BEUDAMED
    FDA Adverse Event Injury Summary report: N

    4.5MM CURVED BROAD LCP® PLATE 15 HOLES/282MM

    MDR report key: 7206827 · Received January 19, 2018

    Report

    Report Number
    2939274-2018-50323
    Event Type
    Injury
    Date Received
    January 19, 2018
    Report Date
    December 30, 2017
    Manufacturer
    WRIGHTS LANE : SYNTHES USA PRODUCTS LLC
    Product Code
    HRS
    UDI-DI
    10886982159243
    PMA / PMN Number
    K082807
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY REVIEW PART NO.: 226.652. LOT NO.: 9243436 MANUFACTURING LOCATION: (B)(4). RELEASE TO WAREHOUSE DATE: NOVEMBER 10, 2014 . NO NCRS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. A PRODUCT DEVELOPMENT INVESTIGATION WAS PERFORMED FOR THE SUBJECT DEVICE (LCP PLATE, PART NUMBER 226.652, LOT NUMBER 9243436). THE SUBJECT DEVICE WAS RETURNED WITH THE COMPLAINT CONDITION STATING THE DEVICE WAS FOUND TO BE BROKEN AT THE EIGHTH HOLE; SIGNIFICANT DEFORMATION AND CRACKING IS APPARENT AT THE SAME HOLE. THE COMPLAINT WAS CONFIRMED. THE COMPLAINT CONDITION WAS UNABLE TO BE REPLICATED DUE TO POST-MANUFACTURING DAMAGE. RELEVANT DRAWINGS FOR THE RETURNED DEVICE WERE REVIEWED (BOTH CURRENT REVISION AND FROM THE TIME OF MANUFACTURE). THE DESIGN, MATERIALS AND FINISHING PROCESSES WERE FOUND TO BE APPROPRIATE FOR THE INTENDED USE OF THIS DEVICE. NO DIMENSIONAL ANALYSIS IS POSSIBLE DUE TO POST-MANUFACTURING DAMAGE. THE ROOT CAUSE OF THE EVENT IS UNKNOWN A DEVICE HISTORY REVIEW, INCLUDING MATERIAL AND HARDNESS REVIEWS, WAS PERFORMED FOR THE RETURNED INSTRUMENT¿S LOT NUMBER AND NO MRRS OR COMPLAINT-RELATED ISSUES WERE IDENTIFIED WITH THE LOT NUMBER WHICH MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. 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 · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION SURGERY DUE TO A BROKEN 4.5MM CURVED BROAD LCP PLATE ON (B)(6) 2017. THE PLATE, SEVEN (7) LOCKING SCREWS, TWO (2) 1.7MM CABLES AND THREE (3) 4.5MM THREADED POSITIONING PINS, WERE ORIGINALLY IMPLANTED ON (B)(6) 2017 DURING A PERIPROSTHETIC MIDSHAFT FEMUR FRACTURE PROCEDURE WITH KNEE STEM. DURING THE REVISION THE BROKEN PLATE, AND INTACT SCREWS, CABLES AND PINS WERE ALL REMOVED SUCCESSFULLY AND THE PATIENT WAS REVISED TO A NEW SET OF IMPLANTS. NO SURGICAL DELAY WAS REPORTED AND PATIENT WAS LISTED AS STABLE AFTER THE SURGERY. CONCOMITANT DEVICES REPORTED: PART # 212.202, LOT # UNKNOWN, QUANTITY # 1, PART # 212.212, LOT # UNKNOWN, QUANTITY # 1 , PART # 212.213, LOT # UNKNOWN, QUANTITY # 1 , PART # 212.214, LOT # UNKNOWN, QUANTITY # 3 , PART # 212.218, LOT # UNKNOWN , QUANTITY # 1 , PART # 298.801.01S, LOT # P269025, QUANTITY # 1 , PART # 298.801.01S, LOT # P276185, QUANTITY# 1 , PART # UNK - PINS/WIRES, LOT # UNKNOWN, QTY # 3. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    50218 4.5MM CURVED BROAD LCP® PLATE 15 HOLES/282MM PLATE, FIXATION, BONE HRS WRIGHTS LANE : SYNTHES USA PRODUCTS LLC 226.652 9243436 10886982159243

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention