BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOCKET WRENCH FOR VEPTR NUT

    MDR report key: 20071711 · Received August 26, 2024

    Report

    Report Number
    8030965-2024-10380
    Event Type
    Malfunction
    Date Received
    August 26, 2024
    Date of Event
    July 30, 2024
    Manufacturer
    SYNTHES GMBH
    Product Code
    HXC
    UDI-DI
    07611819353763
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, 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. H11 ADDITIONAL NARRATIVE: DEVICE HISTORY REVIEW: PART # 03.641.004. SYNTHES LOT # J001347-07. SUPPLIER LOT # J001347-07. RELEASE TO WAREHOUSE DATE: 05 NOV 2020. SUPPLIER : AVALIGN TECHNOLOGIES-NEMCOMED. NO NCRS 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. 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

    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. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. H11 ADDITIONAL NARRATIVE: D4: UDI: (SERIAL NUMBER) (B)(6). D9: COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. E3: REPORTER IS A J&J SALES REPRESENTATIVE. 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# 03.641.004. SYNTHES LOT # J001347. SUPPLIER LOT# J001347. RELEASE TO WAREHOUSE DATE: NOV-05-2020. SUPPLIER: (B)(4). NO NCRS WERE GENERATED DURING PRODUCTION. DEVICE HISTORY 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. 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 (B)(6), 2024, DURING ROUTINE INCOMING INSPECTION OF A LOANER SET, IT WAS OBSERVED THAT THE N.M HANDLE, WAS FOUND TO BE OUT OF DRAWING SPECIFICATION. THE DRAWING SPECIFICATION OF THE TORQUE TESTED HIGH. THERE WAS NO KNOWN PATIENT OR HOSPITAL INVOLVEMENT. ALL INFORMATION REGARDING THIS EVENT HAS BEEN REPORTED. THERE WAS NO PATIENT CONSEQUENCES. THIS REPORT IS FOR ONE (1) SOCKET WRENCH FOR VEPTR NUT. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1218726 SOCKET WRENCH FOR VEPTR NUT WRENCH HXC SYNTHES GMBH 07611819353763

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown