BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRIVE SHAFT-MINIMUM 520MM LENGTH-FOR USE WITH RIA

    MDR report key: 3377781 · Received October 1, 2013

    Report

    Report Number
    1719045-2013-01988
    Event Type
    Malfunction
    Date Received
    October 1, 2013
    Report Date
    September 3, 2013
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HTO
    PMA / PMN Number
    K013527
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED AND/OR EXPLANTED. DATES OF MANUFACTURE: 6/25/2008, 6/23/2009, AND 5/06/2011. A REVIEW OF SYNTHES DEVICE HISTORY RECORDS FOR LOT 15804-01 REVEALED THE DRIVE SHAFT ¿ MINIMUM 520MM LENGTH ¿ FOR USE WITH RIA WAS MANUFACTURED BY CRITERION TOOL & DIE. ORIGINALLY LOT 5815891 WAS REVIVED ON PO 891657, DATED 6/23/08 FOR 20 PARTS, WAS INSPECTED TO THE SYNTHES INCOMING FINAL INSPECTION SHEET NUMBER 314IF741 REVISION J ON 6/25/08. THE PARTS CONFORMED TO ALL REQUIREMENTS. THE CERTIFICATE OF COMPLIANCE WAS DATED 6/19/08. 20 PARTS WERE RELEASED TO THE WAREHOUSE ON 6/25/08. THE 20 PARTS WERE REWORKED TO BE REPACKAGED ON WO (B)(4) AND GIVEN THE LOT NUMBER 6170569 AND RELEASED TO THE WAREHOUSE ON 6/23/09. ON 4/29/11 PO 1265015 WAS RECEIVED FOR 18 REWORKED PARTS. THE REWORK WAS UNDER DCO (B)(4) TO ETCH A CE MARK AND UPDATE DRAWING FORMATS, THE LOT NUMBER CHANGED TO 15804-01. 18 PARTS WERE INSPECTED TO 314FI741 REVISION A ON 5/5/11. THE PARTS CONFORMED TO ALL REQUIREMENTS. THE CERTIFICATE OF COMPLIANCE WAS DATED 6/19/08. EIGHTEEN PARTS WERE RELEASED TO THE WAREHOUSE ON 5/6/11. 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. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. PLACEHOLDER.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE SALES CONSULTANT: THE DRIVE SHAFT WAS FOUND BROKEN UPON OPENING THE SET TO CHECK THE CONTENTS. CONSULTANT CHECKED WITH THE FACILITY: FACILITY STATED THEY HAVE NO RECORD OF THE DRIVE SHAFT BREAKING DURING A PROCEDURE OR OTHERWISE AND THE FACILITY RESPONDED THAT THEY HAVE NO RECORD REGARDING AN EVENT ASSOCIATED WITH THE COMPLAINT DEVICE. THIS IS 1 OF 1 REPORT FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    496094 DRIVE SHAFT-MINIMUM 520MM LENGTH-FOR USE WITH RIA HTO SYNTHES MONUMENT 15804-01

    Patients

    Seq Age Sex Outcome Treatment
    1