BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APPLICATION INSTRUMENT FOR STERNAL ZIPFIX

    MDR report key: 7707491 · Received July 20, 2018

    Report

    Report Number
    8030965-2018-55193
    Event Type
    Injury
    Date Received
    July 20, 2018
    Date of Event
    July 3, 2018
    Report Date
    July 3, 2018
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    JDQ
    UDI-DI
    10887587010847
    PMA / PMN Number
    K110789
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    NURSE

    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. PART: 03.501.080; LOT: 9790420; MANUFACTURING SITE: HAEGENDORF; RELEASE TO WAREHOUSE DATE: MARCH 30, 2016 THE DEVICE HISTORY RECORD SHOWS THIS LOT WAS PROCESSED THROUGH THE NORMAL MANUFACTURING AND INSPECTION OPERATIONS WITH NO REWORK OR NONCONFORMITIES NOTED. THIS LOT MET ALL DIMENSIONAL, VISUAL AND FUNCTIONAL 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. INVESTIGATION SELECTION INVESTIGATION SITE: HÄGENDORF; SELECTED FLOW(S): 5. BROKEN 2.1 VISUAL INSPECTION: ON THE APPLIC-INSTR F/STERNAL ZIPFIX 03.501.080 ONE HALF OF THE COMPONENT CUTTER 60030408, IS BROKEN OFF. CLOSE TO THE BROKEN OFF CUTTER, THE HEAD OF THE INSTRUMENT IS DEFORMED. NO FURTHER DAMAGES ARE VISIBLE. 2.2 FUNCTIONAL TEST: THE CUTTING OF THE ZIP FIX IMPLANTS IS NOT POSSIBLE ANYMORE 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. 2.3 DRAWING/SPECIFICATION REVIEW: THE MANUFACTURED AND CURRENT REVISIONS OF THE DRAWINGS WERE REVIEWED AND NO RELEVANT DESIGN CHANGES WERE IDENTIFIED. 2.4 DIMENSIONAL INSPECTION: ACCORDING TO THE MEASURED DIAMETER OF THE CUTTER HEAD 60030408, NO DEVIATION OF THE MATERIAL CROSS-SECTION WAS DETERMINED. A WEAKENING OF THE CUTTER HEAD 60030408 DUE TO A TOO SMALL MATERIAL CROSS SECTION COULD NOT BE DETERMINED. 2.5 MATERIAL OR HARDNESS REVIEW: THE HARDNESS 52 +4/0 HRC OF COMPONENT CUTTER HEAD 60030408 HAS BEEN MEASURED. THE ACTUAL HARDNESS IS 53.9 HRC; THIS VALUE IS WITHIN SPECIFICATION. IN ACCORDANCE TO THIS TEST RESULT AND THE ASSEMBLED COMPONENTS, AS LISTED ON DEVICE HISTORY RECORD, IT CAN BE DETERMINED THAT THE CORRECT RAW-MATERIAL HAS BEEN USED. 4.2 CONCLUSION ACCORDING TO THE TEST RESULTS, THE HARDNESS AND THE MATERIAL CROSS-SECTION AT BREAKAGE, NO REDUCED STRENGTH OF THE CUTTER HEAD 60030408 WAS DETERMINED. THEREFORE, IT MUST BE ASSUMED THAT MECHANICAL OVERLOAD HAS LED TO MALFUNCTION AND BREAKAGE OF THE CUTTER HEAD ON THE APPLIC-INSTR F/STERNAL ZIPFIX 03.501.080. 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. 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 · 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. THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. 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

    PATIENT INFORMATION IS NOT AVAILABLE FOR REPORTING. 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. (B)(4). THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED AND IS CURRENTLY PENDING COMPLETION. 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 CORONARY ARTERY BYPASS GRAFTING PROCEDURE ON (B)(6) 2018, THE STEEL PART OF THE CUTTING LEVER OF AN APPLICATION INSTRUMENT FOR STERNAL ZIPFIX OBSERVED TO BE CHIPPED OFF NEAR THE TIP. THE DEFECT IN THE DEVICE WAS OBSERVED AT THE TIME OF CLOSURE WHEREIN A SMALL PORTION OF THE STEEL AT THE TIP WAS MISSING AT THE TIME OF APPLICATION AND APPEARED TO HAVE BEEN CHIPPED OFF BEFORE USING IN THE PATIENT. THE SURGEON USED A STEELWIRE IN PLACE OF THE ZIPFIX IMPLANTS FOR STERNUM CLOSURE. THERE WAS A SURGICAL DELAY OF APPROXIMATELY TWENTY (20) MINUTES. PATIENT AND SURGICAL OUTCOME IS UNKNOWN. CONCOMITANT DEVICE REPORTED: UNKNOWN ZIPFIX IMPLANT (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY UNKNOWN). THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    549198 APPLICATION INSTRUMENT FOR STERNAL ZIPFIX CERCLAGE FIXATION JDQ OBERDORF SYNTHES PRODUKTIONS GMBH 03.501.080 9790420 10887587010847

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention