BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOCK DISTAL FIBULA PLT,SS LFT,5H

    MDR report key: 7625162 · Received June 21, 2018

    Report

    Report Number
    1220246-2018-00514
    Event Type
    Injury
    Date Received
    June 21, 2018
    Date of Event
    May 31, 2018
    Report Date
    June 21, 2018
    Manufacturer
    ARTHREX, INC.
    Product Code
    HRS
    UDI-DI
    00888867052529
    PMA / PMN Number
    K141478
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, 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 NOT RETURNED FOR EVALUATION. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED FROM THE INFORMATION AVAILABLE AND WITHOUT DEVICE EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A REVISION LT ANKLE FX PROCEDURE A TOTAL OF QTY. 3 AR-8827L-12 (LOT: 031731, LOT: 10158067, LOT: 185363) AND QTY. 2 AR-8827L-14 (LOT: 031725) WOULD NOT STAY ENGAGED IN THE PLATE. THE BONE WAS PREPPED BY A 2.0 MM DRILL. ADDITIONAL INFORMATION RECEIVED 6/12/2018: THE ORIGINAL SURGERY TOOK PLACE ON (B)(6) 2017. THE TYPE OF PROCEDURE BEING PERFORMED WAS A FIBULA FX. THE CASE TOOK PLACE AT (B)(6) REGIONAL HOSPITAL AND THE SURGERY WAS PERFORMED BY DR. (B)(6). THE FOLLOWING ARTHREX PART NUMBERS WERE IMPLANTED DURING THE (B)(6) 2017 PROCEDURE (LOT NUMBERS OF THE DEVICES ARE UNKNOWN). AR-8943BL-05, AR-8835-12 (QTY. 2), AR-8830-14 (QTY. 1), AR-8835-14 (QTY. 1), AR-8827L-14 (QTY. 3), AR-8827L-10 (QTY. 1). THE REVISION SURGERY TOOK PLACE ON (B)(6) 2018 TO FIX A HIGH NON UNION FIBULA FX. IT IS UNKNOWN IF OR WHAT SPECIFIC PART AND LOT NUMBERS WERE EXPLANTED DURING THE (B)(6) 2018 REVISION SURGERY. DURING THE REVISION SURGERY, A 2.7 LOCKING GUIDE WAS PLACED INTO THE LOCKING HOLE. THE BONE WAS DRILLED WITH A 2 MM DRILL. A QUANTITY OF 3 AR-8827L-12, LOW PROFILE LOCKING SCREW(S) (LOT: 031731 // LOT: 10158067 // LOT: 185363) WOULD NOT FULLY ENGAGE INTO THE FIBULA PLATE. THE SURGEON BACKED OUT EACH SCREW A FEW TURNS, AND RETRIED AGAIN. HOWEVER, ALL THREE SCREWS WOULD NOT ENGAGE THE THREADS. AN AR-8827L-14 (LOT: 031725) WAS PLACED AND SCREWED INTO THE HOLE. THE THREADS ON THE SCREW WOULD NOT FULLY ENGAGE INTO THE PLATE FULLY. THE SCREW WAS BACKED OUT A COUPLE OF TURNS AND RETRIED. HOWEVER, THE SCREW STILL WOULD NOT ENGAGE IN THE PLATE. THE AR-8827L-14 WAS REMOVED FROM THE PLATE AND A SECOND AR-8827L-14 FROM THE SAME LOT WAS TRIED. HOWEVER, THE SAME ISSUE OCCURRED AND THE SCREW WOULD NOT ENGAGE INTO THE PLATE FULLY. THE CASE WAS COMPLETED BY PLACING A BONE GRAFT AT THE NON UNION SITE AND THE LOCKING PLATE AND LOW PROFILE LOCKING SCREWS WERE PLACED ON THE FIBULA. A TOTAL OF 7 SCREWS WERE IMPLANTED WITH THE LOCKING PLATE. THE FOLLOWING ARTHREX PART AND LOT NUMBERS WERE USED IN THE REVISION SURGERY ON (B)(6) 2018: AR-8943BL-06, AR-8827L-12 (QTY. 3)- LOT: 031731 // LOT: 10158067 // LOT: 185363. AR-8827L-14 (QTY. 2)- LOT: 031725. ADDITIONAL INFORMATION RECEIVED 06/14/2018: THE REP CONFIRMED THAT ALL ARTHREX PARTS THAT WERE IMPLANTED DURING THE ORIGINAL (B)(6) 2017 SURGERY WERE EXPLANTED DURING THE (B)(6) 2017 REVISION SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    466938 LOCK DISTAL FIBULA PLT,SS LFT,5H PLATE, FIXATION, BONE HRS ARTHREX, INC. LOCK DISTAL FIBULA PLT,SS LFT,5H UNK 00888867052529

    Patients

    Seq Age Sex Outcome Treatment
    1 Other