BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THREADED ROD FOR SMALL F-TOOL

    MDR report key: 8815931 · Received July 23, 2019

    Report

    Report Number
    8030965-2019-66495
    Event Type
    Malfunction
    Date Received
    July 23, 2019
    Report Date
    June 27, 2019
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    LXH
    UDI-DI
    07611819710597
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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. PART: 359.208. LOT: 2082086. MANUFACTURING SITE: BETTLACH. RELEASE TO WAREHOUSE DATE: JANUARY 27, 2004. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. VISUAL INSPECTION: THE DEVICE 359.208 WAS FOUND BROKEN AT IT'S THREADED TIP. THE BROKEN TIP IS STUCK INTO THE THREADED HOLE OF THE ARTICLE 359.207. BOTH DEVICES ARE IN VERY USED CONDITION. NO OTHER ISSUES WERE IDENTIFIED WITH THE RETURNED COMPONENTS OF THE DEVICE. DIMENSIONAL INSPECTION: DIMENSIONAL ANALYSIS COULD NOT BE PERFORMED AS RELEVANT FEATURES ARE DEFORMED THROUGH POST MANUFACTURING DAMAGE. CONCLUSION: OUR INVESTIGATION HAS SHOWN THAT THE COMPLAINT CONDITION IS CONFIRMED DUE TO THE RECEIVED CONDITION OF BOTH DEVICES. DUE TO THE HEAVY WEAR AND TEAR SIGNS, WE CAN ASSUME THAT THIS PRODUCTS WERE OFTEN AND INTENSIVE USED. WE DO SUPPOSE THAT THE DEVICE ENCOUNTERED UNINTENDED FORCES, SUCH AS BEING DROPPED ON THE FLOOR AND/ OR EXCESSIVE FORCE APPLICATION DURING ITS USE, WHICH FINALLY RESULTED IN THE BREAKAGE OF THE PIN. BY THE EVIDENCE THAT THIS DEVICE WAS USED SUCCESSFULLY OVER ITS 15 (FIFTEEN) YEARS OF LIFESPAN AND THE DAMAGES ARE CLEARLY CAUSED POST MANUFACTURING, WE CAN CONCLUDE THAT THE CAUSE OF FAILURE IS NOT DUE TO ANY MANUFACTURING NON-CONFORMANCES. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. 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

    INITIAL REPORTER IS COMPANY REPRESENTATIVE. THE DEVICE WAS RECEIVED, THE INVESTIGATION IS IN PROGRESS, NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING THIS REPORT. 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 DURING AN UNKNOWN SURGERY ON AN UNKNOWN DATE, THE THREADS OF A TOWER FOR F-TOOL AND THREADED ROD FOR F-TOOL WERE BROKEN. THE SURGERY WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY. PATIENT OUTCOME IS UNKNOWN. THIS IS REPORT 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    613708 THREADED ROD FOR SMALL F-TOOL MISC ORTHO SURGICAL INSTR LXH OBERDORF SYNTHES PRODUKTIONS GMBH 2082086 07611819710597

    Patients

    Seq Age Sex Outcome Treatment
    1