BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APPLICATION INSTRUMENT FOR STERNAL ZIPFIX

    MDR report key: 7558370 · Received May 31, 2018

    Report

    Report Number
    8030965-2018-54068
    Event Type
    Malfunction
    Date Received
    May 31, 2018
    Date of Event
    May 10, 2018
    Report Date
    May 11, 2018
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    JDQ
    UDI-DI
    07611819418424
    PMA / PMN Number
    K110789
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. D10: DATE DEVICE RETURNED TO MANUFACTURER. H3, H4, H6: A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED FOR PART: 03.501.080, LOT: 9790420: MANUFACTURING SITE: HÄGENDORF, RELEASE TO WAREHOUSE DATE: 31.MARCH.2016: THE DEVICE HISTORY RECORD SHOWS THIS LOT OF PIECES WAS PROCESSED THROUGH THE NORMAL MANUFACTURING AND INSPECTION OPERATIONS WITH NO REWORK OR NONCONFORMITIES NOTED. THIS LOT MET ALL DIMENSIONAL AND VISUAL CRITERIA AT THE TIME OF RELEASE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURING PROCESS. ONLY TOP LEVEL OF THE DEVICE HISTORY RECORD REVIEWED AS SUB-COMPONENTS ARE NOT LOT TRACKED. REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT WHICH WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. H3, H6: A PRODUCT INVESTIGATION WAS CONDUCTED. VISUAL INSPECTION: ON THE APPLIC-INSTR F/STERNAL ZIPFIX 03.501.080 IS ONE HALF, OF THE COMPONENT CUTTER 60030408, BROKEN OFF. CLOSE TO THE BROKEN OFF CUTTER THE HEAD OF THE INSTRUMENT IS DEFORMED. NO FURTHER DAMAGES ARE VISIBLE. DETAILS ARE SHOWN ON THE ATTACHED PRODUCT PHOTOS. FUNCTIONAL TEST: THE CUTTING OF THE ZIP FIX IMPLANTS IS NOT ANYMORE POSSIBLE ABOUT THE BROKEN CUTTER HEAD 60030408. THE FUNCTIONALITY OF THE APPLIC-INSTR F/STERNAL ZIPFIX 03.501.080 IS AFFECTED AS DESCRIBED IN THE COMPLAINT DESCRIPTION. DRAWING/SPECIFICATION REVIEW: THE MANUFACTURED AND CURRENT REVISIONS OF THE DRAWINGS WERE REVIEWED AND NO RELEVANT DESIGN CHANGES WERE IDENTIFIED. DIMENSIONAL INSPECTION: ACCORDING TO THE MEASURED DIAMETER OF THE CUTTER HEAD 60030408, NO DEVIATION OF THE MATERIAL CROSS SECTION NEAR THE BREAK WAS FOUND. A WEAKENING OF THE FRACTURE DUE TO INSUFFICIENT MATERIAL CROSS SECTION COULD NOT BE DETERMINED. MATERIAL OR HARDNESS REVIEW: THE HARDNESS OF COMPONENT CUTTER 60030408, AS DEFINED ON PRODUCT DRAWING HAS BEEN MEASURED. THE VALUE IS WITHIN SPECIFICATION. IN ACCORDANCE TO THIS TEST RESULT AND THE ASSEMBLED COMPONENTS, AS LISTED ON DHR, IT CAN BE DETERMINED THAT THE CORRECT RAW-MATERIAL HAS BEEN USED. SUMMARY: ACCORDING TO THE TEST RESULTS OF HARDNESS AND MATERIAL STRENGTH AT THE CROSS SECTION. NO REDUCED STRENGTH OF MATERIAL CAUSED THE BREAKAGE OF THE CUTTER. THEREFORE, MUST BE ASSUMED THAT MECHANICAL OVERLOAD HAS LED TO MALFUNCTION AND BREAKAGE OF THE CUTTER ON THE APPLIC-INSTR F/STERNAL ZIPFIX 03.501.080. THE HEAD OF THE INSTRUMENT IS DEFORMED. THIS COULD BE AN INDICATION THAT THE INSTRUMENT HAS FALLEN TO THE GROUND. THE IMPACT COULD HAVE LED DIRECTLY TO BREAKING OR WEAKENING THE COMPONENT CUTTER 60030408. NO MANUFACTURING RELATED ISSUE WAS IDENTIFIED AND/OR CONFIRMED. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. TO PREVENT SUCH PROBLEMS, IT IS NECESSARY WORN OR DAMAGED INSTRUMENTS TO REPLACE AND/OR TO OPERATE ACCORDING TO THE TECHNIQUE GUIDE, PAGE 13 ¿WARNING: DO NOT CUT THE IMPLANT UNTIL ALL IMPLANTS HAVE BEEN FULLY TENSIONED. IMPLANTS CANNOT BE TENSIONED ONCE CUT. DO NOT CUT IMPLANTS UNDER TENSION.". DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. A DEVICE HISTORY RECORDS REVIEW HAS BEEN REQUESTED. (B)(4). DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING A CORONARY ARTERY BYPASS GRAFTING (CABG) STERNAL CLOSURE ON (B)(6) 2018, THE STEEL PART NEAR THE NOSE OF THE CUTTING LEVER OF THE APPLICATOR CHIPPED OFF. FRAGMENTS WERE GENERATED FROM THE BREAKAGE AND WERE EASILY REMOVED. THE STERNUM WAS CLOSED USING STEEL WIRE INSTEAD OF ZIPFIX BANDS. SURGERY WAS DELAYED BY ABOUT TWENTY MINUTES. PATIENT STATUS IS UNKNOWN. THIS REPORT IS FOR AN APPLICATION INSTRUMENT FOR STERNAL ZIPFIX. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    401666 APPLICATION INSTRUMENT FOR STERNAL ZIPFIX CERCLAGE FIXATION JDQ OBERDORF SYNTHES PRODUKTIONS GMBH 9790420 07611819418424

    Patients

    Seq Age Sex Outcome Treatment
    1