BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4.7 TAPERED SCREW VENT FM T

    MDR report key: 12351385 · Received August 20, 2021

    Report

    Report Number
    0002023141-2021-02259
    Event Type
    Malfunction
    Date Received
    August 20, 2021
    Report Date
    August 20, 2021
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    PMA / PMN Number
    K061410
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT. PLEASE SEE ASSOCIATED REPORT: 0002023141-2021-02258. ZIMMER BIOMET COMPLAINT NUMBER (B)(4). AGE AND DATE OF BIRTH UNKNOWN / NOT PROVIDED. WEIGHT UNKNOWN / NOT PROVIDED. CONCOMITANT MEDICAL PRODUCTS: TSVTWH13, IMP, TSV, 4.7, 13, MTXF, MG,HA-LOT# 1232543; THERAPY DATE UNKNOWN. CONCOMITANT MEDICAL PRODUCTS: URS2, UNIVERSAL RETAINING SCREW- LOT# UNKNOWN; THERAPY DATE UNKNOWN. NAME AND ADDRESS: LAST/GIVEN NAME UNKNOWN / NOT PROVIDED. ADDITIONAL PMA/510(K) NUMBER ¿ K011028/K013227. ONE MOUNT BUNDLED WITH TAPERED SCREW-VENT IMPLANT (TSVTWH13) AND ANOTHER FMT4 MOUNT WITH ASSOCIATED SCREWS WERE RETURNED FOR INVESTIGATION. VISUAL EVALUATION OF THE AS RETURNED PRODUCTS IDENTIFIED THAT THE MOUNT HEXES WERE FRACTURED BUT THE SCREWS WERE NOT. ONLY ONE MOUNT WAS REPORTED. ATTEMPTS WERE MADE TO CONTACT THE CUSTOMER FOR ADDITIONAL INFORMATION (ADDITIONAL ITEM AND EVENT CLARIFICATION) UNSUCCESSFULLY. THEREFORE, THE INVESTIGATION WAS CONDUCTED USING APPLICABLE RISK FILES, IFU AND OTHER AVAILABLE INFORMATION. BASED ON THE AVAILABLE INFORMATION, DEVICE MALFUNCTION DID OCCUR WITH THE REPORTED MOUNT. HOWEVER, THE REPORTED EVENT WAS UNCONFIRMED SINCE THE MOUNT SCREW WAS NOT FRACTURED. ADDITIONALLY, AN UNREPORTED MALFUNCTION WAS IDENTIFIED WITH THE ADDITIONAL MOUNT AS ITS HEX WAS FRACTURED. HOWEVER, THERE IS NO EXISTING NONCONFORMANCE / CAPA / HHE/D / IE / PRODUCT HOLD AGAINST THE REPORTED/RETURNED DEVICES THAT DID OR COULD CAUSE OR CONTRIBUTE TO THE REPORTED EVENT. MONTHLY POST MARKET TRENDING REVIEW IDENTIFIED NO ADVERSE TRENDS OR ACTIONABLE TRENDS FOR THE REPORTED EVENT OR DEVICES. ZIMMER BIOMET QUALITY MANAGEMENT SYSTEM (QMS) HAS CONTROLS IN PLACE TO ENSURE THE DISTRIBUTION OF CONFORMING PRODUCTS. THEREFORE, BASED ON THE AVAILABLE INFORMATION, THE PRODUCTS WERE WITHIN SPECIFICATIONS AND CONFORMING WHEN THEY LEFT ZIMMER BIOMET. DHR REVIEW FOR THE LOT (1232543) HAD REVEALED NO DEVIATIONS NOR NON-CONFORMANCES WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. HOWEVER, DHR COULD NOT BE REVIEWED FOR THE ADDITIONAL MOUNT SINCE THE LOT NUMBER WAS UNKNOWN. COMPLAINT HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT NUMBER (1232543) FOR SIMILAR EVENTS (COMPLAINT CATEGORY KEYWORDS: FRACTURE: SCREW) AND NO OTHER COMPLAINT WAS IDENTIFIED. HOWEVER, COMPLAINT HISTORY COULD NOT BE REVIEWED FOR THE ADDITIONAL MOUNT. FUNCTIONAL TESTING COULD NOT BE PERFORMED DUE TO THE NATURE OF THE DEVICES AND EVENT. THEREFORE, THE REPORTED EVENT COULD NOT BE RECREATED. THE COMPLAINT IS RELATED TO THE FUNCTIONAL PERFORMANCE OF THE DEVICES. A DEFINITIVE ROOT CAUSE COULD NOT BE IDENTIFIED. HOWEVER, THE POTENTIAL CAUSES ARE NOT APPLICABLE TO THIS INVESTIGATION. ALTHOUGH DIFFERENT/UNREPORTED MALFUNCTION HAS BEEN IDENTIFIED WITH THE RETURNED PRODUCTS, THE REPORTED EVENT (SCREW FRACTURE) HAS BEEN UNCONFIRMED FOLLOWING VISUAL EVALUATION. NO FURTHER INVESTIGATION OR IMMEDIATE CAPA / HHE/D ESCALATION IS REQUIRED, AS THE COMPLAINT INVESTIGATION DID NOT CONFIRM THE PRODUCTS WERE NONCONFORMING AT THE TIME OF DISTRIBUTION, AND NO NEW FAILURE MODE, HARM, OR HAZARDOUS SITUATION WAS IDENTIFIED THROUGH THE INVESTIGATION PERFORMED.

    Description of Event or Problem · 1

    DURING PRODUCT INSPECTION, AN ADDITIONAL FRACTURED MOUNT WAS IDENTIFIED (RETURNED). ATTEMPTS WERE MADE TO CONTACT THE CUSTOMER FOR ADDITIONAL INFORMATION (ADDITIONAL ITEM AND EVENT CLARIFICATION) UNSUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1245335 4.7 TAPERED SCREW VENT FM T DENTAL MOUNT DZE ZIMMER DENTAL

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR