BEUDAMED
    FDA Adverse Event Other Summary report: N

    SPEEDSCREW 5.5 IMPLANT WITH INSERTER HANDLE

    MDR report key: 2101195 · Received May 19, 2011

    Report

    Report Number
    2032380-2011-00055
    Event Type
    Other
    Date Received
    May 19, 2011
    Date of Event
    April 19, 2011
    Report Date
    May 19, 2011
    Manufacturer
    ARTHROCARE CORP.
    Product Code
    HWC
    PMA / PMN Number
    K081893
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL INSPECTION OF THE DEVICE WAS PERFORMED. THE DEVICE WAS RECEIVED DEPLOYED. COBRAID MAGNUMWIRE WAS RECEIVED REELED THROUGH AND THE SUTURE ENDS WERE FOUND BROKEN/SHREDDED. BASED ON THE OBSERVATIONS, IT'S BELIEVED THAT THE SUTURE WAS OVER TENSIONED, WHICH CAUSED THE SUTURE TO BREAK. THE ANCHOR WAS NOT RETURNED THEREFORE IT CAN'T BE INSPECTED. A LOT HISTORY REVIEW WAS ALSO PERFORMED. NO ABNORMALITIES WERE FOUND THAT WERE RELATED TO THE PRODUCT PROBLEM. THE ROOT CAUSE OF THE PRODUCT PROBLEM WAS DETERMINED TO BE FROM EXCESSIVE TENSIONING (OVER TENSIONING THE SUTURE) OR FORCE. THE SECOND DEVICE USED IN THE PROCEDURE WAS FILED UNDER MDR 203280-2011-00054. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED TO ARTHROCARE THAT A PATIENT UNDERWENT AN ARTHROSCOPIC ROTATOR CUFF REPAIR PROCEDURE USING TWO OPUS SPEEDSCREW 5.5 IMPLANTS. ALLEGEDLY, ONE OF THE IMPLANTS DID NOT DEPLOY AND LOCK THE SUTURE. THE SURGEON LOST VISUALIZATION OF THE SECOND IMPLANT AND REVERTED TO A MINI-OPEN PROCEDURE TO COMPLETE THE REPAIR. 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. 1014870

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Other