BEUDAMED
    FDA Adverse Event Other Summary report: N

    SUREFIRE SCORPION NEEDLE

    MDR report key: 1081171 · Received July 1, 2008

    Report

    Report Number
    1220246-2008-00126
    Event Type
    Other
    Date Received
    July 1, 2008
    Date of Event
    May 23, 2008
    Report Date
    June 9, 2008
    Manufacturer
    ARTHREX, INC.
    Product Code
    HWQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY RECORD REVEALED NOTHING RELEVANT TO THIS EVENT. THIS IS THE FIRST COMPLAINT OF THIS TYPE FOR THIS PART/LOT COMBINATION. A DEFINITIVE CONCLUSION COULD NOT BE DETERMINED FROM THE INFO AVAILABLE. THE USER FACILITY HAS BEEN CONTACTED IN REGARDS TO THE DEVICE AVAILABILITY FOR EVAL BASED ON THE INFO PROVIDED IN THEIR MEDWATCH REPORT TO THE FDA. IF THE DEVICE IS RECEIVED AND RELEVANT INFO REGARDING THE CAUSE OF THE EVENT IS OBTAINED FROM THE EVAL, A FOLLOW UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TIP OF TWO SCORPION NEEDLES BROKE OFF DURING AN ARTHROSCOPIC ROTATOR CUFF REPAIR (RIGHT SHOULDER). IN EACH NEEDLE PASSING ATTEMPT, THE NEEDLES DID NOT DEPLOY CORRECTLY AND IN BOTH CASES, THE SURGEON NOTED THE TIPS WERE MISSING IN THE SURGICAL WOUND. X-RAY FILMS REVEALED BOTH TIPS ARE LOCATED IN THE SOFT TISSUE OF THE ROTATOR CUFF. A DECISION WAS MADE TO LEAVE BOTH TIPS IN PLACE VERSUS MORE INVASIVE SURGERY TO REMOVE THEM. NO FURTHER PT INFO IS AVAILABLE AT THIS TIME AND NO ADD'L 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 NEEDLE HWQ ARTHREX, INC. NA 170415

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Other