BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROD FOR REAMING GUIDE HOLDER

    MDR report key: 5370468 · Received January 15, 2016

    Report

    Report Number
    1818910-2016-11031
    Event Type
    Malfunction
    Date Received
    January 15, 2016
    Date of Event
    December 19, 2015
    Report Date
    January 5, 2016
    Manufacturer
    DEPUY FRANCE S.A.S.-SAINT PRIEST ¿ REG# 3003895575
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DESCRIPTION STATES THAT ROD TIP IS BENT AND THE ORIENTATION GUIDE IS CRACKED. THE DEVICES ASSOCIATED TO THE COMPLAINT WERE NOT RETURNED FOR ANALYSIS. THE DHR ANALYSIS PERFORMED DID NOT REVEAL ANY ANOMALIES THAT COULD BE RELATED TO THE ISSUE REPORTED ON THE COMPLAINT. A SEARCH INTO THE COMPLAINTS DATABASE WAS PERFORMED, NO OTHER SIMILAR COMPLAINT WAS REPORTED FOR THE AFFECTED PRODUCT CODE AND LOT COMBINATION (B)(4) / LOT 5024128 AND (B)(4)OTHER SIMILAR COMPLAINT FOR THE COMBINATION (B)(4) / LOT 5120205. THE ROD FOR REAMING GUIDE HOLDER (LOT N°5120205) RELATED TO THIS COMPLAINT WAS MANUFACTURED AFTER THE DESIGN CHANGED INITIATED BY CAPA-(B)(4) (NEW DEFINITION STARTING FROM BATCH 5120205). THE ORIENTATION GUIDE (LOT N°230795000) RELATED TO THIS COMPLAINT WAS MANUFACTURED AFTER THE DESIGN CHANGE INITIATED VIA (B)(4) IN MAY 2008. (THIS BATCH WAS MANUFACTURED IN JANUARY 2010. BASED ON THE INFORMATION RECEIVED AND THE INVESTIGATION PERFORMED, THE ROOT CAUSE OF THE INCIDENT COULD NOT BE DETERMINED. DEPUY STILL CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THE INVESTIGATION ONCE IT HAS BEEN COMPLETED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. (B)(4).

    Description of Event or Problem · 1

    ROD TIP IS BENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    29926 ROD FOR REAMING GUIDE HOLDER SHOULDER INSTRUMENT/TRIAL LXH DEPUY FRANCE S.A.S.-SAINT PRIEST ¿ REG# 3003895575 5120205

    Patients

    Seq Age Sex Outcome Treatment
    1