BEUDAMED
    FDA Adverse Event Other Summary report: N

    SUREFIRE SCORPION NEEDLE

    MDR report key: 1047908 · Received May 14, 2008

    Report

    Report Number
    1220246-2008-00082
    Event Type
    Other
    Date Received
    May 14, 2008
    Date of Event
    April 14, 2008
    Report Date
    April 15, 2008
    Manufacturer
    ARTHREX, INC.
    Product Code
    GAB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED AND REVIEW OF THE DEVICE HISTORY REVEALED NOTHING RELEVANT TO THIS EVENT. PRODUCT HISTORY REVEALED THAT BROKEN NEEDLES (NOT AT WELD) WILL TYPICALLY OCCUR IF; THE USER APPLIES EXCESSIVE FORCE WHILE TRYING TO PASS THE NEEDLE THROUGH TOO MUCH TISSUE AND/OR THE DEVICE TIP UNEXPECTEDLY STRIKES THE PT'S BONE. THE CAUSE OF THIS EVENT, HOWEVER, COULD NOT BE DETERMINED FROM THE INFO AVAILABLE AND WITHOUT DEVICE EVAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TIP OF THE NEEDLE BROKE OFF AT THE NOTCH DURING A ROTATOR CUFF REPAIR. THE NEEDLE TIP WAS FOUND BY X-RAY BUT COULD NOT BE RETRIEVED. NO FURTHER PT INFO WAS PROVIDED AND NO ADD'L ADVERSE CONSEQUENCES HAVE BEEN REPORTED FROM THE EVENT. THIS DEVICE IS USED FOR TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUREFIRE SCORPION NEEDLE NEEDLE GAB ARTHREX, INC. NA 170414

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other