BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DENTAL DRIVER

    MDR report key: 18254311 · Received December 4, 2023

    Report

    Report Number
    0002023141-2023-03483
    Event Type
    Malfunction
    Date Received
    December 4, 2023
    Date of Event
    November 2, 2023
    Report Date
    May 28, 2024
    Manufacturer
    ZIMMER DENTAL
    Product Code
    NDP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4). THE FOLLOWING FIELDS HAVE BEEN UPDATED: B4: DATE OF THIS REPORT B5: DESCRIBE EVENT OR PROBLEM D1: BRAND NAME UPDATED D3: MANUFACTURER EMAIL ADDRESS D4: ADDITIONAL DEVICE INFORMATION D9: DEVICE AVAILABILITY G1: CONTACT OFFICE (AND MANUFACTURING SITE FOR DEVICES) CONTACT NAME AND EMAIL G3: DATE RECEIVED BY MANUFACTURER G6: TYPE OF REPORT H1: TYPE OF REPORTABLE EVENT H2: FOLLOW UP TYPE H3: DEVICE EVALUATED BY MANUFACTURER H4: DEVICE MANUFACTURER DATE H10: ADDITIONAL NARRATIVE ZIMVIE DID NOT RECEIVE ONE (1) UNKNOWN ZIMMER DRIVER 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 ZIMMER DRIVER 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, 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.

    Additional Manufacturer Narrative · 0

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4). D1: BRAND NAME UNKNOWN / NOT PROVIDED. D4: ADDITIONAL DEVICE INFORMATION UNKNOWN / NOT PROVIDED . D10. CONCOMITANT MEDICAL PRODUCTS TSVB11, IMPL TAPERED SCR-V MTX 3.7MM 3.5MM 11.5MM LOT 1270394. G4: PREMARKET IDENTIFICATION UNKNOWN / NOT PROVIDED . H4: DEVICE MANUFACTURER DATE UNKNOWN / NOT PROVIDED.

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING THE IMPLANT PLACEMENT, THE IMPLANT DISENGAGED FROM THE DRIVER AND FELL TO THE GROUND. TOOTH SITE 45, PROCEDURE COMPLETED WITH OTHER IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1036002 DENTAL DRIVER NDP ZIMMER DENTAL

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Male DENTAL IMPLANT SEE H10 NARRATIVE