BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PIN, BIO-TRANSFIX, 5MM

    MDR report key: 2213818 · Received August 17, 2011

    Report

    Report Number
    1220246-2011-00122
    Event Type
    Injury
    Date Received
    August 17, 2011
    Date of Event
    May 20, 2010
    Report Date
    July 18, 2011
    Manufacturer
    ARTHREX, INC.
    Product Code
    MAI
    PMA / PMN Number
    K062466
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    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. DEVICE HISTORY RECORD REVEALED NOTHING RELEVANT TO THIS EVENT. THE DEVICE WAS REQUESTED FOR EVALUATION BUT PART REMAINS IN THE PATIENT AND THE PART THAT WAS REMOVED WILL NOT BE 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. A LIKELY CAUSE OF THE EVENT IS PATIENT NON-COMPLIANCE POST-OP. PRODUCT DIRECTIONS FOR USE ((B)(4)) STATES POST-OPERATIVELY AND UNTIL BONE HEALING IS COMPLETE, FIXATION PROVIDED BY THIS DEVICE SHOULD BE CONSIDERED AS TEMPORARY AND MAY NOT WITHSTAND WEIGHT BEARING OR OTHER UNSUPPORTED STRESS. THE FIXATION PROVIDED BY THIS DEVICE SHOULD BE PROTECTED. THE POST-OPERATIVE REGIMEN PRESCRIBED BY THE PHYSICIAN SHOULD BE STRICTLY FOLLOWED TO AVOID ADVERSE STRESSES APPLIED TO THE DEVICE. THIS IS THE FIRST COMPLAINT OF THIS TYPE FOR THIS PART/LOT COMBINATION. THE POTENTIAL CAUSES OF THIS EVENT ARE BEING COMMUNICATED TO THE EVENT REPORTER. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TRANS-FIX HAD BROKEN POST-OPERATIVELY. PRIOR TO THIS REPORT, THE PATIENT SAID THAT HE HAD ONE PIECE REMOVED WHICH WAS RUBBING ON HIS ILIOTIBIAL (IT) BAND. HE HAD AN X-RAY DONE THAT SHOWED A 3MM PIECE IN THE SOFT TISSUE TOWARDS THE BACKSIDE OF HIS KNEE. PENDING HIS DECISION TO HAVE HIS KNEE OPENED AGAIN. DOS (B)(6) 2010.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PIN, BIO-TRANSFIX, 5MM FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE MAI ARTHREX, INC. 294902

    Patients

    Seq Age Sex Outcome Treatment
    1 Other