BEUDAMED
    FDA Adverse Event Other Summary report: N

    SUREFIRE SCORPION NEEDLE

    MDR report key: 1316675 · Received February 18, 2009

    Report

    Report Number
    1220246-2009-00015
    Event Type
    Other
    Date Received
    February 18, 2009
    Date of Event
    January 20, 2009
    Report Date
    January 30, 2009
    Manufacturer
    ARTHREX, INC.
    Product Code
    MDM
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS REQUESTED FOR EVALUATION BUT WAS NOT RETURNED, THEREFORE, THE COMPLAINANT'S EVENT COULD NOT BE VERIFIED. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED FROM THE INFORMATION AVAILABLE AND WITHOUT DEVICE EVALUATION. DEVICE HISTORY RECORD REVIEW REVEALED NOTHING RELEVANT TO THIS EVENT. BASED ON THE INFORMATION PROVIDED, 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 PATIENT INJURY. USE OF EXCESSIVE FORCE TO PASS THE NEEDLE THROUGH FIBROUS/CALCIFIC TISSUE, OR STRIKING BONE, CAN CAUSE NEEDLE BREAKAGE AND PATIENT 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. IF THE DEVICE IS RETURNED AND ADDITIONAL RELEVANT INFORMATION IS OBTAINED, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A RIGHT SHOULDER ARTHROSCOPY SURGERY, THE TIP OF THE NEEDLE BROKE OFF IN THE PATIENT'S SHOULDER. FLUOROSCAN WAS UTILIZED TO LOCATE THE TIP WITH NO SUCCESS; THE TIP OF THE NEEDLE WAS NOT RETRIEVED. THE SURGEON NOTED THE TIP OF THE NEEDLE WAS EXACTLY ADJACENT TO THE CORKSCREW ANCHOR DEEP TO THE CUFF AT THE GREATER TUBEROSITY. THE SURGEON FELT THAT THE TIP WOULD NOT COMPROMISE THE RESULT AND WOULD NOT CHANGE REHAB. NO FURTHER PATIENT INFORMATION WAS PROVIDED AT THE TIME OF THIS REPORT OR MADE AVAILABLE IN RESPONSE TO 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 178935

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Other INFORMATION REQUESTED BUT NO PROVIDED.