BEUDAMED
    FDA Adverse Event Other Summary report: N

    SPEEDSCREW 5.5 IMPLANT WITH INSERTER HANDLE

    MDR report key: 2001133 · Received February 18, 2011

    Report

    Report Number
    2032380-2011-00007
    Event Type
    Other
    Date Received
    February 18, 2011
    Date of Event
    January 19, 2011
    Report Date
    February 18, 2011
    Manufacturer
    ARTHROCARE CORP.
    Product Code
    HWC
    PMA / PMN Number
    K081893
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS CURRENTLY IN PROGRESS. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE. A SECOND DEVICE USED IN THE SAME PROCEDURE WAS FILED UNDER MDR 2032380-2011-00008. (B)(4).

    Description of Event or Problem · 1

    ON (B)(6), 2011, IT WAS REPORTED TO ARTHROCARE THAT A PATIENT UNDERWENT AN ARTHROSCOPIC ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2011, USING TWO OPUS SPEEDSCREW 5.5 IMPLANTS. THE WHITE AND GREEN SNARE LINES, WHICH ARE PRELOADED IN THE INSERTER HANDLE OF THE IMPLANT, BECAME LOOSE WHEN SCREWING THE IMPLANT INTO PLACE. TO COMPLETE THE REPAIR, THE SURGEON REVERTED TO A MINI-OPEN PROCEDURE. THE SURGERY WAS COMPLETED WITHOUT FURTHER INCIDENT AND WITHOUT PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPEEDSCREW 5.5 IMPLANT WITH INSERTER HANDLE FASTENER, FIXATION, NONDEGRADABLE, SOFT HWC ARTHROCARE CORP. 1012743

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Other