BEUDAMED
    FDA Adverse Event Other Summary report: N

    JARIT BONE HOOK

    MDR report key: 2288039 · Received May 16, 2007

    Report

    Report Number
    9611461-2007-00001
    Event Type
    Other
    Date Received
    May 16, 2007
    Report Date
    April 4, 2007
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MFR WILL BE INFORMED OF THIS INCIDENT. INTEGRA LIFESCIENCES CORP IS FILING ON BEHALF OF THE INITIAL DISTRIBUTOR (B)(4). ADDITIONAL INFO FROM THE USER FACILITY REPORT: (B)(4). DATE RECEIVED BY MFR: 03/28/2007. AS REQUESTED, THE INSTRUMENT WAS THOROUGHLY CHECKED BY (B)(4) WITH LOT # 9/06, 101 INSTRUMENTS HAVE BEEN MANUFACTURED IN SEPTEMBER 2006, AND DELIVERED TO THE DISTRIBUTOR ON 09/07/2006 WITH INVOICE NO (B)(4). SINCE JULY 2003, WHEN WE STARTED DELIVERY OF THIS ARTICLE, WE HAVE SHIPPED A TOTAL QUANTITY OF (B)(4) PIECES OF THIS ARTICLE TO THE DISTRIBUTOR. WE HAVE RECEIVED TWO OTHER COMPLAINTS, ONE IN 2006 THAT RELATES TO SIMILAR ARTICLE OF THE SAME PRODUCT FAMILY (ARTICLE 240-196) AND ONE IN 2007 THAT RELATES TO SAME ARTICLE. ON BOTH INSTRUMENTS, THE TIPS HAD BEEN BROKEN OFF AND AS POSSIBLE CAUSE OVERSTRESSING OR MISUSE WAS ASSUMED. FOR FURTHER INFO, PLEASE REFER TO THE DISTRIBUTOR'S COMPLAINT NO (B)(4) OR THE MFR MEDWATCH REPORT NO 9611461-2006-00003, THAT HAD BEEN SUBMITTED IN RELATION TO IT. RESPECTIVELY TO THE DISTRIBUTOR'S COMPLAINT NO (B)(4). THE PRODUCTION DOCUMENTS OF THIS LOT PROVE THAT THE RIGHT MATERIALS / COMPONENTS WERE USED AND THAT THE INSTRUMENT WAS MANUFACTURED IN ACCORDANCE WITH THE PRODUCTION SPECIFICATIONS. AS PER THE HARDENING PROTOCOL OF (B)(4), WHICH IS PART OF THE PRODUCTION DOCUMENTS, THE HARDNESS OF THE INSTRUMENT IS (B)(4), WHICH IS STILL WITHIN THE GIVEN RANGE OF TOLERANCE (B)(4). CONCLUSION: BASED ON OUR LONGTERM EXPERIENCE AS QUALIFIED INSTRUMENT MFRS, WE ASSUME THAT THE INSTRUMENT WAS STRESSED IN EXCESS OF ITS DESIGN AND, THUS, ITS INTENDED USE, WHAT FINALLY COULD HAVE CAUSED THE BREAK. ALREADY AFTER THE LAST COMPLAINT WE INTRODUCED A DESIGN IMPROVEMENT AS A MATTER OF PRECAUTION. THE DESIGN OF THIS PRODUCT FAMILY (240-195, -196 + 197) WILL BE SLIGHTLY CHANGED, (B)(4). ALL FUTURE DELIVERIES WILL BE EFFECTED IN THE NEW DESIGN.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT THE TIP OF THE BONE HOOK BROKE OFF DURING SURGERY FOR TOTAL HIP ARTHROPLASTY. AN X-RAY WAS TAKEN AND THE BROKEN TIP WAS NOT LOCATED. NO PT INJURY IS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JARIT BONE HOOK BONE HOOK LXH

    Patients

    Seq Age Sex Outcome Treatment
    1