BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FRONT CUTTER

    MDR report key: 12070196 · Received June 25, 2021

    Report

    Report Number
    8030965-2021-05332
    Event Type
    Malfunction
    Date Received
    June 25, 2021
    Report Date
    May 29, 2021
    Manufacturer
    SYNTHES GMBH
    Product Code
    HXZ
    UDI-DI
    07611819880313
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE 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. H3, H6: VISUAL INSPECTION: THE FRONT CUTTER (P/N: 03.607.513, LOT NUMBER: 8853146) WAS RECEIVED AT US CUSTOMER QUALITY (CQ). VISUAL INSPECTION OF THE COMPLAINT DEVICE SHOWED ONE OF THE JAWS HAD BROKEN OFF THE FRONT CUTTER. DEVICE FAILURE/DEFECT IDENTIFIED? YES. DIMENSIONAL INSPECTION: A DIMENSIONAL INSPECTION WAS NOT PERFORMED DUE TO POST-MANUFACTURING DAMAGE. DOCUMENT/SPECIFICATION REVIEW: CURRENT AND MANUFACTURED WERE REVIEWED. NO DESIGN ISSUES OR DISCREPANCIES WERE IDENTIFIED. COMPLAINT CONFIRMED? YES. INVESTIGATION CONCLUSION: THIS COMPLAINT IS CONFIRMED AS THE JAW HAD BROKEN OFF. NO DEFINITIVE ROOT CAUSE COULD BE DETERMINED BASED ON THE PROVIDED INFORMATION. THERE WAS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE CONTRIBUTED TO THE COMPLAINT. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST MARKET SAFETY SURVEILLANCE ACTIVITIES. 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

    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. CUSTOMER QUALITY INVESTIGATION: THE DEVICE WAS NOT RETURNED. A PHOTO-INVESTIGATION WAS PERFORMED ON THE IMAGES. UPON INSPECTING THE IMAGES PROVIDED, IT WAS OBSERVED ONE OF THE JAWS HAD BROKEN OFF THE FRONT CUTTER. HOWEVER, THE ROOT CAUSE OF THE BREAKAGE CANNOT BE DETERMINED BASED ON THE AVAILABLE IMAGE. NO OTHER ISSUES WERE NOTED. AS THE DEVICE WAS NOT RETURNED, AN AS-RECEIVED CONDITION COULD NOT BE ASSESSED, AND A DIMENSIONAL INSPECTION AND DOCUMENT/SPECIFICATION REVIEW WERE NOT COMPLETED. CONCLUSION: THE COMPLAINT CONDITION CAN BE CONFIRMED DURING PHOTO INVESTIGATION. DURING THE INVESTIGATION, NO PRODUCT DESIGN ISSUES, OR DISCREPANCIES WERE OBSERVED. NO MANUFACTURING ISSUES WERE NOTED DURING INVESTIGATION. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST MARKET SAFETY SURVEILLANCE ACTIVITIES. THEREFORE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTIVE ACTION IS PROPOSED. DEVICE HISTORY LOT: (B)(6) 2021: DHR REVIEW FOR THE FOLLOWING DEVICE WAS CONDUCTED AT MANUFACTURING SITE (B)(4) BY SITE LEAD QUALITY ASSURANCE (B)(6) (NT ID (B)(6)). PART # 03.607.513, LOT # 8853146. DEVICE HISTORY REVIEW: MANUFACTURING DATE: (B)(6) 2014: A DHR REVIEW WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER AND THE PRODUCTION WAS ACCORDING TO THE REQUIREMENTS AND NO NON-CONFORMANCE WAS IDENTIFIED. THE MATERIAL USED WAS ACCORDING TO SPECIFICATION AND WITHIN PRODUCTION 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 REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT, ONE SIDE OF THE JAW AREA HAS SNAPPED OF THE FRONT CUTTER. THIS CASE HAS BEEN REPORTED BY THE LOAN KIT TECHNICIAN DURING LOAN KIT INSPECTION. IT HAS BEEN FORWARDED TO DEPUY ENGINEERING FOR ASSESSMENT. THIS REPORT IS FOR ONE (1). THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    964336 FRONT CUTTER CUTTER, WIRE HXZ SYNTHES GMBH 8853146 07611819880313

    Patients

    Seq Age Sex Outcome Treatment
    1