BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XRL RELEASE TOOL

    MDR report key: 12361397 · Received August 24, 2021

    Report

    Report Number
    8030965-2021-07138
    Event Type
    Malfunction
    Date Received
    August 24, 2021
    Report Date
    July 28, 2021
    Manufacturer
    SYNTHES GMBH
    Product Code
    MQP
    UDI-DI
    10705034723242
    PMA / PMN Number
    K103320
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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, H4, H6: PART 03.807.348, LOT 8910006: MANUFACTURING SITE: HAGENDORF. RELEASE TO WAREHOUSE DATE: MAY 26, 2014. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED ARTICLE LOT AND NO NON-CONFORMANCES WERE IDENTIFIED. H3, H6: A PRODUCT INVESTIGATION WAS COMPETED: UPON VISUAL INSPECTION, THERE WAS NO ISSUES WERE OBSERVED WITH THE RETURNED DEVICE. A FUNCTIONAL ASSESSMENT WAS PERFORMED ON THE COMPLAINT DEVICE WITH THE RELEVANT MATING DEVICES. THE DEVICES WERE ABLE TO DISASSEMBLE AND ASSEMBLE WITHOUT ANY ISSUES. ALSO, THE LOCKING MECHANISM WORKED AS INTENDED. THE RETAINING COLLAR RETRACTED PROPERLY. NO IMPLANT WAS RECEIVED WITH THE COMPLAINT DEVICES. A DIMENSIONAL INSPECTION WAS NOT PERFORMED AS THE INTERNAL COMPONENTS WERE INACCESSIBLE WITHOUT DESTRUCTION OF THE DEVICE. BASED ON THE DATE OF MANUFACTURE, THE CURRENT AND MANUFACTURED REVISION OF DRAWINGS WERE REVIEWED; NO DESIGN ISSUES OR DISCREPANCIES WERE IDENTIFIED. THE COMPLAINT WAS NOT CONFIRMED AS THE DEVICE WORKED AS INTENDED. 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

    REPORTER IS A SYNTHES EMPLOYEE. 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

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN THE (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE INSTRUMENT WAS DIFFICULT TO WORK WITH AND BECAME STUCK. THE ISSUE WAS DISCOVERED PRIOR TO A PROCEDURE. THIS REPORT INVOLVES ONE (1) XRL RELEASE TOOL. THIS IS REPORT 2 OF 3 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1254859 XRL RELEASE TOOL SPINAL VERTEBRAL BODY REPLACEMENT DEVICE MQP SYNTHES GMBH 03.807.348 8910006 10705034723242

    Patients

    Seq Age Sex Outcome Treatment
    1