BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MULTIFIRE SCORPION NEEDLE

    MDR report key: 2103282 · Received May 26, 2011

    Report

    Report Number
    1220246-2011-00078
    Event Type
    Injury
    Date Received
    May 26, 2011
    Date of Event
    April 20, 2011
    Report Date
    April 26, 2011
    Manufacturer
    ARTHREX, INC.
    Product Code
    HRX
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NURSE

    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. LOT NUMBER WAS REQUESTED BUT NOT PROVIDED, THEREFORE DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED. COMPLAINANT'S 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. 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

    TWO NEEDLES BROKE DURING A ROTATOR CUFF REPAIR. FIRST ONE EASILY RETRIEVED. SURGEON HAD TO MAKE AN UNPLANNED INCISION TO RETRIEVE THE 2ND NEEDLE,EXTENDING CASE 90 MINUTES. COMPLETED WITH COMPETITORS DEVICE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Other