BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RAD AIMING ARM/FRN GREATER TROCHANTER

    MDR report key: 13524059 · Received February 14, 2022

    Report

    Report Number
    2939274-2022-00469
    Event Type
    Malfunction
    Date Received
    February 14, 2022
    Date of Event
    January 1, 2022
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HSB
    UDI-DI
    10886982271075
    PMA / PMN Number
    K172157
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL NARRATIVE: INITIAL REPORTER IS A SYNTHES EMPLOYEE. PART 03.033.003, LOT 83P1180: MANUFACTURING SITE: (B)(4). RELEASE TO WAREHOUSE DATE: FEBRUARY 16, 2021. A PRODUCT INVESTIGATION WAS COMPLETED: VISUAL ANALYSIS OF THE RETURNED SAMPLE REVEALED THAT ONE OF THE TABS OF THE LOCKING MECHANISM ON RAD AIMING ARM/FRN GREATER TROCHANTER WAS BROKEN, AND THE BROKEN PIECES WERE RETURNED. NO OTHER ISSUES WERE IDENTIFIED. THE DIMENSIONAL INSPECTION WAS NOT PERFORMED DUE TO POST MANUFACTURING DAMAGE. THE OBSERVED CONDITION OF THE RAD AIMING ARM/FRN GREATER TROCHANTER WAS CONSISTENT WITH A RANDOM COMPONENT FAILURE THAT MAY HAVE BEEN CAUSED BY EXPOSURE TO UNINTENDED FORCE. THE CURRENT AND MANUFACTURED TO DRAWINGS WERE REVIEWED. AS PART OF DEPUY SYNTHES QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. THE OVERALL COMPLAINT WAS CONFIRMED AS THE RAD AIMING ARM/FRN GREATER TROCHANTER WAS OBSERVED TO BE BROKEN. WHILE NO DEFINITIVE ROOT CAUSE COULD BE DETERMINED, IT IS PROBABLE THAT THE RAD AIMING ARM/FRN GREATER TROCHANTER BROKE DUE TO UNEXPECTED FORCES DURING USE. 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. 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, DURING A ROUTINE INCOMING INSPECTION OF A LOANER SET, IT WAS OBSERVED THAT THE RAD AIMING ARM/FRN GREATER TROCHANTER WAS BROKEN. THERE WAS NO KNOWN PATIENT OR HOSPITAL INVOLVEMENT. THIS REPORT IS FOR A RAD AIMING ARM/FRN GREATER TROCHANTER. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1082257 RAD AIMING ARM/FRN GREATER TROCHANTER ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES HSB WRIGHTS LANE SYNTHES USA PRODUCTS LLC 03.033.003 83P1180 10886982271075

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown