BEUDAMED
    FDA Adverse Event Other Summary report: N

    SUREFIRE SCORPION NEEDLE

    MDR report key: 1212765 · Received October 24, 2008

    Report

    Report Number
    1220246-2008-00210
    Event Type
    Other
    Date Received
    October 24, 2008
    Date of Event
    September 29, 2008
    Report Date
    October 3, 2008
    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

    A PORTION OF THE DEVICE WAS RECEIVED FOR EVAL. THE COMPLAINT WAS CONFIRMED. VISUAL INSPECTION OF THE RETURNED DEVICE REVEALED A BUCKLED NEEDLE WITH A BROKEN NEEDLE POINT. FUNCTION TESTING COULD NOT BE PERFORMED BECAUSE THE DEVICE WAS DAMAGED. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED FROM THE INFO AVAILABLE. DEVICE HISTORY RECORD REVIEW 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, OR HITTING BONE WITH THE NEEDLE. A NEW LABELING STATEMENT IS BEING RELEASED INSTRUCTING THE USER AS FOLLOWS: WARNING: DO NOT RESTERILIZED 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TIP OF THE NEEDLE BROKE OFF IN THE PATIENT. THE PROCEDURE WAS A ROTATOR CUFF REPAIR, SLAP REPAIR, DECOMPRESSION. AN X-RAY WAS PERFORMED, BUT TIP COULD NOT BE LOCATED. FOLLOW-UP WITH THE REPORTER PROVIDED INFO THAT ANOTHER NEEDLE WAS OPENED TO COMPLETE THE CASE. THE SURGERY WAS REPORTED AS HAVING A GOOD OUTCOME; THE SURGEON WAS ABLE TO FIX A LARGE TEAR ARTHROSCOPICALLY. THE PATIENT QUALITY OF BONE WAS REPORTED AS AVERAGE. NO FURTHER PATIENT INFO WAS PROVIDED AT THE TIME OF THIS REPORT OR MADE AVAILABLE IN RESPONSE TO FOLLOW-UP COMMUNICATION. NO ADD'L 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 60 YR Other REPORTED AS NONE.