BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOOL HANDLE SST SQUARE CONNECTION

    MDR report key: 12193312 · Received July 19, 2021

    Report

    Report Number
    0002023141-2021-01854
    Event Type
    Malfunction
    Date Received
    July 19, 2021
    Date of Event
    June 24, 2021
    Report Date
    November 12, 2021
    Manufacturer
    ZIMMER DENTAL
    Product Code
    NDP
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ONE IMPL TAPERED SCR-V HA 3.7 MM 3.5MM 11.5MM (TSVH11) AND TOOL HANDLE SST SQUARE CONNECTION (SSHS) WERE RETURNED FOR INVESTIGATION. VISUAL INSPECTION OF THE AS RETURNED PRODUCT IDENTIFIED SIGNS OF WEAR ABOUT THE TOOL HANDLE AND DRIVE FEATURE. THE IMPLANT AND MOUNT SHOW MINIMAL SIGNS OF WEAR. FUNCTIONAL TESTING OF THE DEVICES NOTES THAT THE TWO COMPONENTS DISENGAGE WHEN ASSEMBLED. FURTHER TESTING NOTES THAT THE IMPLANT IS STILL ABLE TO ENGAGE WITH SIMILAR TOOLS, WHILE THE SSHS NO LONGER ASSEMBLES WITH ANY COMPONENTS. NO PRE-EXISTING CONDITIONS WERE NOTED ON THE PER. THE REPORTED IMPLANT WAS LOCATED ON AN UNKNOWN TOOTH SITE AND REMOVED THE DAY OF PLACEMENT. THE CUSTOMER HAS NOT PROVIDED ADDITIONAL PICTURES OR X-RAY IMAGES OF THE PRODUCT. APPROPRIATE DOCUMENTATION WAS REVIEWED. (TSVH11): DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER 1240057. IT WAS CONFIRMED THAT ALL OPERATIONS AND INSPECTIONS WERE EXECUTED AS PER APPLICABLE PROCEDURE. NO DEVIATIONS OR NON-CONFORMANCES, WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT WAS NOTED AS PART OF THE DHR. LOT WAS INSPECTED AND PASSED ALL ACCEPTANCE CRITERIA BY QA. (SSHS): DHR REVIEW COULD NOT BE PERFORMED, AS THE LOT NUMBER ASSOCIATED WITH THE REPORTED PRODUCT IS NOT AVAILABLE. ZIMMER BIOMET QUALITY MANAGEMENT SYSTEM (QMS) HAS CONTROLS IN PLACE TO ENSURE THE DISTRIBUTION OF CONFORMING PRODUCT WITHIN SPECIFICATIONS. (TSVH11): COMPLAINT HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT NUMBER (1240057) FOR SIMILAR EVENT AND NO OTHER COMPLAINT WAS IDENTIFIED. (SSHS): A COMPLAINT HISTORY REVIEW BY ITEM NUMBER WAS CONDUCTED FOR THE SSHS DATING BACK TO 12 MONTHS FROM NOW. THE COMPLAINT HISTORY REVIEW REVEALED THAT THERE ARE NO EXISTING NON-CONFORMANCES/CAPA/HHE/D/IE/PRODUCT HOLDS FOR THE REPORTED PRODUCT. BASED ON THE AVAILABLE INFORMATION, DEVICE MALFUNCTION HAS OCCURRED AND THE REPORTED EVENT WAS CONFIRMED FOR THE RETURNED SSHS. THE RETURNED IMPLANT FUNCTIONED AS INTENDED WHEN TESTED INDIVIDUALLY. THE FOLLOWING SECTIONS HAVE BEEN UPDATED: B4: DATE OF THIS REPORT G3: DATE RECEIVED BY MANUFACTURER G6: CHECKED "FOLLOW-UP" H2: CHECKED FOLLOW-UP TYPE H3: CHANGED "NO" TO "YES" H6: ENTERED EVALUATION CODES H10: ADDED MANUFACTURER NARRATIVE

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DR. WAS TRYING TO PLACE A TSVH11 LOT 1240057 WHEN THE IMPLANT FELL OUT OF THE SSHS DRIVER HANDLE. DR. IS LOOKING FOR A REPLACEMENT IMPLANT. TOOTH LOCATION NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1083934 TOOL HANDLE SST SQUARE CONNECTION DENTAL IMPLANT NDP ZIMMER DENTAL

    Patients

    Seq Age Sex Outcome Treatment
    1 Prefer Not To Disclose