BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSERT-HANDLE F/ETN RADIOLUC SHORT

    MDR report key: 12820305 · Received November 16, 2021

    Report

    Report Number
    8030965-2021-09540
    Event Type
    Malfunction
    Date Received
    November 16, 2021
    Date of Event
    October 23, 2021
    Report Date
    October 23, 2021
    Manufacturer
    SYNTHES GMBH
    Product Code
    LXH
    UDI-DI
    07611819184886
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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- THE COMPLAINT DEVICE (INSERT-HANDLE F/ETN RADIOLUC SHORT) WAS RETURNED FOR INVESTIGATION. AFTER PHYSICAL REVIEW OF THE PART, IT WAS POSSIBLE TO CONFIRM THE ALLEGATION. IT IS NOT POSSIBLE TO DISASSEMBLE DEVICES. PER SURGICAL TECHNIQUE 097637-200428 IT WAS CONFIRMED PRODUCT CODE 03.010.013 (INSERT-HANDLE F/ETN RADIOLUC SHORT) IS NOT INTENDED TO COMPLETE MATING OPERATION WITH 03.010.047 (CONNEC L141 F/INSERTION HANDLE). NO DESIGN ISSUES WERE OBSERVED DURING THE DOCUMENT/ SPECIFICATION REVIEW. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST MARKET SAFETY SURVEILLANCE ACTIVITIES. DEVICE HISTORY LOT : PART NUMBER: 03.010.013, LOT NUMBER: 40P7369, MANUFACTURING SITE: HAEGENDORF, RELEASE TO WAREHOUSE DATE: 20 APRIL 2020. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES 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.

    Additional Manufacturer Narrative · 0

    REPORTER IS A J&J EMPLOYEE. 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 · 0

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, THE INSERTION HANDLE WAS FOUND TO BE STUCK IN THE DRIVING CAP WITH HANDLE ADAPTER. THE TWO INSTRUMENTS COULD NOT BE DISASSEMBLED. THE ISSUE WAS FOUND DURING LOAN KIT INSPECTION. THERE WAS NO KNOWN PATIENT INVOLVEMENT. THERE IS NO FURTHER INFORMATION AVAILABLE. THIS REPORT IS FOR ONE (1) INSERT-HANDLE F/ETN RADIOLUC SHORT. THIS IS REPORT 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1720783 INSERT-HANDLE F/ETN RADIOLUC SHORT MISC ORTHO SURGICAL INSTR LXH SYNTHES GMBH 40P7369 07611819184886

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown CONNEC L141 F/INSERTION HANDLE