BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DENTAL DRIVER

    MDR report key: 14653377 · Received June 10, 2022

    Report

    Report Number
    0002023141-2022-01465
    Event Type
    Malfunction
    Date Received
    June 10, 2022
    Date of Event
    May 14, 2022
    Report Date
    November 15, 2022
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMMER BIOMET COMPLAINT NUMBER: (B)(4). PATIENT IDENTIFIER UNKNOWN / NOT PROVIDED. AGE AND DATE OF BIRTH UNKNOWN / NOT PROVIDED. WEIGHT UNKNOWN / NOT PROVIDED. DATE OF EVENT UNKNOWN / NOT PROVIDED. BRAND NAME UNKNOWN / NOT PROVIDED. DEVICE PRODUCT CODE UNKNOWN / NOT PROVIDED. ADDITIONAL DEVICE INFORMATION UNKNOWN. PMA/510(K) NUMBER NOT AVAILABLE.

    Additional Manufacturer Narrative · 0

    ZIMMERBIOMET COMPLAINT NUMBER (B)(4). UNKNOWN ZIMMER DRIVER WAS REPORTED FOR PRODUCT DISENGAGED; HOWEVER, THE PRODUCT WAS NOT RETURNED FOR INVESTIGATION, SO VISUAL EVALUATION COULD NOT BE PERFORMED. ADDITIONALLY, FUNCTIONAL TESTING TO RECREATE THE REPORTED EVENT COULD NOT BE PERFORMED DUE TO THE NATURE OF THE DEVICES & EVENT. PRE-EXISTING PATIENT FACTORS, X-RAY, AND TOOTH LOCATION ARE NOT RELEVANT TO THE REPORTED EVENT. THE LENGTH OF THE DRIVER'S USAGE IS UNKNOWN. THE CUSTOMER DID NOT PROVIDE ANY PICTURES. REVIEW OF APPROPRIATE DOCUMENTATION: DOCUMENTS REVIEWED: INSTRUCTIONS FOR USE - TAPERED SCREW-VENT AND TRABECULAR METAL IMPLANTS, IFU4869 REV. 9-10/19. INSTRUCTIONS FOR USE - ZIMMER INSTRUMENT KIT SYSTEM, ZIMMER DENTAL SINGLE PATIENT DRILLS, DRIVA DRILLS, AND TOOLS, IFU 8874 REV 5 ¿ 08/19. INFORMATION IDENTIFIED: 'WARNINGS' 'PRECAUTIONS' 'STERILITY' 'POTENTIAL ADVERSE EVENTS' PER THE APPLICABLE IFU, IT IS STATED THAT IMPROPER TECHNIQUE CAN CAUSE DEVICE FAILURE. DHR REVIEW: DHR REVIEW AND COMPLAINT HISTORY REVIEW BY LOT NUMBER COULD NOT BE PERFORMED, AS THE LOT NUMBER ASSOCIATED WITH THE REPORTED PRODUCT (UNKNOWN ZIMMER DRIVER) IS NOT AVAILABLE. ZIMVIE QUALITY MANAGEMENT SYSTEM (QMS) HAS CONTROLS IN PLACE TO ENSURE THE DISTRIBUTION OF CONFORMING PRODUCT WITHIN SPECIFICATIONS. POST MARKET TRENDING REVIEW: SEPTEMBER POST MARKET TRENDING WAS REVIEWED AND THERE WERE NO ACTIONABLE EVENTS OR CORRECTIVE ACTIONS FOR THE REPORTED EVENT OR PRODUCT. NO ACTIONABLE ITEMS HAVE BEEN TRIGGERED THAT WILL AFFECT COMPLAINT HANDLING ON OUR END FOR THIS MONTH. BASED ON THE AVAILABLE INFORMATION, MALFUNCTION COULD NOT BE VERIFIED. THEREFORE, THE REPORTED EVENT WAS NON-VERIFIABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING THE TRANSFER OF THE IMPLANT FROM THE PACKAGING TO SURGICAL SITE, IMPLANT FELL OUT FORM THE DRIVER. PROCEDURE WAS COMPLETED USING ANOTHER IMPLANT WHICH THEY HAD ON THIERS STOCK.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2157696 DENTAL DRIVER DZE ZIMMER DENTAL

    Patients

    Seq Age Sex Outcome Treatment
    1 Female