BEUDAMED
    FDA Adverse Event Other Summary report: N

    SUREFIRE SCORPION NEEDLE

    MDR report key: 1123766 · Received August 18, 2008

    Report

    Report Number
    1220246-2008-00155
    Event Type
    Other
    Date Received
    August 18, 2008
    Date of Event
    July 22, 2008
    Report Date
    July 22, 2008
    Manufacturer
    ARTHREX, INC.
    Product Code
    MDM
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED BECAUSE IT WAS DISCARDED BY THE HOSPITAL, THEREFORE, THE COMPLAINT'S EVENT COULD NOT BE VERIFIED. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED FROM THE INFO AVAILABLE. THE DEVICE HISTORY RECORD REVEALED NOTHING RELEVANT TO THIS EVENT. THE MOST LIKELY CAUSES OF THIS TYPE OF EVENT WOULD BE THE USE OF EXCESSIVE FORCE TO PASS THE NEEDLE THROUGH THICK OR HARD TISSUE AND HITTING BONE WITH THE NEEDLE. IF ADDITIONAL PT INFO IS OBTAINED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, DURING A ROTATOR CUFF REPAIR, THE NEEDLE INSERTION DEVICE WAS USED MULTIPLE TIMES IN AN ATTEMPT TO PASS THE NEEDLE THROUGH THE TISSUE. THE TIP OF THE NEEDLE BROKE OFF WHILE PASSING THE THIRD SUTURE. A SECOND NEEDLE WAS USED AND THE TIP ALSO BROKE. THIS NEEDLE TIP WAS NOT RETRIEVED FROM THE PT. THE SURGEON USED A BACK-UP DEVICE TO COMPLETE THE PROCEDURE. NO FURTHER PT INFO WAS PROVIDED AT THE TIME OF THIS REPORT OR MADE AVAILABLE IN RESPONSE TO FOLLOW-UP REQUESTS TO THE SURGICAL FACILITY. NO ADDITIONAL ADVERSE CONSEQUENCES HAVE BEEN REPORTED FROM THIS EVENT. THIS DEVICE IS USED FOR TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUREFIRE SCORPION NEEDLE MDM ARTHREX, INC. NA 170419

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Other