BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUREFIRE SCORPION NEEDLE

    MDR report key: 3982576 · Received August 6, 2014

    Report

    Report Number
    1220246-2014-00135
    Event Type
    Injury
    Date Received
    August 6, 2014
    Date of Event
    July 16, 2014
    Report Date
    July 16, 2014
    Manufacturer
    ARTHREX, INC.
    Product Code
    MDM
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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. THE COMPLAINT WAS CONFIRMED. DEVICE HISTORY RECORD REVIEW REVEALED NOTHING RELEVANT TO THIS EVENT. COMPLAINANT'S EVENT CAUSED BY A BROKEN NEEDLE POINT. THE MATING PART (INSTRUMENT) USED IN THE EVENT WAS NOT RETURNED. THE TYPICAL 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 NEEDLE BROKE UPON PASSING SUTURE THROUGH THE TENDON. THE SURGEON COMPLETED THE CASE WITH A SUTURE LASSO. NOTICED THE TIP REMAINED IN THE PATIENT AFTER VIEWING THE X-RAY. THE TIP OF THE NEEDLE WAS NOT RETRIEVED FROM THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    461796 SUREFIRE SCORPION NEEDLE INSTRUMENT, MANUAL, SURGICAL, GENERAL USE MDM ARTHREX, INC. 265700Z

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other