BEUDAMED
    FDA Adverse Event Other Summary report: N

    SUREFIRE SCORPION NEEDLE

    MDR report key: 1313216 · Received February 13, 2009

    Report

    Report Number
    1220246-2009-00008
    Event Type
    Other
    Date Received
    February 13, 2009
    Date of Event
    January 20, 2009
    Report Date
    January 22, 2009
    Manufacturer
    ARTHREX, INC.
    Product Code
    MDM
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED FOR EVAL. THE COMPLAINANT'S EVENT WAS CONFIRMED, THE TIP OF THE NEEDLE WAS BROKEN OFF/MISSING. FUNCTION TEST COULD NOT BE PERFORMED DUE TO DEVICE DAMAGE. THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED FROM THE INFO AVAILABLE AND FROM DEVICE EVAL. DEVICE HISTORY RECORD REVIEW REVEALED NOTHING RELEVANT TO THIS EVENT. THE MOST LIKELY CAUSE OF THIS TYPE OF EVENT WOULD BE THE USE OF EXCESSIVE FORCE TO PASS THE NEEDLE THROUGH THICK OR HARD TISSUE OR HITTING BONE WITH THE NEEDLE. A NEW LABELING STATEMENT IS BEING PLACED ON THE DEVICE PACKAGE, INSTRUCTING THE USER AS FOLLOWS: WARNING: DO NOT RESTERILIZE OR REUSE THE SCORPION NEEDLE. THIS MAY CAUSE THE NEEDLE TO BREAK AND CAUSE PT INJURY. USE OF EXCESSIVE FORCE TO PASS THE NEEDLE THROUGH FIBROUS/CALCIFIC TISSUE, OR STRIKING BONE, CAN CAUSE NEEDLE BREAKAGE AND PT INJURY. TO AVOID THIS, REPOSITION THE NEEDLE PASS TO A DIFFERENT AREA. THE POTENTIAL CAUSES OF THIS EVENT ARE BEING COMMUNICATED TO THE EVENT REPORTER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR CASE THE TIP OF THE NEEDLE BROKE OFF. SURGEON DID ATTEMPT TO RETRIEVE THE TIP BUT WAS UNSUCCESSFUL. THE SURGEON USED ANOTHER ONE TO COMPLETE THE CASE. NO FURTHER PT INFO WAS PROVIDED AT THE TIME OF THIS REPORT OR IN FOLLOW-UP COMMUNICATION. 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 170418

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Other INFO REQUESTED BUT NOT PROVIDED.