BEUDAMED
    FDA Adverse Event Other Summary report: N

    SPEEDSCREW 5.5 IMPLANT WITH INSERTER HANDLE

    MDR report key: 1993421 · Received February 10, 2011

    Report

    Report Number
    2032380-2011-00006
    Event Type
    Other
    Date Received
    February 10, 2011
    Date of Event
    December 20, 2010
    Report Date
    February 10, 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 PT'S AGE AND GENDER WERE REQUESTED BUT TO DATE HAVE NOT BEEN PROVIDED. IT WAS REPORTED THAT THE DEVICE WILL BE RETURNED FOR INVESTIGATION. TO DATE THE DEVICE HAS NOT BEEN RECEIVED. A FOLLOW-UP REPORT WILL BE PROVIDED ONCE THE DEVICE INVESTIGATION AND LOT HISTORY REVIEW ARE COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO ARTHROCARE THAT A PT UNDERWENT AN ARTHROSCOPIC ROTATOR CUFF REPAIR PROCEDURE USING AN OPUS SPEEDSCREW 5.5 IMPLANT. THE MAGNUMWIRE SUTURE GOT STUCK IN FRONT OF THE IMPLANT AND COULD NOT BE MOVED INTO THE IMPLANT, THEREFORE THE SUTURE COULD NOT BE THREADED CORRECTLY. TO COMPLETE THE REPAIR, THE SURGEON REVERTED TO A MINI-OPEN PROCEDURE. IT WAS REPORTED THAT THE IMPLANT WAS REMOVED SUCCESSFULLY, BUT RESULTED IN A SURGICAL DELAY OF APPROXIMATELY 30 MINS. THE SURGERY WAS COMPLETED WITHOUT FURTHER INCIDENT AND WITHOUT PT 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. 1010277

    Patients

    Seq Age Sex Outcome Treatment
    1 Other