BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SM BONE FASTAK, TAPERED NEEDLE W/#2-0 FIBERWIRE

    MDR report key: 2001445 · Received February 25, 2011

    Report

    Report Number
    1220246-2011-00023
    Event Type
    Injury
    Date Received
    February 25, 2011
    Date of Event
    January 28, 2011
    Report Date
    January 28, 2011
    Manufacturer
    ARTHREX, INC.
    Product Code
    HWC
    PMA / PMN Number
    K061863
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    RISK MANAGER

    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. THE MOST LIKELY CAUSE FOR THE SMALL NEEDLE FRAGMENT WOULD BE THE USE OF EXCESSIVE FORCE TO PASS THE NEEDLE THROUGH THICK OR HARD TISSUE OR HITTING BONE WITH THE NEEDLE. THE LOOSE SUTURE ANCHOR WAS MOST LIKELY DAMAGED AT THE TIME OF INSERTION WHICH LED TO THE BREAKAGE AND POST-OP FRAGMENT IN THE JOINT SPACE OR FROM POSSIBLE PATIENT POST-OP NON-COMPLIANCE. THIS IS THE FIRST COMPLAINT OF THIS TYPE FOR THIS PART/LOT NUMBER COMBINATION. THE POTENTIAL CAUSES OF THIS EVENT ARE BEING COMMUNICATED TO THE EVENT REPORTER. IF THE DEVICE IS RETURNED AND ADDITIONAL INFORMATION IS OBTAINED, A FOLLOW-UP REPORT WILL BE SUBMITTED. UNKNOWN DEVICE DISPOSITION.

    Description of Event or Problem · 1

    LEFT ELBOW EPICONDYLITIS (B)(6) 2010. FOUR MONTHS POST-OP, PATIENT WAS HAVING PAIN (LATERAL ELBOW PAIN). X-RAYS SHOWED A SMALL NEEDLE FRAGMENT; 2ND SURGERY WAS DONE (B)(6) 2010 TO REMOVE THE FRAGMENT AND LOOSE SUTURE ANCHOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SM BONE FASTAK, TAPERED NEEDLE W/#2-0 FIBERWIRE SCREW, FIXATION, BONE HWC ARTHREX, INC. 81276/90685

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Other