BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRIVER

    MDR report key: 8669857 · Received June 5, 2019

    Report

    Report Number
    0001038806-2019-00470
    Event Type
    Malfunction
    Date Received
    June 5, 2019
    Date of Event
    November 21, 2018
    Report Date
    August 30, 2019
    Manufacturer
    BIOMET 3I
    Product Code
    DZE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMMERBIOMET COMPLAINT NUMBER (B)(4). UNKNOWN BIOMET DRIVER WAS NOT RETURNED. SINCE THE UNKNOWN BIOMET DRIVER HAS NOT BEEN RETURNED, VISUAL/FUNCTIONAL INSPECTION COULD NOT BE PERFORMED. THE INVESTIGATION HAS BEEN PERFORMED BASED ON THE AVAILABLE INFORMATION USING THE PRODUCT FAMILY (IFU/RMF) DOCUMENTS REVIEWED: INSTRUCTIONS FOR USE FOR BIOMET 3I KITS AND INSTRUMENTS (P-ZBDINSTRP) REV. B - JULY 2018 INFORMATION IDENTIFIED: "WARNINGS AND PRECAUTION" DHR REVIEW AND COMPLAINT HISTORY REVIEW COULD NOT BE PERFORMED, AS THE LOT NUMBER ASSOCIATED WITH THE REPORTED PRODUCT (UNKNOWN BIOMET DRIVER) IS NOT AVAILABLE. ZIMMER BIOMET QUALITY MANAGEMENT SYSTEM (QMS) HAS CONTROLS IN PLACE TO ENSURE THE DISTRIBUTION OF CONFORMING PRODUCT WITHIN SPECIFICATIONS. A COMPLAINT HISTORY REVIEW BY ITEM NUMBER OR LOT NUMBER COULD NOT BE CONDUCTED FOR THE UNKNOWN BIOMET DRIVER. THEREFORE, BASED ON THE AVAILABLE INFORMATION, DEVICE COULD NOT BE VERIFIED FOR THE UNKNOWN BIOMET DRIVER AND THE REPORTED EVENT WAS U NON-VERIFIABLE. RISK ASSOCIATED WITH THE REPORTED PRODUCT (UNKNOWN BIOMET DRIVER) AND EVENT IS MOST APPLICABLY DEFINED AND ADDRESSED IN RISK MANAGEMENT FILES PROJECT 223-625 DFMEA REV 19 & RM-00274-HAZ REV 1. A DEFINITIVE CAUSE COULD NOT BE IDENTIFIED. HOWEVER, THE PROBABLE CAUSES AND MAX OCCURRENCES HAVE BEEN CONSIDERED FOR DOES NOT ASSEMBLE. 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.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IMPLANT WAS PICKED UP BY THE DRIVER AND DROPPED DOWN WHILE MOVING. THE SURGERY WAS COMPLETED USING ANOTHER IMPLANT. TOOTH LOCATION 12.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    464294 DRIVER DZE BIOMET 3I

    Patients

    Seq Age Sex Outcome Treatment
    1