BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GLENOSPHERE ORIENTATION GUIDE

    MDR report key: 5363224 · Received January 13, 2016

    Report

    Report Number
    1818910-2016-10649
    Event Type
    Malfunction
    Date Received
    January 13, 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

    (B)(4). 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 REF. 230795000 / LOT 5024128 AND (B)(4) OTHER SIMILAR COMPLAINT FOR THE COMBINAISON REF. 230774002 / LOT 5120205. THE ROD FOR REAMING GUIDE HOLDER (LOT N°5120205) RELATED TO THIS COMPLAINT WAS MANUFACTURED AFTER THE DESIGN CHANGED INITIATED BY (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) 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

    ADDITIONAL NARRATIVE: 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). FOLLOWUP WITH THE COMPLAINANT HAS BEEN CONDUCTED FOR THE LOT NUMBER, AND THE INFORMATION IS NOT AVAILABLE.

    Description of Event or Problem · 1

    ORIENTATION GUIDE IS CRACKED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    21899 GLENOSPHERE ORIENTATION GUIDE SHOULDER INSTRUMENT/TRIAL LXH DEPUY FRANCE S.A.S.-SAINT PRIEST ¿ REG# 3003895575 5024128

    Patients

    Seq Age Sex Outcome Treatment
    1