BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUREFIRE SCORPION NEEDLE

    MDR report key: 1932677 · Received December 20, 2010

    Report

    Report Number
    1220246-2010-00252
    Event Type
    Injury
    Date Received
    December 20, 2010
    Date of Event
    November 5, 2010
    Report Date
    December 10, 2010
    Manufacturer
    ARTHREX, INC.
    Product Code
    HRX
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    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 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. DEVICE HISTORY RECORD REVEALED NOTHING RELEVANT TO THIS EVENT.BASED ON THE INFORMATION PROVIDED, THE MOST LIKELY CAUSE OF THIS EVENT WOULD BE THE USE OF EXCESSIVE FORCE TO PASS THE NEEDLE THROUGH THE THICK OR HARD TISSUE ENCOUNTERED. ON THE PACKAGE, THERE IS A LABEL 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 OF 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. THIS IS THE FIRST COMPLAINT OF THIS TYPE FOR THIS PART/LOT COMBINATION. IF THE DEVICE IS RETURNED AND ADDITIONAL INFORMATION IS OBTAINED, A FOLLOW-UP REPORT WILL BE SUBMITTED. H3 OTHER TEXT : UNKNOWN DEVICE DISPOSITION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A HALF CENTIMETER TIP OF NEEDLE BROKE OFF IN PATIENT SHOULDER; NOT RETRIEVED. AREA WAS IRRIGATED. NO X-RAYS WERE TAKEN TO CONFIRM THE TIP WAS STILL IN THE SHOULDER. RIGHT SHOULDER SCOPE AND REPAIR.MEDWATCH REPORT- 2300530000-2010-8065NO FURTHER PATIENT OR EVENT INFORMATION WAS PROVIDED AT THE TIME THIS EVENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUREFIRE SCORPION NEEDLE INSTRUMENT, MANUAL, SURGICAL, GENERAL USE HRX ARTHREX, INC. 342682

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Other (B)(4) , SCORPION SUTURE PASSER, 20MM| (B)(4) , SCORPION SUTURE PASSER, 16MM| (B)(4) , SCORPION SUTURE PASSER, HUMPBACK