BEUDAMED
    FDA Adverse Event Other Summary report: N

    SUREFIRE SCORPION NEEDLE

    MDR report key: 1182387 · Received September 30, 2008

    Report

    Report Number
    1220246-2008-00191
    Event Type
    Other
    Date Received
    September 30, 2008
    Date of Event
    August 1, 2008
    Report Date
    September 2, 2008
    Manufacturer
    ARTHREX, INC.
    Product Code
    MDM
    PMA / PMN Number
    EXCEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED FOR EVALUATION. THE DEVICE WAS CONFIRMED TO HAVE A BROKEN NEEDLE POINT. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED FROM THE DEVICE INVESTIGATION FUNCTION TESTING COULD NOT BE CONDUCTED DUE TO DEVICE DAMAGE. DEVICE HISTORY RECORD REVIEW REVEALED NOTHING RELEVANT TO THIS EVENT. BASED ON THE INFORMATION PROVIDED AND DEVICE EVALUATION, THE MOST LIKELY CAUSE OF THIS TYPE OF EVENT IS USE OF EXCESSIVE FORCE TO PASS THE NEEDLE THROUGH THICK OR HARD TISSUE OR HITTING BONE WITH THE NEEDLE. A NEW LABELING STATEMENT IS BEING RELEASED 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. THE POTENTIAL CAUSES OF THIS EVENT ARE BEING COMMUNICATED TO THE EVENT REPORTER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A NEEDLE TIP BROKE DURING A ROTATOR CUFF REPAIR CASE. THE EVENT OCCURRED WHILE PASSING SUREFIRE SCORPION NEEDLES WITH SUTURES THROUGH TENDON IN A SHOULDER. AFTER FOUR-FIVE PASSES (USES), 1MM OF THE NEEDLE TIP BROKE OFF IN THE PATIENT'S RIGHT SHOULDER. THE SURGEON WAS UNABLE TO VISUALIZE THE FRAGMENT. FOLLOW-UP WITH THE REPORTER PROVIDED INFORMATION THAT THE PROCEDURE BEING PERFORMED WITH A RIGHT SHOULDER ARTHROSCOPY, ROTATOR CUFF REPAIR, BICEPS TENODESIS, ACROMIOPLASTY, DEBRIDEMENT. THE TIP WAS NOT RETRIEVED FROM THE PATIENT. THE CASE WAS COMPLETED WITH NO PATIENT INJURY REPORTED. NO FURTHER PATIENT INFORMATION WAS PROVIDED AT THIS TIME OF THIS REPORT OR IN RESPONSE TO FOLLOW-UP COMMUNICATION. NO ADDITIONAL ADVERSE CONSEQUENCE HAVE BEEN REPORTED FROM THIS EVENT. THE DEVICE IS USED FOR TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUREFIRE SCORPION NEEDLE MDM ARTHREX, INC. NA 170418

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Other INFORMATION REQUESTED BUT NOT PROVIDED