BEUDAMED
    FDA Adverse Event Injury Summary report: N

    10MM TI CANN TIBIAL NAIL-EX W/PROX BEND 375MM-STERILE

    MDR report key: 12204806 · Received July 21, 2021

    Report

    Report Number
    9612488-2021-00007
    Event Type
    Injury
    Date Received
    July 21, 2021
    Report Date
    June 22, 2021
    Manufacturer
    SYNTHES PRODUKTIONS GMBH
    Product Code
    JDS
    UDI-DI
    10886982095268
    PMA / PMN Number
    K040762
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. MANUFACTURING LOCATION: (B)(4). MANUFACTURING DATE: 25-OCT-2019. EXPIRATION DATE: 30-SEP-2028. PART NUMBER: 04.034.455S, 10MM TI CANN TIBIAL NAIL - EX W/PROX BEND 375MM ¿ STERILE. LOT NUMBER: 21P2929 (STERILE). LOT QUANTITY: 6. PRODUCTION ORDER TRAVELER MET ALL INSPECTION ACCEPTANCE CRITERIA. INSPECTION SHEET, IN-PROCESS / INSPECT DIMENSIONAL / FINA MET ALL INSPECTION ACCEPTANCE CRITERIA. PACKAGING LABEL LOG (PLL) WAS REVIEWED AND DETERMINED TO BE CONFORMING. PACKAGING BOM WAS REVIEWED AND DETERMINED TO BE CONFORMING WITH NO DEVIATIONS TO NORMAL PACKAGING IDENTIFIED. SCN 16813 BY ETHICON (ABQ) WAS REVIEWED AND DETERMINED TO BE CONFORMING. THIS LOT MET ALL DIMENSIONAL, VISUAL, STERILITY AND PACKAGING CRITERIA AT THE TIME OF RELEASE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. COMPONENT PART(S) REVIEWED: COMPONENT PARTS WERE NOT REVIEWED AS THE REPORTED COMPLAINT CONDITION OF ¿REMOVAL DUE TO INFECTED UNION¿ DOES NOT INDICATE BREAKAGE OF THE NAIL. THEREFORE, REVIEW OF THE RAW MATERIALS WOULD NOT BE PERTINENT TO THE REPORTED COMPLAINT CONDITION. MANUFACTURING LOCATION: (B)(4). MANUFACTURING DATE: 25-OCT-2019. EXPIRATION DATE: 30-SEP-2028. PART NUMBER: 04.034.455S, 10MM TI CANN TIBIAL NAIL - EX W/PROX BEND 375MM ¿ STERILE. LOT NUMBER: 21P2929 (STERILE). LOT QUANTITY: 6. PRODUCTION ORDER TRAVELER MET ALL INSPECTION ACCEPTANCE CRITERIA. INSPECTION SHEET, IN-PROCESS / INSPECT DIMENSIONAL / FINAL MET ALL INSPECTION ACCEPTANCE CRITERIA. PACKAGING LABEL LOG (PLL) LPPF WAS REVIEWED AND DETERMINED TO BE CONFORMING. PACKAGING BOM WAS REVIEWED AND DETERMINED TO BE CONFORMING WITH NO DEVIATIONS TO NORMAL PACKAGING IDENTIFIED. SCN 16813 BY ETHICON (ABQ) WAS REVIEWED AND DETERMINED TO BE CONFORMING. THIS LOT MET ALL DIMENSIONAL, VISUAL, STERILITY AND PACKAGING CRITERIA AT THE TIME OF RELEASE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. COMPONENT PART(S) REVIEWED: COMPONENT PARTS WERE NOT REVIEWED AS THE REPORTED COMPLAINT CONDITION OF ¿REMOVAL DUE TO INFECTED UNION¿ DOES NOT INDICATE BREAKAGE OF THE NAIL. THEREFORE, REVIEW OF THE RAW MATERIALS WOULD NOT BE PERTINENT TO THE REPORTED COMPLAINT CONDITION. (B)(4). 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

    IT WAS REPORTED THAT ON (B)(6) 2021 THAT THE PATIENT UNDERWENT THE REMOVAL OF IMPLANTS DUE TO AN INFECTED NONUNION OF THE RIGHT TIBIA. ALL DEVICES WERE REMOVED SUCCESSFULLY. THERE WERE NO BROKEN IMPLANTS. THERE WAS NO SURGICAL DELAY AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE ORIGINAL DATE OF IMPLANT WAS (B)(6) 2020. THIS REPORT IS FOR ONE (1) 10MM TI CANN TIBIAL NAIL-EX W/PROX BEND 375MM-STERILE. THIS IS REPORT 6 OF 6 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1100880 10MM TI CANN TIBIAL NAIL-EX W/PROX BEND 375MM-STERILE NAIL, FIXATION, BONE JDS SYNTHES PRODUKTIONS GMBH 04.034.455S 21P2929 10886982095268

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention