BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CROSS FT PUNCH, 4.5MM

    MDR report key: 2202507 · Received August 11, 2011

    Report

    Report Number
    1017294-2011-00025
    Event Type
    Malfunction
    Date Received
    August 11, 2011
    Date of Event
    June 29, 2011
    Report Date
    August 11, 2011
    Manufacturer
    CONMED LINVATEC
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONMED LINVATEC RECEIVED 4 CROSS FT PUNCH FOR EVALUATION AND CONFIRMED THE REPORTED PROBLEM. VISUAL EXAMINATION OF THE RETURNED DEVICES FOUND ALL 4 WERE CLEARLY MARKED AS PER PFT-00M (4.5/5.5/6.5MM). A REVIEW OF THE DEVICE HISTORY RECORD FOR LOT #156920 SHOWS THAT ALL 10 UNITS OF THIS LOT EXHIBIT THIS NONCONFORMANCE. IT WAS DETERMINED THAT THE WRONG PROGRAM NUMBER ((B)(4)) WAS ENTERED DURING THE MANUFACTURING PROCESS. IN THIS INSTANCE, THE VERIFICATION/INSPECTION STEPS DID NOT DETECT THE OPERATOR ERROR. BASED ON THE INVESTIGATION, THIS ISSUE IS ISOLATED TO CATALOG #PFT-45M, LOT #156920. A REVIEW OF THE COMPLAINT HISTORY SHOWS NO SIMILAR REPORTS RECEIVED FOR THIS PRODUCT. THE INVESTIGATION DETERMINED THAT THIS NONCONFORMANCE IS A PROCESS ERROR. A CORRECTIVE ACTION AND PREVENTATIVE ACTION HAS BEEN INITIATED TO IDENTIFY AND IMPLEMENT THE NECESSARY ACTIONS TO PREVENT FUTURE RECURRENCES. AS A RESULT, ALL INVOLVED MANUFACTURING OPERATORS WERE RE-TRAINED ON (B)(4) 2011 TO DOUBLE CHECK JOB ITEM# AND ETCH DRAWING PACKAGE FOR ACCURACY. IN ADDITION, ALL APPLICABLE DRAWINGS WILL BE UPDATED TO INCLUDE ETCH DRAWING NUMBER ON THE PROCESS TRAVELERS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING SURGERY, IT WAS NOTICED THAT THE PUNCH DEPTH MARKINGS OF THE PFT-45M (CROSS FT PUNCH, 4.5MM) WERE MARKED AS PFT-00M (ALL IN ONE CROSS FT PUNCH 4.5/5.5/6.5MM) INSTEAD OF JUST 4.5MM. THE PROCEDURE WAS COMPLETED BY USING THIS PUNCH AS IF IT WAS A PFT-00M, BUT THAT IT WAS ONLY BEING USED BY INSERTING THE PUNCH TO THE 4.5MM DEPTH MARKING. THERE WAS NO PATIENT INJURY AND NO SURGICAL DELAY WITH THIS REPORTED PROBLEM. FURTHER INSPECTION OF 3 MORE UNITS OF PFT-45M (LOT #156920) BY THE INTERNATIONAL AFFILIATE FOUND THAT ALL 3 UNITS WERE AFFECTED. PACKAGING AND LABELING OF ALL 4 UNITS WERE LABELED AS PFT-45M AND WAS NOT LABELED AS PFT-00M.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CROSS FT PUNCH, 4.5MM ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH CONMED LINVATEC 156920

    Patients

    Seq Age Sex Outcome Treatment
    1