BEUDAMED
    FDA Adverse Event Injury Summary report: N

    4.9MM TI LOCKING BOLT 40MM

    MDR report key: 8457737 · Received March 27, 2019

    Report

    Report Number
    8030965-2019-62290
    Event Type
    Injury
    Date Received
    March 27, 2019
    Report Date
    March 4, 2019
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HTY
    UDI-DI
    07611819043145
    PMA / PMN Number
    K970733
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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. RECEIVED DEVICE WAS VISUALLY INSPECTED AND NO DEFECT WERE FOUND WHICH MIGHT BE LEADING TO REPORTED CONDITION. OVERALL SURFACE WEAR WAS PRESENT DUE TO REMOVAL PROCESS. NO DEFECTS WERE FOUND DURING INVESTIGATION WHICH WOULD CONTRIBUTE TO THE EVENT. DURING THE INVESTIGATION, NO PRODUCT DESIGN AND MANUFACTURING ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE EVENT. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST MARKET SAFETY SURVEILLANCE ACTIVITIES. THEREFORE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTIVE ACTION IS PROPOSED. DEVICE HISTORY LOT: PART: 459.400, LOT: 5941577, MANUFACTURING SITE: SALZBURG, RELEASE TO WAREHOUSE DATE: 12.JAN.2017. 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.

    Additional Manufacturer Narrative · 1

    ADDITIONAL PROCODE: JDW, JDS, JDN, HSB. IMPLANT DATE: DATE OF IMPLANTATION IS AN UNKNOWN DATE IN (B)(6) 2017. DEVICE EVALUATED BY MFR: THE DEVICE WAS RECEIVED, THE INVESTIGATION IS IN PROGRESS, NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING THIS REPORT. (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 (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2018, THE PATIENT UNDERWENT A REMOVAL PROCEDURE DUE TO PSEUDOARTHROSIS. PATIENT WAS INITIALLY IMPLANTED WITH A TITANIUM (TI) CANNULATED TROCHANTERIC FIXATION NAIL (TFN), FEMORAL NECK SCREW, AND LOCKING BOLT TO TREAT A TROCHANTERIC BREAKAGE IN (B)(6) 2017. A SURGICAL DELAY OF UNKNOWN DURATION OCCURRED. PATIENT STATUS IS UNKNOWN. THIS REPORT IS FOR A 4.9MM TI LOCKING BOLT 40MM. THIS IS REPORT 3 OF 3 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    251586 4.9MM TI LOCKING BOLT 40MM PIN, FIXATION, SMOOTH HTY OBERDORF SYNTHES PRODUKTIONS GMBH 5941577 07611819043145

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention