BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOLDING+DISTRACTION INSTR F/ECD

    MDR report key: 17193641 · Received June 23, 2023

    Report

    Report Number
    8030965-2023-08002
    Event Type
    Malfunction
    Date Received
    June 23, 2023
    Manufacturer
    SYNTHES GMBH
    Product Code
    FZX
    UDI-DI
    07611819162617
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHESE IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHESE HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHESE OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHESE, 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. H10 ADDITIONAL NARRATIVE: D9: COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. 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 HISTORY (LOT) PART:397.127 LOT:9424097 MANUFACTURING SITE: WERK HAGENDORF SUPPLIER: NA RELEASE TO WAREHOUSE DATE: 08 JUN 2015 EXPIRATION DATE:NA A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED ARTICLE LOT AND NO NON-CONFORMANCE'S 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.

    Description of Event or Problem · 0

    DEVICE REPORT FROM DEPUY SYNTHESE REPORTS AN EVENT IN UNITED KINGDOM AS FOLLOWS: I WOULD LIKE TO LOG SOME DAMAGED ITEMS AT JAMES COOK UNIVERSITY HOSPITAL WHICH WILL NEED REPLACING. I HAVE REQUESTED ALREADY BY FUNNEL OF LIFE ¿ FID NUMBERS INCLUDED BELOW. 2X EXPEDIUM MMSI FINAL TIGHTENER: - BUSINESS UNIT: DEPUY SYNTHESE SPINE - DATE J&J BECAME AWARE: (B)(6) 2023 - DATE OF EVENT: 05/06/2023 - NAME OF REPORTER: ANNA BRADSHAW (DPS), MR PETR JANOUS (NEURO SURGEON - JCUH) - BRAND NAME: EXPEDIUM 5.5 - PRODUCT NAME: MMSI FINAL TIGHTENER - PRODUCT CODE: 279712600 - LOT NUMBER: GM4660701, GM4133505 - BOTH FINAL TIGHTENER DRIVER-INTERFACES HAVE STRIPPED AND NO LONER ENGAGE IN THE SET SCREWS. NOT ABLE TO COMPLETE FINAL TIGHTENING USING THESE SHAFTS. NOTICED IN THEATRES YESTERDAY (B)(6) 2023. USED VIPER PRIME FINAL TIGHTENER CONSTRUCT ON THIS OCCASION, THEREFORE NO ADVERSE OUTCOMES TO THE PATIENT OR PROCEDURE, NO DELAYS INCURRED IN THEATRE. - ITEMS NOT AVAILABLE FOR RETURN ¿ DISPOSED OF. - NO LEGAL ACTION, NO ADVERSE EVENT. - FID: FID50865 1X ECD HOLDER F/ECD LOCKCLIP: - BUSINESS UNIT: DEPUY SYNTHESE SPINE - DATE J&J BECAME AWARE: 05/06/2023 - DATE OF EVENT: NOT KNOWN - NAME OF REPORTER: ANNA BRADSHAW (DPS), WILL FEATHERSTONE (STORES - JCUH) - BRAND NAME: ECD ¿ EXPANDABLE CORPECTOMY DEVICE - PRODUCT NAME: ECD HOLDER F/ECD LOCKCLIP/ HOLDING+DISTRACTION INSTRUMENT - PRODUCT CODE: 397.129 - LOT NUMBER: 9424097 - MECHANISM WITHIN THE INSTRUMENT IS BROKEN AND IS UNUSABLE. UNSURE WHEN THIS WAS NOTICED ¿ I WAS NOT PRESENT WHEN IT WAS NOTICED AND WAS ONLY MADE AWARE OF THE BROKEN INSTRUMENT YESTERDAY (B)(6) 2023. NO ADVERSE EVENTS DUE TO ALTERNATIVE PRODUCTS (DPS AND COMPETITOR BRANDS) AVAILABLE ON THE SHELF AND USED FOR CORPECTOMY PROCEDURES IN THE MEANTIME, OR ECD LOANED IN FROM ORTHOKIT. - ITEM NOT AVAILABLE FOR RETURN. - NO LEGAL ACTION, NO ADVERSE EVENT. - FID50957 (B)(4). IS RELATED TO (B)(4).. THIS REPORT IS FOR ONE (1) HOLDING+DISTRACTION INSTR F/ECD. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4)..

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1822026 HOLDING+DISTRACTION INSTR F/ECD GUIDE, SURGICAL, INSTRUMENT FZX SYNTHES GMBH 9424097 07611819162617

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown