BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APPLICATION INSTRUMENT FOR STERNAL ZIPFIX

    MDR report key: 8869149 · Received August 7, 2019

    Report

    Report Number
    8030965-2019-66927
    Event Type
    Malfunction
    Date Received
    August 7, 2019
    Date of Event
    July 9, 2019
    Report Date
    July 9, 2019
    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
    PHYSICIAN

    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. H3, H4, H6: A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED: PART: 03.501.080, LOT: L910437, MANUFACTURING SITE: HÄGENDORF, RELEASE TO WAREHOUSE DATE: 26.JUNE 2018. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. H3, H6: A PRODUCT INVESTIGATION WAS CONDUCTED. VISUAL INSPECTION: THE DEVICE DOES APPEAR TO HAVE A BROKEN PORTION. COMPONENT 60030408 IS BROKEN. THE DEVICE APPEARS TO HAVE NO OTHER DAMAGE. DOCUMENT/SPECIFICATION REVIEW: THE OVERALL ASSEMBLY DRAWING AND THE INDIVIDUAL COMPONENT DRAWINGS WERE REVIEWED. THE COMPONENT IS MEANT TO BE COMPLETE AND SYMMETRICAL, IN ORDER TO FUNCTION PROPERLY. ADDITIONALLY, A TEST WAS PERFORMED TO ENSURE THE PART WOULD CONTINUE TO PERFORM AS EXPECTED AFTER MULTIPLE CLINICAL REPROCESSING CYCLES. THIS TEST WAS DOCUMENTED ON SE_508847 AND SHOWS THAT THE DEVICE SHOULD PERFORM AS EXPECTED. DIMENSIONAL INSPECTION: BROKEN PORTION WAS NOT RETURNED; THEREFORE, NO DIMENSIONAL INSPECTION CAN BE ACCURATELY PERFORMED. SUMMARY: IN SUMMARY, THE PART WAS RECEIVED BACK IN A BROKEN CONDITION. AFTER REVIEW OF THE DRAWINGS AND SUPPORTING DOCUMENTATION, NO DESIGN RELATED ROOT CAUSE COULD BE IDENTIFIED. TESTING WAS CONDUCTED TO SHOW THE ABILITY OF THE DEVICE TO PERFORM APPROPRIATELY AFTER MULTIPLE USES AND REPROCESSING CYCLES. 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 · 1

    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. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. 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 (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING AN AORTIC ANEURYSM PROCEDURE ON (B)(6) 2019, THE TIP OF THE ZIPFIX STERNAL CLOSURE SYSTEM BROKE DOWN AND THE SURGEON REMOVED IT. THE SURGEON USED THE CONVENTIONAL CUTTER TO CUT THE BAND. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A FIFTEEN (15) MINUTES SURGICAL DELAY. NO ADDITIONAL INTERVENTION REPORTED. THE PATIENT IS FINE AND HAS BEEN DISCHARGED. THIS REPORT IS FOR AN APPLICATION INSTRUMENT FOR STERNAL ZIPFIX. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    665445 APPLICATION INSTRUMENT FOR STERNAL ZIPFIX CERCLAGE FIXATION JDQ OBERDORF SYNTHES PRODUKTIONS GMBH L910437 07611819418424

    Patients

    Seq Age Sex Outcome Treatment
    1