BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APPLICATION INSTRUMENT FOR SNAL ZIPFIX

    MDR report key: 11558025 · Received March 23, 2021

    Report

    Report Number
    2939274-2021-01497
    Event Type
    Malfunction
    Date Received
    March 23, 2021
    Date of Event
    February 19, 2021
    Report Date
    February 24, 2021
    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
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    REPORTER IS A J&J SALES REPRESENTATIVE. A PRODUCT INVESTIGATION WAS CONDUCTED. SERVICE AND REPAIR EVALUATION: IT WAS REPORTED THAT ON (B)(6) 2021, THE APPLICATION INSTRUMENT FOR STERNAL ZIPFIX WAS NO GRABBING. THE ITEM PASSED TESTING PER THE INSPECTION SHEET AND WORKED WITHIN NORMAL PARAMETERS. THE COMPLAINED ISSUE WAS NOT ABLE TO BE REPRODUCED. LUBE/OIL/CLEAN IS THE REASON FOR REPAIR. THE CAUSE OF THE COMPLAINED ISSUE IS TEST OK. THE ITEM PASSED SYNTHES FINAL INSPECTION ON 11-MAR-2021 AND WILL BE RETURNED TO THE CUSTOMER UPON COMPLETION OF THE SERVICE AND REPAIR PROCESS. THE EVALUATION WAS UNCONFIRMED. THE DEVICE 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. LOT: 9812895. MANUFACTURING SITE: (B)(4). 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. 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) 2021, THE APPLICATION INSTRUMENT FOR STERNAL ZIPFIX WAS NOT GRABBING. IT IS UNKNOWN WHEN THE ISSUE WAS OBSERVED. IT IS UNKNOWN IF THERE WAS PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) APPLICATION INSTRUMENT FOR SNAL ZIPFIX. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    453882 APPLICATION INSTRUMENT FOR SNAL ZIPFIX CERCLAGE, FIXATION JDQ WRIGHTS LANE SYNTHES USA PRODUCTS LLC 03.501.080 9812895 10887587010847

    Patients

    Seq Age Sex Outcome Treatment
    1