BEUDAMED
    FDA Adverse Event Other Summary report: N

    NONE

    MDR report key: 3241199 · Received November 28, 2006

    Report

    Report Number
    8010877-2006-00006
    Event Type
    Other
    Date Received
    November 28, 2006
    Manufacturer
    KOSCHER & WUERTZ GMBH
    Product Code
    GCJ
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INTEGRA LIFESCIENCES CORP. IS FILING ON BEHALF OF THE INITIAL DISTRIBUTOR (B)(4). CORRESPONDENCE SHOULD BE SENT TO: INTEGRA LIFESCIENCES CORPORATION, (B)(4), ATTN: CORPORATE COMPLAINT COORDINATOR. THE MANUFACTURER HAS BEEN NOTIFIED OF THE REPORTED COMPLAINT. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION. ACCORDING TO THE HOSPITAL, THE JAW BROKE DURING A SURGICAL PROCEDURE. THERE WAS NO PATIENT INJURY WHATSOEVER. AT THE DISTRIBUTOR'S REQUEST, THE INSTRUMENT WAS THOROUGHLY CHECKED BY (B)(4), WHO ARRIVED AT THE FOLLOWING CONCLUSION: RESULTS: THIS INSTRUMENT WAS MANUFACTURED IN SEPTEMBER 1999. THIS INSTRUMENT WAS MANUFACTURED WITH LOT NUMBER 362099. WITH OUR INVOICES NOS. (B)(4) OF (B)(4)1999. WE SHIPPED YOU A TOTAL OF (B)(4) PCS. A TOTAL OF (B)(4) HAS BEEN SOLD TO (B)(4) SINCE JUNE 1998, WHEN K AND W STARTED TO MANUFACTURE THIS PRODUCT. SO FAR WE HAVE DOCUMENTED NO COMPLAINT AND NO MDR OF THIS NATURE REGARDING THIS ARTICLE. THE PRODUCT DOCUMENTS OF THIS LOT PROVE THAT THE RIGHT MATERIALS/COMPONENTS WERE USED AND THAT THE INSTRUMENTS WERE MANUFACTURED IN ACCORDANCE WITH THE PRODUCTION SPECIFICATIONS. PERFORMING A VISUAL INSPECTION, WE DISCOVERED THAT THE JAW HINGE WAS BROKEN. UPON SUBJECTING A HARDNESS TEST, VALUES HRC (B)(4) WERE RECEIVED WHICH IS WITHIN THE TOLERANCE (44-48 HRC). PERFORMING A VISUAL INSPECTION UNDER THE MICROSCOPE WE DISCOVERED DEBRIS AND CORROSION IN THE HINGE AREA. BASED ON THE INFORMATION ESTABLISHED ABOVE, WE ARE UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE NON CONFORMANCE DESCRIBED. ONE POSSIBLE CAUSE OF BREAKAGE WHICH IS SEEN QUITE OFTEN IS AN INSUFFICIENT/ IMPROPER REPROCESSING AND/OR OVERSTRESSING OF THE INSTRUMENTS, RESULTING IN STRESS CRACKING CORROSION AND ULTIMATELY LEADING TO BREAKAGE. SINCE THIS EVALUATION INDICATES NO DEFECT OR MATERIAL, NO FAULTY DESIGN OR ANY DEFECT IN MANUFACTURING, WE FEEL THAT NO CORRECTIVE MEASURE IS TO BE TAKEN.

    Description of Event or Problem · 1

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NONE GCJ KOSCHER & WUERTZ GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1