BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APPLICATION INSTRUMENT FOR STERNAL ZIPFIX

    MDR report key: 9220716 · Received October 22, 2019

    Report

    Report Number
    2939274-2019-61696
    Event Type
    Malfunction
    Date Received
    October 22, 2019
    Report Date
    October 7, 2019
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    JDQ
    UDI-DI
    10887587010847
    PMA / PMN Number
    K110789
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    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. PART: 03.501.080-US. LOT: 9812895. MANUFACTURING SITE: HÄGENDORF. RELEASE TO WAREHOUSE DATE: 05. FEB. 2016. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. SERVICE EVALUATION: THE CUSTOMER REPORTED THE DEVICE WOULD NOT TENSION PROPERLY. THE ITEM PASSED TESTING PER THE INSPECTION SHEET AND WORKED WITHIN NORMAL PARAMETERS. THE COMPLAINED ISSUE WAS NOT ABLE TO BE REPRODUCED. THE CAUSE OF THE COMPLAINED ISSUE IS UNKNOWN. THE ITEM PASSED SYNTHES FINAL INSPECTION ON 29-OCT-2019 AND WILL BE RETURNED TO THE CUSTOMER UPON COMPLETION OF THE SERVICE AND REPAIR PROCESS. ATTACHED SERVICE RECORD COMPLETED. FINALIZED SERVICE RECORD WILL BE ARCHIVED IN DOCUMENT MANAGEMENT SYSTEM. THE EVALUATION WAS UNCONFIRMED. THE DEVICE WAS DEEMED SERVICEABLE AND WILL BE RETURNED TO THE CUSTOMER, NO DESIGN OR MANUFACTURING ISSUES WERE IDENTIFIED THEREFORE 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

    REPORTER IS SYNTHES SALES CONSULTANT. THE DEVICE HAS BEEN RECEIVED, THE INVESTIGATION IS IN PROGRESS, NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING THIS REPORT. 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

    IT WAS REPORTED THAT ON (B)(6) 2019, THE APPLICATION INSTRUMENT FOR STERNAL ZIPFIX WILL NOT TENSION PROPERLY. THE ISSUE WAS OBSERVED DURING TESTING/CLEANING. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) APPLICATION INSTRUMENT FOR STERNAL ZIPFIX. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1013289 APPLICATION INSTRUMENT FOR STERNAL ZIPFIX CERCLAGE FIXATION JDQ WRIGHTS LANE SYNTHES USA PRODUCTS LLC 03.501.080 9812895 10887587010847

    Patients

    Seq Age Sex Outcome Treatment
    1