BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MATRIXMANDIBLE 1.5MM DRILL BIT J-LATCH/90MM FOR 03.503.043

    MDR report key: 11012055 · Received December 15, 2020

    Report

    Report Number
    2939274-2020-05582
    Event Type
    Malfunction
    Date Received
    December 15, 2020
    Date of Event
    November 18, 2020
    Report Date
    November 18, 2020
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    DZI
    UDI-DI
    10887587012919
    PMA / PMN Number
    K043310
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHESE IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHESE HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHESE OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHESE, 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. PART NUMBER:03.503.451. SYNTHESE LOT NUMBER: U253056. SUPPLIER LOT NUMBER: N/A. RELEASE TO WAREHOUSE DATE: OCTOBER 24, 2016. EXPIRATION DATE: N/A. SUPPLIER: ORCHID UNIQUE. NO NCRS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT, AND ANY SUBCOMPONENTS, WHICH WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND 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. 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

    COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. REPORTER IS A SYNTHES EMPLOYEE. 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. 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 (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020 DURING A MANDIBULAR RAMUS FX OSTEOSYNTHESIS AND LEFT MAXILLARY CONDYLE OSTEOTOMY THAT THE DRILL BROKE INTRAOPERATIVELY. THERE WAS NO HARM TO THE PATIENT. THIS REPORT IS FOR ONE (1) MATRIXMANDIBLE 1.5MM DRILL BIT J-LATCH/90MM FOR 03.503.043. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1477094 MATRIXMANDIBLE 1.5MM DRILL BIT J-LATCH/90MM FOR 03.503.043 DRILL, BONE, POWERED DZI WRIGHTS LANE SYNTHES USA PRODUCTS LLC 03.503.451 U253056 10887587012919

    Patients

    Seq Age Sex Outcome Treatment
    1