BEUDAMED
    FDA Adverse Event Other Summary report: N

    *

    MDR report key: 1260069 · Received November 5, 2008

    Report

    Report Number
    9680515-2008-00009
    Event Type
    Other
    Date Received
    November 5, 2008
    Manufacturer
    TONTARRA MEDIZINTECHNIK GMBH
    Product Code
    LRW
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN REC'D FOR EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE INFO. INTEGRA LIFESCIENCES CORP IS FILING ON BEHALF OF THE INITIAL DIST. CORRESPONDENCE SHOULD BE SENT TO: INTEGRA LIFESCINECES CORP; ATTN: CORPORATE COMPLAINTS COORD. IT WAS REPORTED THAT THE INSTRUMENT HAD BEEN USED 133 TIMES. THERE WAS NO PT INJURY REPORTED. THE BROKEN HINGE PIECE WAS RETURNED FOR EVAL. CONCLUSION: BASED ON OUR FINDINGS AND OUR EXPERIENCE AS QUALIFIED MFR OF SURGICAL INSTRUMENTS, WE ARE OF THE OPINION THAT THE HINGE BREAK WAS CAUSED BY APPLYING TOO MUCH FORCE TO THE INSTRUMENT AND POSSIBLY THE JAW PARTS OF THE INSTRUMENT HAD BEEN SUBJECTED TO ANY KIND OF IMPACT. SINCE A REVIEW OF THE PRODUCTION DOCUMENTS DETERMINED THAT ALL APPLICABLE SPECS HAVE BEEN MET AND SINCE OUR TREND ANALYSIS REFLECTS NO PROBLEM WITH THIS DESIGN, NO CAPA ACTION IS REQUIRED. THE CUSTOMER SHOULD BE MADE AWARE THAT THE INSTRUMENT SHALL BE HANDLED WITH CARE AND THAT SHOULD NOT BE OVERSTRESSED. ANY KIND OF IMPACT TO THE RELATIVELY HARD SCISSORS BLADES MIGHT CAUSE CRACKS IN THE MATERIAL. PRIOR TO USE, A VISUAL TEST AS TO POSSIBLE CONTAMINATION AND/OR DEFECTS AS WELL AS FUNCTIONAL TEST SHOULD TAKE PLACE. INSTRUMENTS THAT ARE NOT IN PROPER CONDITION SHOULD IMMEDIATELY BE REMOVED FROM THE TRAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * * LRW TONTARRA MEDIZINTECHNIK GMBH * *

    Patients

    Seq Age Sex Outcome Treatment
    1