BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3.5MM TI LCP LOW BEND MEDIAL DSTL TIBIA PL/10H/LEFT/187MM

    MDR report key: 12683582 · Received October 22, 2021

    Report

    Report Number
    8030965-2021-08900
    Event Type
    Malfunction
    Date Received
    October 22, 2021
    Date of Event
    September 27, 2021
    Report Date
    September 27, 2021
    Manufacturer
    SYNTHES GMBH
    Product Code
    HRS
    UDI-DI
    07611819376113
    PMA / PMN Number
    K013248
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND 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 STERILE: PART #: 04.112.523S, LOT #: 8L13648, MANUFACTURING SITE: (B)(4), SUPPLIER: (B)(4), RELEASE TO WAREHOUSE DATE: 27 APR 2021, EXPIRATION DATE: 01 APR 2031. NON-STERILE: PART #: 04.112.523, LOT #: 97P8430, MANUFACTURING SITE: (B)(4), SUPPLIER: SYNTHES USA HQ, INC, RELEASE TO WAREHOUSE DATE: 31 MAR 2021. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. 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, THE PATIENT UNDERWENT THE OPEN REDUCTION INTERNAL FIXATION SURGERY FOR THE TIBIOFIBULAR DISTAL END FRACTURE WITH THE PLATE IN QUESTION. BEFORE THE SURGERY, THE SALES REP WHO VISITED THE HOSPITAL TO WITNESS THE SURGERY NOTICED THAT THE PLATES ORDERED WERE DIFFERENT ON THE RIGHT AND LEFT SIDES. THE SALES REPRESENTATIVE EXPLAINED THE SITUATION TO THE SURGEON, WHO DECIDED TO USE THE LEFT AND RIGHT REVERSED PLATE. THE PLATE WAS BENT AND USED IN THE SURGERY. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN 30 MINUTES DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) 3.5MM TI LCP LOW BEND MEDIAL DSTL TIBIA PL/10H/LEFT/187MM THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1583040 3.5MM TI LCP LOW BEND MEDIAL DSTL TIBIA PL/10H/LEFT/187MM PLATE, FIXATION, BONE HRS SYNTHES GMBH 8L13648 07611819376113

    Patients

    Seq Age Sex Outcome Treatment
    1