BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN ZIMMER HEX DRIVER

    MDR report key: 8429795 · Received March 18, 2019

    Report

    Report Number
    0001038806-2019-00220
    Event Type
    Malfunction
    Date Received
    March 18, 2019
    Date of Event
    January 29, 2019
    Report Date
    June 5, 2019
    Manufacturer
    ZIMMER DENTAL
    Product Code
    NDP
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS ARE BEING REPORTED: B5: IT WAS REPORTED THAT THE IMPLANT WAS DROPPED AT TOOTH LOCATION #19 DUE TO THE HEX DRIVER NOT INTEGRATING. THE DRIVER WOULD NOT HOLD THE IMPLANT. ANOTHER IMPLANT WAS NOT PLACED. IT IS REPORTED THAT THE DEVICES DID NOT HAVE ANY PATIENT INTERACTION. E2: YES. G4: 03 JUNE 2019. G7: FOLLOW UP. H1: MALFUNCTION. H2: ADDITIONAL INFORMATION, DEVICE EVALUATION. H3: YES, EVALUATION SUMMARY ATTACHED. H6: METHOD, RESULTS, CONCLUSION. H10: MANUFACTURER NARRATIVE. THE REPORTED HEX DRIVER DEVICE WAS NOT RECEIVED FOR EVALUATION. THE REPORTED EVENT OF THE HEX DRIVER NOT INTEGRATING COULD NOT BE CONFIRMED. THE CONCOMITANT IMPLANT AND MOUNT WERE RECEIVED. THE IMPLANT/MOUNT SUCCESSFULLY ENGAGED WITH AN IN-HOUSE HEX DRIVER DURING FUNCTIONAL TESTING. A DEVICE HISTORY RECORD (DHR) REVIEW COULD NOT BE PERFORMED AS THE REPORTED DEVICE LOT IS UNKNOWN. A COMPLAINT HISTORY REVIEW FOR THE REPORTED DEVICE COULD NOT BE PERFORMED AS THE DEVICE LOT IS UNKNOWN. A DEFINITIVE ROOT CAUSE FOR THE REPORTED EVENT COULD NOT BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS. DEVICE NOT RETURNED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE IMPLANT WAS DROPPED AT TOOTH LOCATION #19 DUE TO THE HEX DRIVER NOT INTEGRATING. THE DRIVER WOULD NOT HOLD THE IMPLANT. ANOTHER IMPLANT WAS NOT PLACED. IT IS REPORTED THAT THE DEVICES DID NOT HAVE ANY PATIENT INTERACTION.

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING SUBMITTED TO REPORT ZIMMER BIOMET COMPLAINT (B)(4). CONCOMITANT MEDICAL PRODUCTS: ZIMMER TAPERED SCREW VENT IMPLANT; ITEM#: TSVT6B11, LOT#: 1220674. THE FOLLOWING INFORMATION IS UNKNOWN AT THE TIME OF THIS REPORT: DEVICE PRODUCT CODE UNKNOWN. MANUFACTURE DATE: UNKNOWN. THE REPORTED DEVICE WAS NOT RECEIVED FOR INVESTIGATION. AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS. CONCOMITANT DEVICE RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IMPLANT WAS DROPPED AT TOOTH LOCATION #19 DUE TO THE HEX DRIVER NOT INTEGRATING. THE DRIVER WOULD NOT HOLD THE IMPLANT. ANOTHER IMPLANT WAS NOT PLACED. IT IS REPORTED THAT THE DEVICES DID NOT HAVE ANY PATIENT INTERACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    220611 UNKNOWN ZIMMER HEX DRIVER HEX DRIVER NDP ZIMMER DENTAL N/A UNKNKOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR SEE H10 NARRATIVE