BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TARGET DEVICE 300 X 160 MM

    MDR report key: 2208685 · Received August 8, 2011

    Report

    Report Number
    9610622-2011-00348
    Event Type
    Malfunction
    Date Received
    August 8, 2011
    Date of Event
    July 18, 2011
    Report Date
    July 19, 2011
    Manufacturer
    STRYKER OSTEOSYNTHESIS KIEL
    Product Code
    LXH
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: NO MFG FAULTS FOUND. THE SUBJECT OF THE COMPLAINT, PROBLEMS WITH DISTAL LOCKING COULD NOT BE VERIFIED. THE DEVICES WERE DOCUMENTED AS FAULTLESS PRIOR TO DISTRIBUTION AND HAD BEEN IN USE FOR A LONGER TIME (SINCE 2006/2008). THUS WE PRE-SUPPOSE THAT THE DEVICES HAD FULFILLED THEIR TASKS IN FORMER SURGERIES AS INTENDED, WITHOUT ANY PROBLEMS REPORTED. EVAL REVEALED EVIDENCE THAT THE REPORTED EVENT IS NOT KINKED TO A DEFICIENCY OF THE DEVICE, BUT RATHER RELATED TO AN INTRA-OPERATIVE PROCEDURE. LOT KME 902045 MFG DATE: 06/2008.

    Description of Event or Problem · 1

    THE NURSE, REPORTED TO OUR SALES REP, THAT DURING USING THE TWO TARGET DEVICES THE DISTAL DRILLINGS ARE WRONG. THE MEDULLARY CAVITA OPENINGS ARE BIXCUT. GAMMA3 NAILS WERE USED. REPLACEMENTS WERE AVAILABLE SO THAT THE SURGEON COULD COMPLETED THE SURGERIES WITHOUT PROLONGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TARGET DEVICE 300 X 160 MM INSTRUMENT LXH STRYKER OSTEOSYNTHESIS KIEL NA KME901095 KME9020

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other