BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2.7MM/3.5MM TI LCP LAT DISTAL FIBULA PLATE 6H/LEFT/112MM

    MDR report key: 8796310 · Received July 16, 2019

    Report

    Report Number
    8030965-2019-66275
    Event Type
    Injury
    Date Received
    July 16, 2019
    Report Date
    June 20, 2019
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HRS
    UDI-DI
    07611819382831
    PMA / PMN Number
    K083213
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. DEVICE HISTORY LOT: PART# 04.112.143. LOT# H031766. MFG DATE: 10 FEBRUARY 2016. MFG LOCATION: ELMIRA SYNTHES USA. MANUFACTURING RECORD EVALUATION IS NOT REQUIRED AS THIS COMPLAINT IS RELATED TO POST-OPERATIVE INFECTION AND THE PART WAS DISTRIBUTED AS NON-STERILE. 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

    COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. (B)(4). THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING THIS REPORT. A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN REQUESTED. 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

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT A REOPERATION TO PARTIALLY FIXED THE LEFT ANKLE JOINT DUE TO AN INFECTION. INITIALLY, THE PATIENT HAD AN OPEN REDUCTION AND INTERNAL FIXATION (ORIF) SURGERY OF AN ANKLE JOINT DUE TO A FRACTURE OF THE LEFT THREE ANKLE USING A LOCKING COMPRESSION PLATE (LCP) LATERAL DISTAL FIBULA PLATE AND AN UNKNOWN SCREWS ON AN UNKNOWN DATE. HOWEVER, FIVE DAYS BEFORE THE REOPERATION, THE PATIENT GOT A COLD, WITH A MAXIMUM TEMPERATURE OF 38 DEGREES CELSIUS, FOLLOWED BY PAIN IN THE LEFT ANKLE, REDNESS OF THE SKIN, AND GRADUAL INCREASE OF PAIN. MOREOVER, A DAY BEFORE THE REOPERATION, THE PATIENT HAD A MASS AT THE WOUND AND THE SURROUNDING SKIN BECAME RED. THUS, THE LEFT ANKLE JOINT WAS PARTIALLY FIXED AND WAS REMOVED, DID AN INFECTION DEBRIDEMENT, AN ANTI-INFECTION WAS GIVEN, AND THE PATIENT WAS INSTRUCTED TO HAVE AN EXERCISE AND WAS MONITORED REGULARLY. THE PATIENT RECOVERED WELL. THIS COMPLAINT INVOLVES AN UNKNOWN NUMBER OF DEVICE/S. THIS REPORT IS 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    587987 2.7MM/3.5MM TI LCP LAT DISTAL FIBULA PLATE 6H/LEFT/112MM PLATE, FIXATION, BONE HRS OBERDORF SYNTHES PRODUKTIONS GMBH H031766 07611819382831

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Required Intervention