BEUDAMED
    FDA Adverse Event Other Summary report: N

    SUREFIRE SCORPION NEEDLE

    MDR report key: 1340337 · Received March 10, 2009

    Report

    Report Number
    1220246-2009-00021
    Event Type
    Other
    Date Received
    March 10, 2009
    Date of Event
    February 6, 2009
    Report Date
    February 10, 2009
    Manufacturer
    ARTHREX, INC.
    Product Code
    MDM
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED FOR EVALUATION. 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 INFORMATION AVAILABLE AND FROM DEVICE EVALUATION. 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 HAS BEEN 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 PATENT INJURY. TO AVOID THIS, REPOSITION THE NEEDLE PASS TO A DIFFERENT AREA. THIS IS THE SECOND COMPLAINT OF THIS TYPE FOR THIS PART/LOT COMBINATION. 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, THE TIP OF THE NEEDLE BROKE OFF INSIDE THE PATIENT'S CUFF. THE SURGEON ATTEMPTED TO RETRIEVE THE TIP BUT WAS NOT SUCCESSFUL. IT WAS REPORTED THAT THERE WERE NO PATIENT INJURIES. NO X-RAYS WERE TAKEN. 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 183357

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other INFORMATION REQUESTED BUT NOT PROVIDED.