BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V. MUELLER SPURLING RONGEUR

    MDR report key: 2137838 · Received October 12, 2007

    Report

    Report Number
    8010386-2007-00001
    Event Type
    Malfunction
    Date Received
    October 12, 2007
    Manufacturer
    S.U.A. MARTIN & GMBH & CO. KG
    Product Code
    DWS
    PMA / PMN Number
    PREAMEND
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBMISSION OF THIS MEDWATCH HAS BEEN DELAYED DUE TO THE FACT THAT AT OUR REQUEST, THE INSTRUMENT WAS ONLY RETURNED TO US ON (B)(6) 2007. FURTHER DELAY WAS CAUSED BY THE NECESSITY OF HAVING TO CONTACT AND REACHING THE PROPER PARTY AT THE HOSP FOR FURTHER INFO ON THE EVENT. THIS LED TO (B)(6) MEDICAL CTR CHANGING THEIR MDR REPORTING PROCEDURES. THE FACILITY HAD NOT BEEN AWARE THAT SUCH A REPORT MUCH BE FILED WHEN SURGICAL INTERVENTION WAS REQUIRED TO PREVENT PT INJURY. THE UF MEDWATCH HAS JUST BEEN FORWARDED TO US. THE INITIAL REPORTER OF THIS EVENT WAS THE USER FACILITY PROCESS MGR. RESULTS: THE MFR OF THE INSTRUMENT IN QUESTION WAS COMPLETED IN A LOT OF 30 PCS ON (B)(6) 2001 AND DELIVERED TO THE INITIAL IMPORTER AND PRIVATE LABEL DISTRIBUTOR WITH INVOICE NO. (B)(4) ON (B)(6) 2001. APPROX 2000 PCS OF THIS MODEL HAVE BEEN DELIVERED TO DATE. THIS IS THE FIRST FRACTURE THAT HAS BEEN REPORTED TO US. A THOROUGH REVIEW OF OUR PRODUCTION RECORDS CONFIRMS THAT THE DEVICE WAS PRODUCED OF THE SPECIFIED (B)(4) AND CONFIRMED IN ALL OTHER RESPECTS TO THE MFG AND THE PRIVATE LABEL DISTRIBUTOR'S DESIGN VARIATION SPECIFICATIONS. IT ALSO MET THE QUALITY MGMT IN-PROCESS TESTS AND VERIFICATIONS AND PASSED THE 100% FUNCTION AND QUALITY TESTING, PERFORMED BY OUR SENIOR MEDICAL DEVICE ENGINEERS PRIOR TO SHIPPING. AS PART OF THE INVESTIGATION, A HARDENING TEST WAS PERFORMED ON THE UPPER PART OF THE BROKEN JAW, RESULTING IN 47.0 HRC, FALLING WITHIN THE SPECIFIED TOLERANCE RANGE OF 43-48 HRC. THE INSTRUMENT WAS THOROUGHLY INSPECTED VISUALLY AND UNDER THE MICROSCOPE. SINCE THE BROKEN-OFF JAW PART WAS NOT RETURNED, IT IS DIFFICULT TO DETERMINE THE EXACT CAUSE FOR THIS FRACTURE. HOWEVER, THE INSTRUMENT EXHIBITS EVIDENCE OF INTENSIVE USE. THE CUTTING PORTION OF THE UPPER SLIDING PART SHOWS RESULTS OF HEAVY WEAR-AND-TEAR AND MARKS THAT COULD INDICATE THAT IT MIGHT HAVE BEEN USED FOR CUTTING OR HOLDING VERY HARD MATERIALS OR OTHER INSTRUMENTS, WHEREAS THE INSTRUMENT IS DESIGNED TO CUT ONLY BONE AND TISSUE. THE CONDITION OF THE INSTRUMENT ALSO SUGGESTS THAT IT WAS NOT PROPERLY FUNCTION-TESTED PRIOR TO REUSE. IT SHOULD HAVE BEEN RESHARPENED SEVERAL PROCEDURES PRIOR TO THE EVENT OCCURRING. THE DULLNESS MAY HAVE POSSIBLY LED TO THE SURGEON USING EXTRA FORCE WHICH RESULTED IN THE FRACTURE, ESPECIALLY SINCE THE DEVICE APPEARS AS IF HAS BEEN REWORKED SEVERAL TIMES. THIS LEADS TO THINNING OF THE CUTTING JAWS THAT COULD, AFTER SO MANY YRS OF USE, RESULT IN THE DEVICE NO LONGER BEING SAFE FOR THE INTENDED INDICATIONS. CONCLUSION: NO DEFINITE CONCLUSION FOR THE EXACT CAUSE OF THIS BREAK CAN BE DRAWN. BASED ON OUR LONG-TERM EXPERIENCE AS QUALIFIED SURGICAL INSTRUMENT MFR, WE ASSUME THAT OVERSTRESSING AND OVER-USING THE INSTRUMENT AFTER REPEATED REWORKINGS THAT RESULTED IN THE CUTTING EDGES NOT CONFORMING TO ORIGINAL SPECIFICATIONS, MIGHT HAVE RESULTED IN THE BREAKAGE. OUR PRODUCTION RECORDS INDICATE COMPLIANCE WITH ALL SPECIFICATIONS AND OUR TREND ANALYSIS REFLECTS NO PROBLEM WITH THIS PATTERN TO DATE. THEREFORE, NO CORRECTIVE OR PREVENTIVE ACTION IS REQUIRED ON OUR PART. HOWEVER, TO PREVENT FUTURE EVENTS, THE USER SHOULD BE INSTRUCTED TO FUNCTION-TEST DEVICES DURING REPROCESSING, INCLUDING AFTER RESHARPING AND/OR REWORKING THE DEVICE TO MAKE SURE IT MEETS THE REQUIREMENTS FOR THE INTENDED INDICATIONS.

    Description of Event or Problem · 1

    .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 V. MUELLER SPURLING RONGEUR MANUAL RONGEUR DWS S.U.A. MARTIN & GMBH & CO. KG MD43

    Patients

    Seq Age Sex Outcome Treatment
    1