BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CERTAIN 3.4MM(D) DRIVER TIP - SHORT

    MDR report key: 11391713 · Received March 1, 2021

    Report

    Report Number
    0001038806-2021-00343
    Event Type
    Injury
    Date Received
    March 1, 2021
    Date of Event
    January 27, 2021
    Report Date
    June 7, 2021
    Manufacturer
    BIOMET 3I
    Product Code
    NDP
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4). ONE CERTAIN® IMPLANT DRIVER TIP - SHORT (IIPDTS), ONE CERTAIN® IMPLANT DRIVER TIP ¿ LONG (IIPDTL), AND TWO CERTAIN® 3.4MM(D) DRIVER TIP ¿ SHORT WERE RETURNED FOR INVESTIGATION. VISUAL EVALUATION OF THE AS RETURNED PRODUCTS IDENTIFIED SIGNS OF WEAR ON THE DEVICES DUE TO USAGE BUT NO APPARENT SIGNS OF MALFUNCTION. DEVICE HISTORY RECORD (DHR) REVIEW COULD NOT BE PERFORMED AS THE LOT NUMBERS WERE NOT AVAILABLE. HOWEVER, ZIMMER BIOMET QUALITY MANAGEMENT SYSTEM (QMS) HAS CONTROLS IN PLACE TO ENSURE THE DISTRIBUTION OF CONFORMING PRODUCTS WITHIN SPECIFICATIONS. A YEAR-LONG COMPLAINT HISTORY REVIEW WAS PERFORMED BY ITEMS (IIPDTS, IIPDTL & IMPDTS) AND NO OTHER COMPLAINTS ABOUT NONCONFORMING PRODUCTS WERE IDENTIFIED. HOWEVER, COMPLAINT HISTORY REVIEW COULD NOT BE PERFORMED FOR THE UNKNOWN IMPLANT AS THE LOT/ITEM NUMBER WAS UNKNOWN. THEREFORE, BASED ON THE AVAILABLE INFORMATION AND FUNCTIONAL TESTING, DRIVER MALFUNCTION DID NOT OCCUR.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4).

    Description of Event or Problem · 1

    DOCTOR REPORTED THE DRIVERS HOLD THE IMPLANT BUT AT THE MOMENT OF PLACING THE IMPLANT THEY DOES NOT DISENGAGE FROM THE IMPLANT. DOCTOR DID NOT FINISHED THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    292031 CERTAIN 3.4MM(D) DRIVER TIP - SHORT DENTAL INSTRUMENT NDP BIOMET 3I

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention