BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHARNLEY INIT INCIS RETR

    MDR report key: 2795660 · Received October 18, 2012

    Report

    Report Number
    1818910-2012-22728
    Event Type
    Malfunction
    Date Received
    October 18, 2012
    Date of Event
    October 1, 2012
    Report Date
    October 15, 2012
    Manufacturer
    DEPUY RAYNHAM
    Product Code
    LXH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    INVESTIGATION RESULTS: THE COMPLAINT WAS RECEIVED INTO THE LEEDS QUALITY DEPARTMENT (B)(4) 2012. FOLLOWING RECEIPT OF PRODUCT, THE COMPLAINT WAS TRANSFERRED TO INVESTIGATION (B)(4) 2012. INSPECTION CONFIRMED THAT ONE OF THE OUTSIDE TEETH WAS BROKEN OFF THE FIXED RETRACTOR ARM. FURTHER INSPECTION IDENTIFIED CONSIDERABLE HAMMER DAMAGE DOWN BOTH SIDES OF THE FIXED RETRACTOR ARM, INCLUDING HAMMER DAMAGE ON THE BROKEN TOOTH. THIS WAS CONSISTENT WITH EXTENSIVE USE/MISUSE. A REVIEW OF MANUFACTURING RECORDS WAS COMPLETED BY DEPUY QUALITY DEPARTMENT, WITH NOTIFICATION RECEIVED THAT: A REVIEW OF THE DHR (DEVICE HISTORY RECORD) FOR PRODUCT NUMBER 962256000 LOT NUMBER 1122862 FOUND NO ANOMALIES. (B)(4). ETQ COMPLAINTS DATABASE SEARCHED ON PRODUCT LOT 1122862 IDENTIFIED NO PREVIOUS COMPLAINTS. ETQ COMPLAINTS DATABASE SEARCHED ON PRODUCT CODE 962256000 IDENTIFIED NO OTHER COMPLAINTS RAISED OVER THE LAST 3 YEARS.

    Description of Event or Problem · 1

    ONE OF THE TEETH FROM THE CHARNLEY RETRACTOR BLADE WAS RETAINED IN THE PATIENT'S FASCIA LAYER. UNFORTUNATELY THIS WAS NOT NOTED AT THEATRE LEVEL, SO THE PATIENT HAD TO BE RETURNED TO SURGERY. PATIENT WAS BROUGHT BACK TO THEATRE ON THE SAME DAY TO REMOVE THE METAL PIECE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CHARNLEY INIT INCIS RETR DEPUY INSTRUMENT LXH DEPUY RAYNHAM 1122862

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention