BEUDAMED
    FDA Adverse Event Injury Summary report: N

    4.9MM TI LOCKING BOLT 44MM

    MDR report key: 8307304 · Received February 5, 2019

    Report

    Report Number
    8030965-2019-60666
    Event Type
    Injury
    Date Received
    February 5, 2019
    Report Date
    November 12, 2018
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HTY
    UDI-DI
    07611819043169
    PMA / PMN Number
    K970733
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    PHYSICIAN

    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. INVESTIGATION SUMMARY ACCORDING TO THE PICTURES/PHOTOS IT CAN BE SEEN THAT THE BOLT IS IN USED CONDITION, BUT NOTHING IS BROKEN AND IS POSSIBLY STILL INTACT. DEVICE HISTORY LOT PART: 459.440, LOT: 5942055, MANUFACTURING SITE: SALZBURG, RELEASE TO WAREHOUSE DATE: 07.MARCH 2017. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER 5942055, 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 DEVICE PROCODES: JDW, JDS, JDN, HSB. DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. (B)(4). PRODUCT WAS NOT RETURNED. DEVICE HISTORY RECORDS REVIEW HAS BEEN REQUESTED. 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 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 AN UNKNOWN DATE, THE PATIENT WAS TREATED FOR SUBTROCATERIC FRACTURE WITH PROXIMAL FEMORAL NAIL ANTIROTAION (PFNA) NAIL, AFTER TWELVE (12) MONTHS OF NO HEALING, THE NAIL BROKE AND STILL NO UNION. THE PATIENT UNDERWENT REVISION TO 95 DEGREES ANDRE BLADE PLATE AND BONE GRAFT ON (B)(6) 2018. THE SURGERY WAS COMPLETED BY USING A PLIER TO REMOVED THE BROKEN IMPLANTS WITHOUT FINISHING THE STEP. INVESTIGATION FOR LOW-GRADE INFECTION WAS CONFIRMED. THERE WAS NO DELAY DURING THE PROCEDURE. THE PATIENT OUTCOME REPORTED IS ROUTINE. THIS REPORT IS FOR ONE (1) LOCKING BOLT. THIS IS REPORT 3 OF 4 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    98125 4.9MM TI LOCKING BOLT 44MM PIN,FIXATION,SMOOTH HTY OBERDORF SYNTHES PRODUKTIONS GMBH 5942055 07611819043169

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention