BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2.7MM VA-LCP LATERAL DISTAL FIBULA PLATE/7 HOLES/LEFT

    MDR report key: 7053515 · Received November 22, 2017

    Report

    Report Number
    2939274-2017-50031
    Event Type
    Injury
    Date Received
    November 22, 2017
    Report Date
    October 27, 2017
    Manufacturer
    WRIGHTS LANE : SYNTHES USA PRODUCTS LLC
    Product Code
    HRS
    UDI-DI
    10886982038968
    PMA / PMN Number
    K120854
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PART NUMBER: 02.118.409, SYNTHES LOT NUMBER: 9983848: RELEASE TO WAREHOUSE DATE: JANUARY 21, 2016. MANUFACTURED BY SYNTHES (B)(4). NO NON-CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT, AND ANY SUBCOMPONENTS, WHICH WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. A PRODUCT INVESTIGATION WAS COMPLETED: THE DEVICE WAS NOT RETURNED FOR INVESTIGATION; ONLY AN X-RAY WAS PROVIDED. A VISUAL INSPECTION VIA THE PROVIDED X-RAY AND DRAWING REVIEW WERE PERFORMED AS PART OF THIS INVESTIGATION. NO DEFECTS OF DEFICIENCIES IN THE DEVICE WERE OBSERVED ON THE X-RAY. THUS, IT IS CONFIRMED THAT NO PRODUCT PROBLEM WAS IDENTIFIED. DURING THE INVESTIGATION NO PRODUCT ISSUES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. NO NEW MALFUNCTIONS WERE OBSERVED DURING THE COURSE OF THIS INVESTIGATION. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    (B)(6). ADDITIONAL PRODUCT CODE: HWC. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    THIS IS REPORT 3 OF 6 FOR (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT HAD A MOTOR VEHICLE ACCIDENT ON AN UNKNOWN DATE AND SUBSEQUENTLY SUFFERED A FRACTURED TIBIA AND FIBULA. HE WAS IMPLANTED WITH A TIBIAL NAIL AND LOCKING DISTAL FIBULA PLATE IN (B)(6) 2016. PATIENT NOW PRESENTS WITH AN INFECTED NONUNION. A REVISION SURGERY OCCURRED ON (B)(6) 2017. ONE (1) FIBULA PLATE, THREE (3) UNKNOWN 5 MM LOCKING SCREWS, FOUR (4) UNKNOWN 2.7 MM VARIABLE ANGLE LOCKING SCREWS AND THREE (3) UNKNOWN 2.7 MM CORTEX SCREWS ON FIBULA WERE REMOVED/EXPLANTED AND THE TIBIAL NAIL WAS EXTRACTED. AN OSTEOTOMY WAS DONE ON THE TIBIA AND FIBULA. AN ANTIBIOTIC CEMENT COATED NAIL WAS INSERTED IN PATIENT FOR INFECTION. THERE WAS NO SURGICAL DELAY, HOWEVER, THE SURGEON HAD TO TREPHINE AN UNKNOWN BROKEN SCREW AS IT WAS DIFFICULT TO REMOVE. AN ADDITIONAL X-RAY WAS REQUIRED TO REMOVE THE BROKEN SCREW. THIS SCREW WAS IN THE PROXIMAL PORTION OF NAIL AND WAS BROKEN PRIOR TO SURGERY. ALL SCREW FRAGMENTS WERE REMOVED. THE REMAINDER OF THE PROCEDURE WAS COMPLETED SUCCESSFULLY. PATIENT OUTCOME REPORTED AS OKAY. THIS IS REPORT 3 OF 5 FOR (B)(4).

    Description of Event or Problem · 1

    THE PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2018 FOR REMOVAL OF AN ANTIBIOTIC NAIL SPACER AND INSERTION OF A TIBIAL NAIL FOR FIXATION. PATIENT ALSO HAD TO BE BONE GRAFTED USING AUTOLOGOUS ILLIAC CREST BONE GRAFT AND ALLOGRAFT CANCELLOUS CHIPS. THIS PROCEDURE WAS PART OF THE TREATMENT PLAN. THE ANTIBIOTIC NAIL HAD BEEN PREVIOUSLY IMPLANTED TO HELP WITH THE INFECTION. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND THE PATIENT IS DOING OKAY. CONCOMITANT DEVICES REPORTED: ANTIBIOTIC CEMENT COATED NAIL (PART/LOT UNKNOWN, QUANTITY 1)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    832545 2.7MM VA-LCP LATERAL DISTAL FIBULA PLATE/7 HOLES/LEFT PLATE, FIXATION, BONE HRS WRIGHTS LANE : SYNTHES USA PRODUCTS LLC 02.118.409 9983848 10886982038968

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Required Intervention