BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHAFT FOR 90 SCREWDRIVER

    MDR report key: 11563075 · Received March 24, 2021

    Report

    Report Number
    8030965-2021-02259
    Event Type
    Malfunction
    Date Received
    March 24, 2021
    Report Date
    February 24, 2021
    Manufacturer
    SYNTHES GMBH
    Product Code
    HXX
    UDI-DI
    07611819187474
    PMA / PMN Number
    K082649
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). 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. H3, H4, H6: DEVICE HISTORY LOT PART: 03.505.003, LOT: 8190939, MANUFACTURING SITE: SELZACH, SUPPLIER: (B)(4), RELEASE TO WAREHOUSE DATE: 11.JUL.2019. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. INVESTIGATION SUMMARY: IT WAS REPORTED THAT THIS WAS AN UNKNOWN PROCEDURE PERFORMED ON (B)(6) 2021. IN ORDER TO CLEANSE AND STERILIZE THE SHAFT, THEY DISASSEMBLED THE COMPONENTS ON (B)(6). NEXT, THEY TRIED TO REASSEMBLE THE COMPONENTS, BUT THE LID COMPONENT WAS NOT ABLE TO BE CONNECTED TO A COUNTERPART. A REPLACEMENT WAS PREPARED FOR THE UPCOMING PROCEDURE ON (B)(6). NO FURTHER INFORMATION IS AVAILABLE. THE RETURNED PRODUCT INFORMATION WAS FORWARDED TO MANUFACTURER FOR EVALUATION. DIENER AG THEN CONDUCTED EXAMINATION OF THE RETURNED DEVICE. H6: VISUAL ANALYSIS OF THE RETURNED SAMPLE DETERMINED THAT THE BEARING SEAT ON THE GEAR IS DAMAGED/DEFORMED AND THE THREAD ON THE SHAFT/HEAD IS DAMAGED/DEFORMED. BECAUSE OF THE DAMAGE AND THE MIX-UP, A FUNCTION TEST IS NOT POSSIBLE ANYMORE. THE INVESTIGATION HAS SHOWN THAT THE CAUSE OF COMPLAINED MALFUNCTION IS A POST-MANUFACTURING CAUSED USE RELATED DAMAGE AT THE DEVICE, THEREFORE NO DIMENSIONAL INSPECTION IS NEEDED. A MIX-UP OF THE BATCH NUMBERS FOR THE INDIVIDUAL COMPONENTS, LOT SHAFT COMPLETE 8190939, LOT COVER 8200812, LOT SHAFT 8192438. OBVIOUSLY, THERE WAS A MIX-UP WITH THE END CUSTOMER. THIS MEANS THAT THE VERIFIABLE DELIVERY STATUS AND FUNCTIONALITY ARE NO LONGER GUARANTEED. AS PART OF DIENER AG¿S QUALITY PROCESS ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. ADDITIONAL COMPLAINT INFORMATION MONITORING FOR POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AS PART OF POST MARKET SURVEILLANCE. 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

    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 ON (B)(6) 2021, WHEN STERILIZING THE SHAFT, THE COMPONENTS WERE DISASSEMBLED AND DURING REASSEMBLY, THE LID COMPONENT WAS NOT ABLE TO BE CONNECTED TO THE COUNTERPART. A REPLACEMENT WAS USED FOR THE UNKNOWN PROCEDURE ON (B)(6) 2021. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) SHAFT FOR 90° SCREWDRIVER THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    463050 SHAFT FOR 90 SCREWDRIVER SCREWDRIVERS HXX SYNTHES GMBH 8190939 07611819187474

    Patients

    Seq Age Sex Outcome Treatment
    1