BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOLDSLEEVE W/WINGSCR L55 I-Ø 6 F/LARGE-D

    MDR report key: 18661234 · Received February 7, 2024

    Report

    Report Number
    8030965-2024-02115
    Event Type
    Malfunction
    Date Received
    February 7, 2024
    Manufacturer
    SYNTHES GMBH
    Product Code
    FZX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    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. H3, H4, H6 INVESTIGATION SUMMARY SERVICE AND REPAIR EVALUATION: THE CUSTOMER REPORTED THAT ON (B)(6) 2024, THE THREADS OF WING NUT BROKE OFF INSIDE AND WING NUT THREADS ARE STRIPPED. THE REPAIR TECHNICIAN REPORTED THAT DEVICE HAD MISSING WING SCREW AND COSMETIC TEST FAILED. WARRANTY REPLACED IS THE REASON FOR REPAIR. THE ITEM IS NOT REPAIRABLE PER THE INSPECTION SHEET. THE CAUSE OF THE ISSUE IS UNKNOWN. THE ITEM WILL BE FORWARDED TO CUSTOMER QUALITY. THE EVALUATION WAS CONFIRMED. DEVICE HISTORY PART # 394.45, SYNTHES LOT # 2021318, SUPPLIER LOT # 2021318, RELEASE TO WAREHOUSE DATE: 04 OCT 2007, SUPPLIER: (B)(4), NO NCRS WERE GENERATED DURING PRODUCTION. 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 · 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. H10 ADDITIONAL NARRATIVE: B3: UNKNOWN EVENT DATE. E1: INITIAL REPORTER IS J&J COMPANY REPRESENTATIVE. H3, H6: THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR 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

    NO OPERATION INVOLVED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON JANUARY 25, 2024, THE THREADS OF WING NUT BROKE OFF INSIDE AND WING NUT THREADS ARE STRIPPED. THERE WAS NO PATIENT INVOLVEMENT. IT IS UNKNOWN WHEN THE EVENT OCCURRED. THIS REPORT IS FOR ONE HOLDSLEEVE W/WINGSCR L55 I-Ø 6 F/LARGE-D FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1907712 HOLDSLEEVE W/WINGSCR L55 I-Ø 6 F/LARGE-D GUIDE, SURGICAL, INSTRUMENT FZX SYNTHES GMBH 2021318

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown