BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRIVING CAP

    MDR report key: 16572979 · Received March 20, 2023

    Report

    Report Number
    8030965-2023-03378
    Event Type
    Malfunction
    Date Received
    March 20, 2023
    Date of Event
    December 28, 2022
    Manufacturer
    SYNTHES GMBH
    Product Code
    LXH
    UDI-DI
    10886982297389
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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. THE INITIAL REPORTER IS A SYNTHES EMPLOYEE. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED ARTICLE LOT AND NO NON-CONFORMANCES WERE IDENTIFIED. PART# 03.043.028. LOT # 21456205. MANUFACTURING SITE: WERK SELZACH LOGISTIK. RELEASE TO WAREHOUSE DATE: 27 JAN 2022. SUPPLIER: BÄCHLER FEINTECH AG. EXPIRATION DATE: N/A. THE PRODUCT WAS RETURNED TO DEPUY SYNTHES FOR EVALUATION. THE DEPUY SYNTHES TEAM CONDUCTED A VISUAL INSPECTION OF THE RETURNED DEVICE. VISUAL ANALYSIS OF THE RETURNED SAMPLE REVEALED THAT DRIVING CAP HAD NO VISUAL OR COSMETIC DEFECT. A DIMENSIONAL INSPECTION FOR THE DRIVING CAP WAS NOT PERFORMED AS IS NOT APPLICABLE TO THE COMPLAINT CONDITION. A FUNCTIONAL TEST WAS PERFORMED AND THE PULL BUTTON WOULD WORK SMOOTHLY, HOWEVER IT WAS NOT POSSIBLE DISASSEMBLE THE DRIVING CAP FROM THE MATING DEVICE (INSERTION HANDLE/ RADIOLUCENT LONG). THE COMPLAINT CONDITION WAS ABLE TO BE REPLICATED. AS PART OF DEPUY SYNTHES QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. THE OVERALL COMPLAINT WAS CONFIRMED AS THE OBSERVED CONDITION OF THE DRIVING CAP WOULD CONTRIBUTE TO THE COMPLAINED DEVICE ISSUE. THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE COMPLAINT CONDITION AND HENCE THE ROOT CAUSE CANNOT BE DETERMINED. 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 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) 2022, THE INSERTION HANDLE WAS STRUCK DURING THE PROCEDURE AND APPEARS TO HAVE DEFORMED THE DRIVING DEVICE, PREVENTING IT FROM BEING REMOVED FROM THE INSERTION HANDLE AT THE CONCLUSION OF THE PROCEDURE. IT WAS UNKNOWN IF THERE WAS ANY SURGICAL DELAY OR PATIENT CONSEQUENCES. THIS REPORT IS FOR A DRIVING CAP. THIS IS REPORT 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2007510 DRIVING CAP ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH SYNTHES GMBH 03.043.028 21456205 10886982297389

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown INSERTION HANDLE/ RADIOLUCENT LONG