BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BROCUFF BIONX IMPLANT

    MDR report key: 500146 · Received December 9, 2003

    Report

    Report Number
    500146
    Event Type
    Malfunction
    Date Received
    December 9, 2003
    Date of Event
    August 28, 2003
    Report Date
    September 2, 2003
    Manufacturer
    BIONX IMPLANTS INC
    Product Code
    HWC
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    DURING (L) KNEE ARTHROSCOPY BIONX SCREW BROKE UPON INSERTION - SCREW REMOVED AND ANOTHER SCREW INSERTED.

    Description of Event or Problem · 1

    ADD'L INFO REC'D FROM MFR 1/20/04: THIS IS NOT CONSIDERED A REPORTABLE EVENT AND AN MDR HAS NOT BEEN FILED. LINVATEC BIOMATERIALS DOES NOT FEEL THIS IS A REPORTABLE EVENT FOR THE FOLLOWING REASONS: A. THERE WAS NO ADVERSE EVENT REPORTED BY THE REPORTER. THE REPORTER INDICATED THE BIOCUFF BROKE DURING INSERTION, WAS REMOVED, AND THE ANOTHER WAS USED SUCCESSFULLY. B. THE REPORTER INDICATED THE BIOCUFF IMPLANT WAS USED IN A KNEE SURGERY. THE BIOCUFF IS INDICATED FOR USE IN FACILITATING AND MAINTAINING SECURE FIXATION BETWEEN SOFT TISSUE AND BONE AT THE TORN ROTATOR CUFF TENDON AND HUMERAL HEAD OF THE SHOULDER. THIS IS CLEARLY REFERENCED IN THE PRODUCT INSERT WITH EVERY PRODUCT DISTRIBUTED. C. THE REPORT OF A BIOCUFF BREAKING DURING INSERTION IN ROTATOR CUFF TEAR SURGERY IS A KNOWN FAILURE MODE. THIS IS CAUSED BY THE USER APPLYING OVER TORQUE WHEN INSERTING AND/OR NOT USING A DRILL AND TAP TO PREPARE A PROPER GUIDE HOLE IN THE BONE. D. A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS SPECIFIC LOT SHOWS THERE WERE NO ANOMALIES ASSOCIATED WITH THIS LOT DURING ACTUAL PRODUCTION. AT THIS TIME, LINVATEC BIOMATERIALS CONSIDERS THIS REPORT AS NOT REPORTABLE AND CONSIDERS THE EVENT CLOSED. LINVATEC HAS DOCUMENTED FOUR (4) TIMES ITS ATTEMPTS TO OBTAIN ADD'L INFO FROM THE HOSP AND THE PRODUCT FOR FURTHER INVESTIGATION. TO DATE, THE HOSP HAS NOT RETURNED THE PRODUCT. IF THE HOSP RETURNS THE ACTUAL PRODUCT, A FORMAL INVESTIGATION WILL BE PERFORMED AND DOCUMENTED. THE REPORT FROM THE HOSPITAL IS UNDER OUR RGA #721435. BASED UPON THE INFO OBTAINED BIOMATERIALS DOES NOT CONSIDER THIS A MALFUNCTION OF THE PRODUCT, BUT RATHER USER ERROR. LINVATEC IS SENDING A LETTER TO THE CUSTOMER ADVISING THEM OF THE PROPER INTENDED USE OF THE BIOCUFF IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BROCUFF BIONX IMPLANT SCREW IMPLANT HWC BIONX IMPLANTS INC 5.7 X 28MM 850368

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Other