BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIMING ARM/ RADIOLUCENT

    MDR report key: 16407862 · Received February 21, 2023

    Report

    Report Number
    8030965-2023-02040
    Event Type
    Malfunction
    Date Received
    February 21, 2023
    Date of Event
    November 1, 2022
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWC
    UDI-DI
    07612334171108
    PMA / PMN Number
    K201336
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    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. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. ADDITIONAL DEVICE PRODUCT CODES: JDS COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. PART # 03.043.029, LOT # 2024221, MANUFACTURING SITE: WERK SELZACH, RELEASE TO WAREHOUSE DATE: 02 MAR 2021, SUPPLIER: CREATEC GMBH, A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED ARTICLE LOT AND NO NON-CONFORMANCES 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 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 · 0

    IT WAS REPORTED THAT ON (B)(6) 2022, THE ADVANCED TIBIAL NAIL AIMING ARM WAS MISSING THE NAIL. THE NAIL WAS RETIGHTENED TO THE HANDLE, AND THE SCREWS STILL MISSED THE NAIL. THE SCREWS WERE PLACED FREE HAND AND THE SURGERY WAS COMPLETED SUCCESSFULLY. THE MISSED SCREW WAS REMOVED. THERE WAS A DELAY OF 20 MINUTES. AFTER THE CASE, THE AIMING ARM WAS RE-EXAMINED AND IT WAS DETERMINED THAT THE CONNECTING BOLT WAS MALFUNCTIONING AND CAUSING THE DRILL AND SCREWS TO MISS THE NAIL. IT WAS POSSIBLY BENT, BUT WHEN USED, THE NAIL WASN'T TIGHTLY SECURED AS IT WAS WITH THE OTHER CONNECTING BOLT. AFTER CHECKING THE DEVICE, THE SURGEON THOUGHT IT WAS BEST IF THE AIMING ARM WERE REPLACED AS WELL. DEVICE MAY BE CAUSING THE AIMING ARM TO MISALIGN WITH THE NAIL CAUSING SCREWS TO MISS. THIS REPORT INVOLVES ONE AIMING ARM/ RADIOLUCENT. THIS IS REPORT 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    943214 AIMING ARM/ RADIOLUCENT SCREW, FIXATION, BONE HWC SYNTHES GMBH 2024221 07612334171108

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown CONNECTING SCREW/ CANNULATED LONG| UNK - NAILS: TIBIAL| UNK - SCREWS: TRAUMA