BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NARROW STANDARD LARGE HEXED DRIVER, 24MM

    MDR report key: 9540446 · Received January 2, 2020

    Report

    Report Number
    0001038806-2020-00007
    Event Type
    Malfunction
    Date Received
    January 2, 2020
    Report Date
    March 31, 2020
    Manufacturer
    BIOMET 3I
    Product Code
    NDP
    PMA / PMN Number
    1
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 0

    A NARROW STANDARD LARGE HEXED DRIVER, 24MM (PHD03N) WAS RETURNED FOR INVESTIGATION, VISUAL INSPECTION OF THE AS RETURNED PRODUCT IDENTIFIED THE TIP TO BE FRACTURED. FUNCTIONAL TESTING TO RECREATE THE REPORTED EVENT COULD NOT BE PERFORMED DUE TO THE NATURE OF THE DEVICE AND EVENT. PRE-EXISTING PATIENT FACTORS, X-RAY, TOOTH LOCATION ARE NOT RELEVANT TO THE REPORTED EVENT. THE LENGTH OF THE DEVICE USAGE IS UNKNOWN. PICTURES OR X-RAY IMAGES WERE NOT PROVIDED. DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER (1211042). 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 (1211042) FOR SIMILAR EVENT AND NO OTHER COMPLAINT WAS IDENTIFIED. JANUARY POST MARKET TRENDING WAS REVIEWED AND THERE WERE NO ACTIONABLE EVENTS OR CORRECTIVE ACTIONS FOR THE REPORTED EVENT OR DEVICE. BASED ON THE AVAILABLE INFORMATION, DEVICE MALFUNCTION DID OCCUR AND THE REPORTED EVENT WAS CONFIRMED. THE FOLLOWING SECTIONS HAVE BEEN UPDATED: B4: DATE OF THIS REPORT. D4: UNIQUE IDENTIFIER (UDI) NUMBER. D10: DEVICE AVAILABILITY. G4: DATE RECEIVED BY MANUFACTURER. G7: CHECKED "FOLLOW-UP". H2: CHECKED FOLLOW-UP TYPE. H3: DEVICE EVALUATED BY MANUFACTURER. H4: MANUFACTURER DATE. H6: ENTERED EVALUATION CODES. H10: ADDED MANUFACTURER NARRATIVE.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET (B)(4). AGE AND DATE OF BIRTH UNKNOWN / NOT PROVIDED. PATIENT SEX UNKNOWN / NOT PROVIDED. WEIGHT UNKNOWN / NOT PROVIDED. DATE OF EVENT UNKNOWN / NOT PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DRIVER FRACTURED. ANOTHER DRIVER WAS USED TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    4153 NARROW STANDARD LARGE HEXED DRIVER, 24MM DRIVER NDP BIOMET 3I 1211042

    Patients

    Seq Age Sex Outcome Treatment
    1