BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPL TAPERED SCR-V SBM 4. 7MM 4.5MM 11.5MM

    MDR report key: 10838824 · Received November 13, 2020

    Report

    Report Number
    0002023141-2020-01990
    Event Type
    Malfunction
    Date Received
    November 13, 2020
    Date of Event
    October 20, 2020
    Report Date
    March 8, 2021
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    PMA / PMN Number
    K061410
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ONE IMPL TAPERED SCR-V SBM 4. 7MM 4.5MM 11.5MM (TSVWB11) PACKAGING WAS RETURNED FOR INVESTIGATION. VISUAL EVALUATION OF THE AS RETURNED PRODUCT PACKAGING IDENTIFIED THE OUTER BOX, OUTER VIAL, TRACEABILITY LABELS AND IFU. THE OUTER VIAL SEAL BROKEN WITHOUT ANY INNER VIAL, IMPLANT, MOUNT, OR SCREW. FUNCTIONAL TESTING TO RECREATE THE REPORTED EVENT COULD NOT BE PERFORMED DUE TO THE NATURE OF THE DEVICE & EVENT. PRE-EXISTING PATIENT FACTORS AND TOOTH LOCATION ARE NOT RELEVANT TO THE REPORTED EVENT. THE DEVICE WAS REPORTED DURING INITIAL USE IN THE PROCEDURE. CMP- 0639976 AND CMP-0639977 ARE LINKED AS THEY WERE REPORTED TOGETHER BY THE SAME CUSTOMER FOR SIMILAR EVENTS ON SEPARATE DATES. THESE EVENTS WILL BE INVESTIGATED SEPARATELY. THE CUSTOMER PROVIDED PICTURES OF THE REPORTED DEVICES FOR BOTH COMPLAINTS, SHOWING THE OUTER BOXES AND OUTER VIALS. IN THE IMAGES, ONE OUTER VIAL SEAL IS VISIBLY BROKEN WHILE THE OTHER ONE CANNOT BE DETERMINED DUE TO THE HANDS OBSTRUCTING THE VIEW OF THE VIAL SEAL. HOWEVER, EVALUATION OF THE RETURNED DEVICES DETERMINED BOTH OUTER VIAL SEALS WERE BROKEN. THE CONDITIONS OF THE REPORTED PRODUCT WHEN IT FIRST REACHED THE CUSTOMER ARE UNKNOWN. DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER (1232450). 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, WERE NOTED AS PART OF THE DHR. LOT WAS INSPECTED AND PASSED ALL ACCEPTANCE CRITERIA BY QA. COMPLAINT HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT NUMBER (1232450) FOR SIMILAR EVENTS AND NO OTHER COMPLAINTS WERE IDENTIFIED. DECEMBER POST MARKET TRENDING WAS REVIEWED AND THERE WERE NO ACTIONABLE EVENTS OR CORRECTIVE ACTIONS FOR THE REPORTED EVENT (PACKAGING : INCORRECT COMPONENT QUANTITY) OR DEVICE (TSVWB11). THEREFORE, BASED ON THE AVAILABLE INFORMATION, THE PACKAGING MALFUNCTION COULD NOT BE VERIFIED AND THE REPORTED EVENT WAS NON-VERIFIABLE AS THE CONDITIONS OF THE PRODUCT WHEN IT FIRST REACHED THE CUSTOMER ARE UNKNOWN. A DEFINITIVE ROOT CAUSE COULD NOT BE IDENTIFIED. HOWEVER, THE ABOVE PROBABLE CAUSES ARE NOT APPLICABLE SINCE DHR REVIEW DETERMINED THE PRODUCT PACKAGING WAS CONFORMING WHEN IT LEFT ZIMMER BIOMET CONTROL. THEREFORE, THE MOST APPLICABLE PROBABLE CAUSES ARE RELATED TO USER ERROR AND HANDLING AFTER DISTRIBUTION. 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.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET COMPLAINT (B)(4). AGE: NOT PROVIDED. PATIENT WEIGHT: NOT PROVIDED. INITIAL REPORTER EMAIL ADDRESS, FAX NUMBER: NOT PROVIDED. ADDITIONAL PMA/510(K) NUMBER: K013227.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CLINICAL PROCEDURE, NO IMPLANT, MOUNT OR SCREW WERE FOUND IN THE IMPLANT PACKAGING. PROCEDURE WAS COMPLETED USING ANOTHER IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1305106 IMPL TAPERED SCR-V SBM 4. 7MM 4.5MM 11.5MM DENTAL IMPLANT DZE ZIMMER DENTAL 1232450

    Patients

    Seq Age Sex Outcome Treatment
    1