BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NARROW STANDARD LARGE HEXED DRIVER, 24MM

    MDR report key: 17993239 · Received October 23, 2023

    Report

    Report Number
    0001038806-2023-02044
    Event Type
    Malfunction
    Date Received
    October 23, 2023
    Date of Event
    August 1, 2023
    Report Date
    March 18, 2024
    Manufacturer
    BIOMET 3I
    Product Code
    NDP
    UDI-DI
    00844868014287
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4).

    Additional Manufacturer Narrative · 0

    ZIMVIE RECEIVED ONE (1) PHD03N, (NARROW STANDARD LARGE HEXED DRIVER, 24MM) FOR EVALUATION. VISUAL EVALUATION WAS PERFORMED, THE HEX DRIVERS TIP WAS FRACTURED. FRACTURED TIP NOT RETURNED. DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER 1250517. NO DEVIATIONS OR NON-CONFORMANCES, WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT, WERE NOTED AS PART OF THE DHR. COMPLAINT HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT NUMBER 1250517 FOR SIMILAR EVENTS AND NO OTHER COMPLAINT WAS IDENTIFIED. REVIEW COMPLETED UTILIZING KEYWORDS: ¿DENTAL : FUNCTIONAL : FRACTURE¿ THE CUSTOMER DID NOT SUBMIT IMAGES FOR THE REPORTED EVENT. BASED ON THE INVESTIGATION AND RISK MANAGEMENT FILE REVIEW AS PER RM-00291-HAZ, THE MOST LIKELY ROOT CAUSE DETERMINED FROM THE INVESTIGATION WAS THE MATERIAL SELECTION WAS NOT ADEQUATE TO WITHSTAND RECOMMENDED TORQUE VALUES. THEREFORE, BASED ON THE AVAILABLE INFORMATION, A DEVICE MALFUNCTION DID OCCUR. THE DRIVER¿S TIP WAS FRACTURED. THE REPORTED EVENT WAS CONFIRMED. NO FURTHER INVESTIGATION OR IMMEDIATE CAPA / HHE/D ESCALATION IS REQUIRED, AS THE COMPLAINT INVESTIGATION DID NOT CONFIRM THE PRODUCTS WERE NONCONFORMING AT THE TIME OF DISTRIBUTION, AND NO NEW FAILURE MODE, HARM, OR HAZARDOUS SITUATION WAS IDENTIFIED THROUGH THE INVESTIGATION PERFORMED. AT THIS TIME, THE COMPLAINT INVESTIGATION HAS BEEN COMPLETED AND THE RECORD WILL BE CLOSED. IF ADDITIONAL INFORMATION IS RECEIVED, THE RECORD WILL BE RE-OPENED FOR FURTHER EVALUATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DRIVER FRACTURED AT THE TIP. ANOTHER DRIVER WAS USED.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2110992 NARROW STANDARD LARGE HEXED DRIVER, 24MM DENTAL DRIVER NDP BIOMET 3I 1250517 00844868014287

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Prefer Not To Disclose