BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIOLUCENT INSERTION HANDLE FRN

    MDR report key: 13949841 · Received March 30, 2022

    Report

    Report Number
    1719045-2022-00012
    Event Type
    Malfunction
    Date Received
    March 30, 2022
    Manufacturer
    MONUMENT DEPUY SYNTHES PRODUCTS INC
    Product Code
    HSB
    UDI-DI
    10886982271051
    PMA / PMN Number
    K172157
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL REPORTER IS SYNTHES SALES REPRESENTATIVE. 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 THERE WAS NO DAMAGE OR DEFECTS WITH THE RADIOLUCENT INSERTION HANDLE FRN. A DIMENSIONAL INSPECTION FOR THE RADIOLUCENT INSERTION HANDLE FRN WAS UNABLE TO BE PERFORMED DUE AS NO DEFECTS WERE FOUND AFTER VISUAL EXAMINATION. A FUNCTIONAL TEST WAS NOT CONDUCTED AS THE MATING DEVICE WAS NOT AVAILABLE. AS PART OF DEPUY SYNTHES QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. THE OVERALL COMPLAINT WAS NOT CONFIRMED AS THE OBSERVED CONDITION OF THE RADIOLUCENT INSERTION HANDLE FRN WAS FOUND TO HAVE NO DAMAGE OR DEFECTS. NO DEFINITIVE ROOT CAUSE COULD BE DETERMINED. THERE WAS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE CONTRIBUTED TO THE COMPLAINT. 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: 03.033.001, LOT NUMBER: L750725, RELEASE TO WAREHOUSE DATE: 19 APR 2018, MANUFACTURED BY (B)(4). 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON AN UNKNOWN DATE, IT WAS DISCOVERED THAT THE DRIVING CAP COULD NOT BE THREADED INTO THE RADIOLUCENT INSERTION HANDLE. NO SURGICAL OR PATIENT INVOLVEMENT REPORTED. THIS REPORT IS FOR ONE (1) RADIOLUCENT INSERTION HANDLE FRN. THIS IS REPORT 3 OF 6 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    698839 RADIOLUCENT INSERTION HANDLE FRN ROD, FIXATION, INTRAMEDULLARY HSB MONUMENT DEPUY SYNTHES PRODUCTS INC 03.033.001 L750725 10886982271051

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown DRIVING CAP/THREADED| DRIVING CAP/THREADED| DRIVING CAP/THREADED| RADIOLUCENT INSERTION HANDLE FRN| RADIOLUCENT INSERTION HANDLE FRN| RADIOLUCENT INSERTION HANDLE FRN