BEUDAMED
    FDA Adverse Event Other Summary report: N

    SPEEDSCREW 5.5 IMPLANT WITH INSERTER HANDLE

    MDR report key: 2111107 · Received May 24, 2011

    Report

    Report Number
    2032380-2011-00051
    Event Type
    Other
    Date Received
    May 24, 2011
    Date of Event
    January 1, 2011
    Report Date
    May 24, 2011
    Manufacturer
    ARTHROCARE CORP.
    Product Code
    HWC
    PMA / PMN Number
    K081893
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DATE OF THE EVENT WAS REQUESTED, BUT TO DATE, HAS NOT BEEN PROVIDED, THEREFORE, AN APPROXIMATE YEAR WAS USED. THE DEVICE WAS RETURNED FOR INVESTIGATION. THE INVESTIGATION IS IN PROGRESS. A F/U REPORT WILL BE PROVIDED ONCE THE DEVICE INVESTIGATION AND LOT HISTORY REVIEW ARE COMPLETED. THE TWO ADD'L DEVICES USED IN THE SAME PROCEDURE WERE FILED UNDER MDR 2032380-2011-00050 AND 2032380-2011-00052. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED TO ARTHROCARE ON (B)(6) 2011 THAT A PT UNDERWENT AN ARTHROSCOPIC REFIXATION AUTO CUFF PROCEDURE, USING THREE OPUS SPEEDSCREW 5.5 IMPLANTS. ALLEGEDLY, ON ALL THREE OF THE IMPLANTS, THE WIRE DID NOT PROPERLY CONVEY AND BROKE. THE SURGEON REVERTED TO A MINI-OPEN PROCEDURE TO COMPLETE THE REPAIR, RESULTING IN A SURGICAL DELAY OF APPROX 90 MINUTES. THE SURGERY WAS COMPLETED WITHOUT FURTHER INCIDENT AND WITHOUT PT INJURY. IT WAS REPORTED THAT ANTIBIOTICS WERE ADMINISTERED AS PART OF THE PT'S TREATMENT DUE TO REVERTING TO A MINI-OPEN PROCEDURE AND DUE TO THE DELAY, WHICH WAS NOT PART OF THE ORIGINAL PLANNED TREATMENT.

    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. 1011645

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Other