BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DENTAL DRIVER

    MDR report key: 18908483 · Received March 14, 2024

    Report

    Report Number
    0001038806-2024-00451
    Event Type
    Malfunction
    Date Received
    March 14, 2024
    Date of Event
    January 1, 2024
    Report Date
    August 13, 2024
    Manufacturer
    BIOMET 3I
    Product Code
    NDP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMVIE COMPLAINT NUMBER (B)(4).

    Additional Manufacturer Narrative · 0

    ZIMVIE DID NOT RECEIVE ONE (1) UNKNOWN PLACEMENT WRENCH FOR EVALUATION. VISUAL INSPECTION COULD NOT BE PERFORMED. THE INVESTIGATION HAS BEEN PERFORMED BASED ON THE AVAILABLE INFORMATION USING THE ITEM NUMBER, AND RISK MANAGEMENT FILE (RMF). FUNCTIONAL TESTING TO RECREATE THE REPORTED EVENT COULD NOT BE PERFORMED DUE TO THE NATURE OF THE DEVICE & EVENT. THIS COMPLAINT REFERS TO THE SPECIFIC DEVICE BEING INVESTIGATED FOR THIS COMPLAINT RECORD. DHR, STERILIZATION, AND COMPLAINT HISTORY REVIEW COULD NOT BE PERFORMED, AS THE SUBJECT LOT NUMBER ASSOCIATED WITH THE UNKNOWN PLACEMENT WRENCH IS NOT AVAILABLE. ZIMVIE QUALITY MANAGEMENT SYSTEM (QMS) HAS CONTROLS IN PLACE TO PREVENT THE DISTRIBUTION OF NON-CONFORMING PRODUCT AND ENSURE THE PRODUCT IS WITHIN SPECIFICATIONS. THE CUSTOMER DID NOT SUBMIT IMAGES FOR THE REPORTED EVENT. IFU REVIEW: REVIEW OF APPROPRIATE DOCUMENTATION: DOCUMENT REVIEWED: INSTRUCTIONS FOR USE - ZIMMER INSTRUMENT KIT SYSTEM, ZIMMER DENTAL SINGLE PATIENT DRILLS, DRIVA DRILLS, AND TOOLS, IFU 8874 REV. 6 - 10/22. INFORMATION IDENTIFIED: INDICATIONS, WARNINGS AND PRECAUTIONS. PER THE APPLICABLE IFU, IT IS STATED THAT REUSABLE SURGICAL INSTRUMENTS ARE SUSCEPTIBLE TO DAMAGE AND WEAR AND SHOULD BE INSPECTED AND CLEANED BEFORE EACH USE. THE NUMBER OF USES PER DRILL WILL VARY AND DEPENDS ON A VARIETY OF FACTORS INCLUDING BONE DENSITY ENCOUNTERED, PROPER HANDLING AND CLEANING. BASED ON THE INVESTIGATION AND RISK MANAGEMENT FILE REVIEW AS PER RMF RM-002W1 REV. 8, THE MOST LIKELY ROOT CAUSE DETERMINED FROM THE INVESTIGATION IS CUSTOMER ERROR (IMPROPER TECHNIQUES USED DURING PLACEMENT.) THEREFORE, BASED ON THE AVAILABLE INFORMATION, A DEVICE MALFUNCTION COULD NOT BE VERIFIED. WITHOUT DEVICE RECEIPT, THE REPORTED EVENT IS NON-VERIFIABLE. NO FURTHER INVESTIGATION OR IMMEDIATE CAPA / HHE/D ESCALATION IS REQUIRED, AS THE COMPLAINT INVESTIGATION DID NOT CONFIRM THE PRODUCT WAS 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. THE FOLLOWING SECTIONS HAVE BEEN UPDATED: B4: DATE OF THIS REPORT. G3: DATE RECEIVED BY MANUFACTURER. G6: CHECKED "FOLLOW-UP". H3: CHANGED "YES" TO "NO". H6: ENTERED EVALUATION CODES. H10: ADDED MANUFACTURER NARRATIVE H3 OTHER TEXT : DEVICE WAS NOT RETURNED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE TRANSPORTING IMPLANT TO PATIENT, IMPLANT DROPPED TO FLOOR. ASSISTANT STATED DOCTOR USED SAME WRENCH TO COMPLETE PROCEDURE BUT NOT SURE WHAT ITEM NUMBER IT IS.

    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
    1212190 DENTAL DRIVER NDP BIOMET 3I

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female