BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GLEN RESURFACING REAMER D27 MM

    MDR report key: 3537993 · Received December 26, 2013

    Report

    Report Number
    1818910-2013-36953
    Event Type
    Malfunction
    Date Received
    December 26, 2013
    Date of Event
    December 19, 2013
    Report Date
    December 19, 2013
    Manufacturer
    DEPUY FRANCE SAS REG. # 3003895575
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS STILL IN INVESTIGATION.

    Additional Manufacturer Narrative · 1

    DHR ANALYSIS: THE DHR ANALYSIS OF THE BATCH RETURNED SHOWS AN INITIAL CONFORMANCE OF THIS PRODUCT WITH REGARDS TO ITS SPECIFICATION. FOR THIS BATCH, IT THERE DID NOT HAVE DEVIATION OR FAILURE INVESTIGATION REPORT. THIS BATCH (5021712) WAS MANUFACTURED IN JANUARY 2010 BEFORE THE IMPROVEMENT REQUESTED FROM MANUFACTURER (FNC 2010-188 FOR THE BATCHES SINCE OCTOBER 2010). PRODUCT ANALYSIS: THE PRODUCT WAS CHECKED ( HARDNESS), IT IS IN CONFORMITY. THE VISUAL ANALYSIS SHOWS WORN EDGES. THIS PRODUCT BEEN CHECKED DIMENSIONALLY AT VARIOUS PLACES (PLAN DWG-7E070157REV B). THE PRODUCT IS AN OLD MANUFACTURING ACHIEVED BEFORE THE SUPPLIER ACTION (FNC 2010-188). THE ROOT CAUSE IS RELATED TO WEAR. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ANY ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    Description of Event or Problem · 1

    THE INSTRUMENT DOES NOT CUT PROPERLY

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    675373 GLEN RESURFACING REAMER D27 MM SHOULDER INSTRUMENT LXH DEPUY FRANCE SAS REG. # 3003895575 5021712

    Patients

    Seq Age Sex Outcome Treatment
    1