BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LONG ROUND DIAMOND BUR

    MDR report key: 2223377 · Received August 25, 2011

    Report

    Report Number
    1017294-2011-00033
    Event Type
    Malfunction
    Date Received
    August 25, 2011
    Report Date
    August 25, 2011
    Manufacturer
    CONMED LINVATEC
    Product Code
    HWE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING PROCESS REVEALED THAT NEITHER THE PACKAGING SYSTEM NOR THE MATERIAL HANDLING CONTRIBUTED TO THIS DEFECT. PREVIOUS INVESTIGATION OF SIMILAR COMPLAINT DID INDICATE THAT HAND PULLING THE TYVEK LID CAN CREATE A POTENTIAL INTEGRITY ISSUE. THE DOCUMENT FURTHER INDICATED THAT REWORKING THE LABEL SEEMED TO BE THE MOST LIKELY OPPORTUNITY FOR THIS TYPE OF DEFECT (PARTIAL OR OPEN SEAL) TO OCCUR. ONCE THE BLISTER IS SEALED AND INSPECTED A LABEL IS PLACED. AT THIS POINT THE SEALED PACKAGE IS WARM AND THE ADHESIVE IS STILL CURING. THIS MAKES THE PACKAGE MORE SUSCEPTIBLE TO SEAL ISSUES IF STRESSES ARE APPLIED TO THE SEALING SURFACE AREA WHILE REMOVING THE LABEL AND REAPPLYING A NEW ONE DURING REWORKING LABEL PROCESS. AS A RESULT OF THIS FINDING, THE MANUFACTURING PROCESS SEQUENCE HAS SINCE BEEN CHANGED AND ASSOCIATED DOCUMENTS AND PROCEDURES TO HAVE THE LABEL PROCESS PRIOR TO VISUAL INSPECTION. ONCE THE LABEL IS CORRECTLY APPLIED AND IS FOUND ACCEPTABLE, THEN VISUAL INSPECTION WILL BE PERFORMED.

    Additional Manufacturer Narrative · 1

    EVALUATION FINDINGS: CONMED LINVATEC RECEIVED AN UNOPENED PACKAGE CONTAINING THE L20D LONG ROUND DIAMOND BUR FOR EVALUATION AND CONFIRMED THE REPORTED PROBLEM. VISUAL EXAMINATION OF THE PACKAGE FOUND THE UPPER LEFT CORNER OF THE PACKAGE WAS PARTIALLY PEELED (NOT SEALED). (B)(4). AN INVESTIGATION IS IN PROGRESS TO DETERMINE THE ROOT CAUSE OF THIS REPORTED PROBLEM AND A FOLLOW-UP WILL BE FILED ONCE THE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    OUR DISTRIBUTOR IN (B)(4) REPORTED THAT DURING RECEIVING AND INSPECTION OF INCOMING PRODUCTS, IT WAS NOTED THAT THE STERILE PACKAGE CONTAINING THE L20D LONG ROUND DIAMOND BUR WAS NOT PROPERLY SEALED AND THE PRODUCT STERILITY WAS THEREFORE COMPROMISED. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LONG ROUND DIAMOND BUR INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT HWE CONMED LINVATEC 270918

    Patients

    Seq Age Sex Outcome Treatment
    1