BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUREFIRE SCORPION NEEDLE

    MDR report key: 2013195 · Received March 10, 2011

    Report

    Report Number
    1220246-2011-00037
    Event Type
    Injury
    Date Received
    March 10, 2011
    Date of Event
    February 11, 2011
    Report Date
    February 14, 2011
    Manufacturer
    ARTHREX, INC.
    Product Code
    HRX
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    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. COMPLAINT CONFIRMED, EVENT CAUSED BY A BROKEN NEEDLE POINT. 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. DEVICE HISTORY RECORD REVEALED NOTHING RELEVANT TO THIS EVENT. THIS IS THE FIRST COMPLAINT OF THIS TYPE FOR THIS PART/LOT COMBINATION. THE POTENTIAL CAUSES OF THIS EVENT ARE BEING 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 DURING A ROTATOR CUFF REPAIR, THE TIP BROKE OFF IN THE CUFF. THE TIP REMAINS IN THE PATIENT. THE NEEDLE WAS LOADED CORRECTLY. THERE WAS SOME CALCIFIED BONE IN THE CUFF WHICH MADE THE ENTRY MORE DIFFICULT. THE DOCTOR USED A REGULAR SCORPION TO COMPLETE THE CASE. THERE WAS A 40 MINUTE TIME DELAY DUE TO THE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUREFIRE SCORPION NEEDLE INSTRUMENT, MANUAL, SURGICAL, GENERAL USE HRX ARTHREX, INC. 285728

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other AR-13992, SCORPION SUTURE PASSER, 20MM| AR-13993, SCORPION SUTURE PASSER, HUMPBACK| AR-13990, SCORPION SUTURE PASSER, 16MM