BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUREFIRE SCORPION NEEDLE HD

    MDR report key: 3161322 · Received June 11, 2013

    Report

    Report Number
    1220246-2013-00099
    Event Type
    Injury
    Date Received
    June 11, 2013
    Date of Event
    May 17, 2013
    Report Date
    May 17, 2013
    Manufacturer
    ARTHREX, INC.
    Product Code
    MDM
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, 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/IS EXPECTED FOR EVALUATION BUT HAS NOT YET BEEN RECEIVED. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED FROM THE INFORMATION AVAILABLE AND WITHOUT DEVICE EVALUATION. DEVICE HISTORY RECORD REVIEW REVEALED NOTHING RELEVANT TO THIS EVENT. BASED ON THE INFORMATION PROVIDED, 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 AS IS STATED IN THE EVENT DESCRIPTION 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 THE DEVICE IS RETURNED AND ADDITIONAL INFORMATION IS OBTAINED, A FOLLOW-UP REPORT WILL BE SUBMITTED. DEVICE EXPECTED BUT NOT YET RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR, THE NEEDLE TIP BROKE OFF IN THE PATIENT`S SOFT TISSUE. THE SURGEON WAS USING A HUMPBACK SCORPION AND WAS ABOUT THE 9TH PASS TRYING TO GET THROUGH SOME THICK TISSUE. AN X-RAY WAS TAKEN TO CONFIRM. THE TIP WAS NOT RETRIEVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    262967 SUREFIRE SCORPION NEEDLE HD INSTRUMENT, MANUAL, SURGICAL, GENERAL USE MDM ARTHREX, INC. 810573

    Patients

    Seq Age Sex Outcome Treatment
    1 Other