BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMP,TSV,4.7,11.5,MTX,MG

    MDR report key: 13308799 · Received January 20, 2022

    Report

    Report Number
    0002023141-2022-00127
    Event Type
    Malfunction
    Date Received
    January 20, 2022
    Report Date
    July 19, 2022
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024020009
    PMA / PMN Number
    K101977
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    DENTIST
    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. PATIENT SEX UNKNOWN / NOT PROVIDED. WEIGHT UNKNOWN / NOT PROVIDED. DATE OF EVENT UNKNOWN / NOT PROVIDED. FAX NUMBER UNKNOWN / NOT PROVIDED. ADDITIONAL PMA/510(K) NUMBER ¿ K013227. CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED TO RELAY CORRECTED DATA, ADDITIONAL INFORMATION AND DEVICE EVALUATION. CORRECTED DATA: D1: BRAND NAME WAS UPDATED TO IMP,TSV,4.7,11.5,MTX,MG D4: ITEM NUMBER WAS UPDATED TO TSVTWB11 G4: PMA/510(K) NUMBER WAS UPDATED TO K101977 G4: ADDITIONAL PMA/510(K) NUMBER WAS UPDATED TO K101880 THE FOLLOWING SECTIONS ARE BEING REPORTED: B4: DATE OF THIS REPORT WAS UPDATED. D9: DEVICE AVAILABILITY AND RETURN DATE WAS UPDATED. G3: DATE RECEIVED BY MANUFACTURER WAS UPDATED. G6: TYPE OF REPORT WAS UPDATED. H2: TYPE OF FOLLOW UP WAS UPDATED. H3: DEVICE EVALUATED BY MANUFACTURER WAS UPDATED. H6: TYPE OF INVESTIGATION CODES WERE ADDED: 4109, 4111 AND 3331. H6: INVESTIGATION FINDINGS CODE WAS ADDED: 213. H6: INVESTIGATION CONCLUSIONS CODE WAS ADDED: 67. H10: NARRATIVE/DATA WAS UPDATED. ONE EMPTY ALREADY OPEN OUTER PACKAGING / VIAL FOR AN IMPL TAPERED SCR-V SBM 4. 7MM 4.5MM 11.5MM (TSVTWB11) WAS RETURNED FOR INVESTIGATION. VISUAL EVALUATION OF THE AS RETURNED PRODUCT IDENTIFIED THE OUTER BOX, IMPLANT PACKAGING OPENED AND INNER VIAL HAS BROKEN TAMPER SEAL. PACKAGING ALSO INCLUDED TRACEABILITY LABELS AND IFU. NO IMPLANT RETURNED. THE REPORTED EVENT IS NON-VERIFIABLE WITH THE INFORMATION PROVIDED. AS THE PACKAGING WAS ALREADY OPENED, THE CIRCUMSTANCES OF DEVICE DELIVERY COULD NOT BE RECREATED. BASED ON THE EVALUATION, DEVICE MALFUNCTION COULD NOT BE VERIFIED. HOWEVER, THERE IS NO EXISTING NONCONFORMANCE/CAPA/HHE/D/IE/PRODUCT HOLDS AGAINST THE REPORTED PRODUCT THAT DID OR COULD CAUSE OR CONTRIBUTE TO THE REPORTED EVENT. ZIMMER BIOMET QUALITY MANAGEMENT SYSTEM (QMS) HAS CONTROLS IN PLACE TO ENSURE THE DISTRIBUTION OF CONFORMING PRODUCT. THEREFORE, BASED ON THE AVAILABLE INFORMATION, THE PRODUCT WAS LIKELY WITHIN SPECIFICATION AND LIKELY CONFORMING WHEN IT LEFT ZIMMER BIOMET. DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER (1250209). 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. UPON REVIEW OF THE DHR, PACKAGING IMAGES FURTHER VERIFY THE CONFORMANCE OF THE PACKAGING FOR THE REPORTED DEVICE. COMPLAINT HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT NUMBER (1250209) FOR SIMILAR EVENT USING KEYWORD (INCORRECT COMPONENT QUANTITY) AND NO OTHER COMPLAINT WAS IDENTIFIED. THE REPORTED EVENT COULD NOT BE RECREATED DUE TO THE NATURE OF THE DENTAL DEVICE AND EVENT (MISSING COMPONENTS) AND THE COMPLAINT IS NOT RELATED TO THE FUNCTIONAL PERFORMANCE OF THE PRODUCT. THE MOST LIKELY CAUSE OF THE EVENT IS HANDLING OF THE PACKAGING, AS THE MENTIONED RISKS ARE ASSOCIATED WITH THE PACKAGING PROCESS, AND REVIEW OF THE PRODUCT FINAL INSPECTION REVEALED THAT ALL INSPECTED PRODUCT PASSED INSPECTION. 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

    IT WAS REPORTED THAT THE DOCTOR ATTEMPTED TO USED AN IMPLANT DURING A PLACEMENT PROCEDURE AND THE BOX WAS EMPTY. THE DOCTOR USED A DIFFERENT SIZE IMPLANT TO COMPLETE THE PROCEDURE. NO PATIENT IMPACT.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION RECEIVED AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    520946 IMP,TSV,4.7,11.5,MTX,MG DENTAL IMPLANT DZE ZIMMER DENTAL TSVTWB11 1250209 00889024020009

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown