BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NARROW RIGHT ANGLE LARGE HEX DRIVER TIP 30MM

    MDR report key: 10693779 · Received October 16, 2020

    Report

    Report Number
    0001038806-2020-01590
    Event Type
    Malfunction
    Date Received
    October 16, 2020
    Date of Event
    August 30, 2020
    Report Date
    January 15, 2021
    Manufacturer
    BIOMET 3I
    Product Code
    NDP
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ONE NARROW RIGHT ANGLE LARGE HEX DRIVER TIP 30MM (RASH8N) WAS RETURNED FOR INVESTIGATION. VISUAL INSPECTION OF THE AS RETURNED PRODUCT IDENTIFIED THAT THE DRIVER TIP AND LATCHLOCK ARE MODERATELY WORN, WHILE THE BODY OF THE DRIVER IS FRACTURED LATERALY. THE REPORTED EVENT COULD NOT BE RECREATED DUE TO THE NATURE OF THE DENTAL DEVICE AND EVENT (FRACTURE). DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER 1152175. IT WAS CONFIRMED THAT ALL OPERATIONS AND INSPECTIONS WERE EXECUTED AS PER APPLICABLE PROCEDURE. NO DEVIATIONS OR NON-CONFORMANCES, WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT WAS NOTED AS PART OF THE DHR. LOT WAS INSPECTED AND PASSED ALL ACCEPTANCE CRITERIA BY QA. COMPLAINT HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT NUMBER (1152175) FOR SIMILAR EVENT AND NO OTHER COMPLAINT WAS IDENTIFIED. NOVEMBER POST MARKET TRENDING WAS REVIEWED AND THERE WERE NO ACTIONABLE EVENTS OR CORRECTIVE ACTIONS FOR THE REPORTED EVENT (COMPONENT FRACTURE) OR PRODUCT (RASH8N). THEREFORE, BASED ON THE AVAILABLE INFORMATION, DEVICE MALFUNCTION HAS OCCURRED AND THE REPORTED EVENT WAS CONFIRMED.

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN RELAYED TO CORRECT AND ERROR IN THE PREVIOUSLY REPORTED SUBMISSION (MFR# 0001038806-2020-01590-1).

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT. SEE H10 FOR CORRECTION DETAILS.

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET (B)(4). AGE: NOT PROVIDED. PATIENT WEIGHT: NOT PROVIDED. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DRIVER TIP (RASH8N) FRACTURED DURING A SECOND NORMAL USED. DOCTOR DID NOT FIND ANY PRODUCT QUALITY AND NO HEALTH HAZARD WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1154848 NARROW RIGHT ANGLE LARGE HEX DRIVER TIP 30MM DRIVER TIP NDP BIOMET 3I 1152175

    Patients

    Seq Age Sex Outcome Treatment
    1