BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUREFIRE SCORPION NEEDLE

    MDR report key: 2831028 · Received November 14, 2012

    Report

    Report Number
    1220246-2012-00225
    Event Type
    Injury
    Date Received
    November 14, 2012
    Date of Event
    October 25, 2012
    Report Date
    October 25, 2012
    Manufacturer
    ARTHREX, INC.
    Product Code
    MDM
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT DEMOGRAPHICS (AGE AT TIME OF EVENT, DATE OF BIRTH, GENDER, WEIGHT) WERE REQUESTED BUT NOT PROVIDED. 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. THE DEVICE WAS RECEIVED AND AN EVALUATION WAS CONDUCTED. THE COMPLAINT WAS CONFIRMED. RETURNED DEVICE HAS A BROKEN NEEDLE POINT. DEVICE HISTORY RECORD REVIEW REVEALED NOTHING RELEVANT TO THIS EVENT. BASED ON THE INFORMATION PROVIDED AND DEVICE EVALUATION, THE MOST LIKELY CAUSE FOR 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. THERE IS A LABEL ON THE DEVICE WARNING THE USER AGAINST RE-STERILIZING, REUSING, HITTING BONE OR USE OF EXCESSIVE FORCE AS THESE MAY RESULT IN NEEDLE BREAKAGE OR PATIENT INJURY THIS IS THE FIRST COMPLAINT OF THIS TYPE FOR THIS PART/LOT COMBINATION. THE POTENTIAL CAUSE(S) OF THIS EVENT WILL BE COMMUNICATED TO THE EVENT REPORTER. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TIP OF THE SCORPION NEEDLE BROKE OFF DURING THE FIRST ATTEMPTED SUTURE PASS IN AN ARTHROSCOPIC CUFF REPAIR. THE TIP OF THE NEEDLE REMAINS UNRETRIEVED IN THE PATIENT'S TENDON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUREFIRE SCORPION NEEDLE INSTRUMENT, MANUAL, SURGICAL, GENERAL USE MDM ARTHREX, INC. 959619Q

    Patients

    Seq Age Sex Outcome Treatment
    1 Other