BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MULTIFIRE SCORPION NEEDLE

    MDR report key: 3113006 · Received May 15, 2013

    Report

    Report Number
    1220246-2013-00079
    Event Type
    Injury
    Date Received
    May 15, 2013
    Date of Event
    December 27, 2012
    Report Date
    April 18, 2013
    Manufacturer
    ARTHREX, INC.
    Product Code
    MDM
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 REQUESTED FOR EVALUATION BUT WAS NOT RETURNED, THEREFORE, THE COMPLAINANT'S EVENT COULD NOT BE VERIFIED. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED FROM THE INFORMATION AVAILABLE AND WITHOUT DEVICE EVALUATION. LOT NUMBER WAS NOT PROVIDED SO DEVICE HISTORY RECORD REVIEW CANNOT BE PERFORMED. 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 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. UNKNOWN DEVICE DISPOSITION.

    Description of Event or Problem · 1

    IT WAS REPORTED IN A MEDWATCH REPORT THAT THE TIP OF SCORPION NEEDLE USED AS A SUTURE PASSER FOR THE ARTHROSCOPIC PORTION OF THE ROTATOR CUFF REPAIR, BROKE OFF. APPROXIMATELY 2/3 OF A MM. IN DIAMETER WAS IDENTIFIED BY X-RAY AND AN IMAGE IDENTIFIER. THIS BROKEN PIECE WAS UNABLE TO BE REMOVED. IT WAS FELT THAT FURTHER TISSUE PROBING WOULD BE DAMAGING TO THE SOFT TISSUES AND PROLONG ANESTHETIC IN PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    214724 MULTIFIRE SCORPION NEEDLE INSTRUMENT, MANUAL, SURGICAL, GENERAL USE MDM ARTHREX, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other