BEUDAMED
    FDA Adverse Event Other Summary report: N

    SUREFIRE SCORPION NEEDLE

    MDR report key: 1316677 · Received February 18, 2009

    Report

    Report Number
    1220246-2009-00014
    Event Type
    Other
    Date Received
    February 18, 2009
    Date of Event
    January 22, 2009
    Report Date
    January 29, 2009
    Manufacturer
    ARTHREX, INC.
    Product Code
    MDM
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICES WERE REQUESTED FOR EVALUATION BUT WERE NOT RETURNED BECAUSE RISK MANAGEMENT WOULD NOT RELEASE THEM (THE REMAINING NEEDLES), 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. DEVICE HISTORY RECORD REVIEW REVEALED NOTHING RELEVANT TO THIS EVENT. THE ACTUAL DEVICE USED TO INSERT THE NEEDLES WAS REPORTED TO BE USED AGAIN THE NEXT DAY WITH NO ISSUES. BASED ON THE INFORMATION PROVIDED, THE MOST LIKELY CAUSE OF THIS EVENT WOULD BE THE USE OF EXCESSIVE FORCE TO PASS THE NEEDLES THROUGH THE PATIENT'S UNUSUALLY THICK TENDON. A NEW LABELING STATEMENT IS BEING PLACED ON THE DEVICE PACKAGE, INSTRUCTING THE USER AS FOLLOWS: "WARNING: DO NOT RESTERILIZE OR REUSE THE SCORPION NEEDLE. THIS MAY CAUSE THE NEEDLE TO BREAK AND CAUSE PATIENT INJURY. USE EXCESSIVE FORCE TO PASS THE NEEDLE THROUGH FIBROUS/CALCIFIC TISSUE, OR STRIKING BONE, CAN CAUSE NEEDLE BREAKAGE AND PATIENT INJURY. TO AVOID THIS, REPOSITION THE NEEDLE PASS TO A DIFFERENT AREA." THE POTENTIAL CAUSES OF THIS EVENT ARE BEING COMMUNICATED TO THE EVENT REPORTER. IF THE DEVICES ARE RETURNED AND ADDITIONAL RELEVANT INFORMATION IS OBTAINED, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR, TWO SCORPION NEEDLE TIPS BROKE OFF IN THE PATIENT'S SHOULDER. THE REPORTER STATED THAT THE PATIENT'S TENDON WAS UNUSUALLY THICK. IT WAS INITIALLY REPORTED THAT THE CASE TOOK 4-5 HOURS INSTEAD OF THE USUAL TWO HOURS; HOWEVER, FOLLOW-UP COMMUNICATION WAS PROVIDED THAT THERE WAS NO INDICATION IN THE OPERATIVE REPORT THAT THE DELAY WAS DUE TO THE NEEDLE TIPS BREAKING. AN X-RAY WAS TAKEN WHICH CONFIRMED THE NEEDLE TIPS WERE IN THE PATIENT'S SHOULDER; THE TWO TIPS WERE NOT RETRIEVED. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUREFIRE SCORPION NEEDLE MDM ARTHREX, INC. NA 170421

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Other NO RELEVANT DATA PROVIDED.