BEUDAMED
    FDA Adverse Event Injury Summary report: N

    4.9MM TI LOCKING BOLT 32MM

    MDR report key: 10250444 · Received July 9, 2020

    Report

    Report Number
    8030965-2020-04737
    Event Type
    Injury
    Date Received
    July 9, 2020
    Report Date
    June 24, 2020
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HTY
    UDI-DI
    07611819043107
    PMA / PMN Number
    K970733
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL DEVICE PRODUCT CODES: JDW, JDS, JDN, AND HSB. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/ INVESTIGATION. REPORTER IS A SYNTHES EMPLOYEE. PART: 459.320, LOT: 5945184, MANUFACTURING SITE: (B)(4), RELEASE TO WAREHOUSE DATE: FEBRUARY 14, 2018. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCE'S WERE IDENTIFIED. 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. (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

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THAT THE PATIENT EXPERIENCED A POST-OP FRACTURE. THE PATIENT SUFFERED FROM FRACTURE ON HIS RIGHT THIGH ON (B)(6) 2020. PREVIOUSLY ON (B)(6) 2019, THE PATIENT UNDERWENT THE SURGERY OF REDUCTION OF RIGHT SUBTROCHANTERIC FRACTURE AND INTERNAL FIXATION WITH INTRAMEDULLARY NAIL. THE PATIENT UNDERWENT THE SURGERY OF RIGHT FEMORAL INCISION AND INTRAMEDULLARY NAIL REMOVAL, AND THEN INTRAMEDULLARY NAIL FIXATION OF RIGHT FEMORAL FRACTURE ON (B)(6) 2020. CONCOMITANT DEVICE REPORTED: TFN NAIL (PART NUMBER UNKNOWN, LOT UNKNOWN, QUANTITY 1), TFN HELICAL BLADE (PART NUMBER UNKNOWN, LOT UNKNOWN, QUANTITY 1), TFN END CAP (PART NUMBER UNKNOWN, LOT UNKNOWN, QUANTITY 1), LOCKING SCREW (PART NUMBER UNKNOWN, LOT UNKNOWN, QUANTITY UNKNOWN). THIS REPORT INVOLVES ONE (1) 4.9MM TI LOCKING BOLT 32MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    713387 4.9MM TI LOCKING BOLT 32MM PIN,FIXATION,SMOOTH HTY OBERDORF SYNTHES PRODUKTIONS GMBH 5945184 07611819043107

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention UNK - END CAPS: TFN| UNK - NAIL HEAD ELEMENTS: TFN HELICAL BLADE| UNK - NAILS: TFN| UNK - SCREWS: LOCKING