BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DYNANITE NITI STAPLE W/INSTRS 18WX18L

    MDR report key: 7923115 · Received October 1, 2018

    Report

    Report Number
    1220246-2018-00684
    Event Type
    Injury
    Date Received
    October 1, 2018
    Date of Event
    March 16, 2018
    Report Date
    December 18, 2018
    Manufacturer
    ARTHREX, INC.
    Product Code
    JDR
    UDI-DI
    00888867288140
    PMA / PMN Number
    K172052
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CONTRIBUTION OF THE DEVICE TO THE REPORTED EVENT COULD NOT BE DETERMINED AS THE DEVICE WAS REQUESTED/IS EXPECTED BUT HAS NOT RETURNED FOR EVALUATION. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED FROM THE INFORMATION AVAILABLE AND WITHOUT DEVICE EVALUATION.

    Additional Manufacturer Narrative · 1

    COMPLAINT CONFIRMED. DIMENSIONAL AND MATERIAL ANALYSIS RESULTS CONFIRMED THE AR-8719DS-1818 MET ALL AS-RECEIVED CONDITIONS. VISUAL EVALUATION REVEALED THAT APPROXIMATELY 10.92MM OF ONE OF THE STAPLE LEGS HAD BROKEN OFF OF THE DEVICE PRIOR TO RECEIPT FOR INVESTIGATION. THIS EVENT IS MOST LIKELY CAUSED BY USER MECHANICAL DAMAGE TO DEVICE, SUCH AS HITTING THE DEVICE WITH ANOTHER DEVICE, PRYING/LEVERAGING, OR EXCESSIVE BENDING FORCES APPLIED DURING USE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEG ON THE AR-8719DS-1818, DYNANITE NITINOL STAPLE IMPLANT SYSTEM 18W X 18L IS BROKEN. THE REP STATED THAT IT IS UNKNOWN HOW OR WHEN THE IMPLANT LEG BROKE. THE PATIENT CAME BACK FOR A FOLLOW UP VISIT AND THE DEVICE WAS DISCOVERED BROKEN ON THE X-RAY THAT WAS TAKEN. THE REP STATED THAT THE AR-8719DS-1818 REMAINS IMPLANTED IN THE PATIENT, AND THAT THERE IS NOT ANY RECORD OF PATIENT DISCOMFORT. THE REP REPORTED THAT THE SURGEON IS DISCUSSING A HARDWARE REMOVAL SURGERY. ADDITIONAL INFORMATION REQUESTED REGARDING DATE OF REMOVAL. ADDITIONAL INFORMATION RECEIVED ON 09/12/2018: THE REP CONFIRMED THAT THE ORIGINAL PROCEDURE TOOK PLACE ON (B)(6) 2018. THE REVISION SURGERY HAS BEEN SCHEDULED FOR (B)(6) /2018. ADDITIONAL INFORMATION RECEIVED ON 09/14/2018: THE REP CONFIRMED THAT A HARDWARE REMOVAL AND REVISION EVANS PROCEDURE WITH ILLIAC CREST PLATE FIXATION TOOK PLACE ON (B)(6) 2018. THE REVISION WAS COMPLETED BY THE SAME SURGEON WHO PERFORMED THE ORIGINAL SURGERY, AND TOOK AT THE SAME FACILITY WHERE THE ORIGINAL SURGERY WAS PERFORMED. THE FOLLOWING ARTHREX PART AND LOT NUMBERS WERE EXPLANTED DURING THE REVISION SURGERY ON (B)(6) 2018: 1. AR-8719DS-1818 / LOT: 800980008. 2. AR-8942W-1810 / LOT: 4210. THE FOLLOWING ARTHREX PART AND LOT NUMBERS WERE IMPLANTED DURING THE REVISION SURGERY ON (B)(6) 2018: 1. AR-8942R-L / LOT: 10123947. 2. AR-8935-20 / LOT: 10001844. 3. AR-8935-22 / LOT: 10001427. 4. AR-8935L-20 / LOT: 1336554. 5. AR-8935L-22 / LOT: 191236. ADDITIONAL INFORMATION RECEIVED ON 09/20/2018: THERE WERE TWO ARTHREX REPRESENTATIVES PRESENT DURING THE REVISION SURGERY. THE BROKEN STAPLE WAS REMOVED WITH NO NEW IMPLANT USED IN THE SAME SITE. THE REP CONFIRMED THAT THE BONE QUALITY WAS GOOD. DURING THE REVISION SURGERY THE SURGEON PERFORMED ANOTHER PROCEDURE IN THE CALCANEUS USING AN H PLATE. AN ALLOSYNC 1 CC GRAFT WAS USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    763889 DYNANITE NITI STAPLE W/INSTRS 18WX18L STAPLE, FIXATION, BONE JDR ARTHREX, INC. DYNANITE NITI STAPLE W/INSTRS 18WX18L 800980008 00888867288140

    Patients

    Seq Age Sex Outcome Treatment
    1 Other