BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 17896245 · Received October 9, 2023

    Report

    Report Number
    8030965-2023-12741
    Event Type
    Malfunction
    Date Received
    October 9, 2023
    Date of Event
    August 24, 2023
    Manufacturer
    SYNTHES GMBH
    Product Code
    DZI
    UDI-DI
    10887587012919
    PMA / PMN Number
    K043310
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    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. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT, AND ANY SUB-COMPONENTS, WHICH WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. PART # 03.503.451 SYNTHES LOT # U253056, SUPPLIER LOT # U253056, RELEASE TO WAREHOUSE DATE: 12 APR 2017, SUPPLIER: (B)(4), NO NCRS WERE GENERATED DURING PRODUCTION. THE PRODUCT WAS RETURNED TO DEPUY SYNTHES FOR EVALUATION. THE DEPUY SYNTHES TEAM CONDUCTED A VISUAL INSPECTION OF THE RETURNED DEVICE. VISUAL ANALYSIS OF THE RETURNED SAMPLE REVEALED THAT THE FLUTED TIP OF MATRIXMAND 1.5 DB J-LATCH/90 03.503.043 WAS BROKEN. THE BROKEN FRAGMENT WAS RETURNED FOR EVALUATION. BOTH OF THE BROKEN FRAGMENTS EXHIBIT SIGNS OF EXCESSIVE FRICTION. THE ROOT CAUSE IS BEING ATTRIBUTED TO UNINTENDED USE. A DIMENSIONAL INSPECTION WAS NOT PERFORMED AS IT IS NOT APPLICABLE TO THE COMPLAINT CONDITION. AS PART OF DEPUY SYNTHES QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. THE OVERALL COMPLAINT WAS CONFIRMED AS THE OBSERVED CONDITION OF THE MATRIXMAND 1.5 DB J-LATCH/90 03.503.043 WOULD CONTRIBUTE TO THE COMPLAINED DEVICE ISSUE. THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE COMPLAINT CONDITION. 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.

    Description of Event or Problem · 0

    DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6)2023, THE PATIENT UNDERWENT AN ORIF SURGERY TREATING A MANDIBULAR FRACTURE. DURING THE PROCEDURE WHILE USING THE DRILL SLEEVE, IT BECAME HOT AND CAUSE BURNS ON THE PATIENT¿S ORAL MUCOSA. WHEN THE DRILL BIT WAS REMOVED FROM THE SLEEVE, IT WAS FOUND THAT THE DRILL BIT WAS DAMAGED IN THE MIDDLE SECTION. IT WAS CONCLUDED THAT THE DRILL BIT WAS BEING HELD AGAINST THE SLEEVE, WHICH GENERATED HEAD DUE TO ROTATIONAL FRICTION. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. THE PATIENT EXPERIENCED SOME BURNS IN THEIR MOUTH BUT IS IN A STABLE CONDITION, NO PROBLEMS HAVE BEEN OBSERVED. NO FURTHER INFORMATION IS AVAILABLE TO REPORT. THIS REPORT IS FOR A 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
    942305 MATRIXMANDIBLE 1.5MM DRILL BIT J-LATCH/90MM FOR 03.503.043 DRILL, BONE, POWERED DZI SYNTHES GMBH U253056 10887587012919

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown