BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 16208926 · Received January 19, 2023

    Report

    Report Number
    8030965-2023-00661
    Event Type
    Malfunction
    Date Received
    January 19, 2023
    Date of Event
    December 5, 2022
    Manufacturer
    SYNTHES GMBH
    Product Code
    FZX
    UDI-DI
    07611819025752
    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. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. ADDITIONAL NARRATIVE: INITIAL REPORTER OCCUPATION: REPORTER IS A J&J SALES REPRESENTATIVE. PART # 394.45. SYNTHES LOT # 2021318. SUPPLIER LOT # 2021318. RELEASE TO WAREHOUSE DATE: 04 OCT 2007. SUPPLIER: (B)(4). NO NON CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT, AND ANY SUB-COMPONENTS, WHICH WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE CUSTOMER REPORTED THE ITEMS HAD STUCK KEYS. THE REPAIR TECHNICIAN REPORTED CROSS THREADED. THREADS STRIPPED IS THE REASON FOR REPAIR. THE ITEM IS NOT REPAIRABLE PER THE INSPECTION SHEET. THE CAUSE OF THE ISSUE IS THREADS STRIPPED. THE ITEM WILL BE FORWARDED TO CUSTOMER QUALITY. THE EVALUATION WAS CONFIRMED. 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 DEC 5, 2022, DURING INSPECTION, ITEMS HAD STUCK KEYS. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) HOLDSLEEVE W/WINGSCR L55 I-Ø 6 F/LARGE-D. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    363103 HOLDSLEEVE W/WINGSCR L55 I-Ø 6 F/LARGE-D GUIDE, SURGICAL, INSTRUMENT FZX SYNTHES GMBH 2021318 07611819025752

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown HOLDING SLEEVE 105MM