TO FIND THE SCREW, BUT HE COULDN'T FIND THE SCREW. AS THE MATERIAL WAS PEEK, THE SURGEON COULDN'T USE X-RAY TO LOCATE THE SCREW. THE SCREW WAS LEFT IN THE PATIENT AS THE SURGEON WAS UNABLE TO FIND IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BICEPS TENODESIS REP KIT, BICEPTOR DISPOSABLES , 8X25MM HRX SMITH & NEPHEW ENDOSCOPY 72202358 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1