BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APPLICATION INSTRUMENT FOR STERNAL ZIPFIX

    MDR report key: 9328610 · Received November 15, 2019

    Report

    Report Number
    2939274-2019-62221
    Event Type
    Malfunction
    Date Received
    November 15, 2019
    Date of Event
    October 30, 2019
    Report Date
    October 31, 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
    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. A PRODUCT INVESTIGATION WAS CONDUCTED. SERVICE & REPAIR EVALUATION: THE CUSTOMER REPORTED APPLICATION INSTRUMENT FOR STERNAL ZIPFIX WAS FOUND TO BE FAULTY. THE APPLICATOR DID NOT PROPERLY TIGHTEN THE STERNAL ZIPFIX. 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 WILL BE RETURNED TO THE CUSTOMER UPON COMPLETION OF THE SERVICE AND REPAIR PROCESS. 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. A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED: PART: 03.501.080-US. LOT: 9812895. MANUFACTURING SITE: (B)(4). RELEASE TO WAREHOUSE DATE: (B)(6) 2016. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. 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. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. 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 · 0

    CONCOMITANT DEVICE REPORTED: UNKNOWN STERNAL ZIPFIX (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# UNKNOWN).

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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 DURING STERNAL CLOSURE IN OPEN-HEART SURGERY ON AN UNKNOWN DATE, AN APPLICATION INSTRUMENT FOR STERNAL ZIPFIX WAS FOUND TO BE FAULTY. THE APPLICATOR DID NOT PROPERLY TIGHTEN THE STERNAL ZIPFIX. THE SURGEON SIMPLY USED ANOTHER DEVICE TO PROPERLY SECURE THE IMPLANTS. THE SURGERY WAS COMPLETED WITH NO ADVERSE CONSEQUENCE TO THE PATIENT. CONCOMITANT DEVICE REPORTED: UNKNOWN STERNAL ZIPFIX (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# UNKNOWN); CONCOMITANT DEVICE REPORTED: UNKNOWN PLATE (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY # 1). THIS REPORT IS FOR ONE (1) 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
    1123803 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 UNK - ZIPFIX IMPLANTS| UNK - ZIPFIX IMPLANTS