BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERNAL CONNECTION UNIVERSAL PLACEMENT DRIVER TIP - SHORT

    MDR report key: 9948241 · Received April 10, 2020

    Report

    Report Number
    0001038806-2020-00665
    Event Type
    Malfunction
    Date Received
    April 10, 2020
    Report Date
    June 17, 2020
    Manufacturer
    BIOMET 3I
    Product Code
    NDP
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ONE INTERNAL CONNECTION UNIVERSAL PLACEMENT DRIVER TIP - SHORT (IIPDTUS) WAS RETURNED FOR INVESTIGATION. VISUAL EVALUATION OF THE AS RETURNED PRODUCT IDENTIFIED SIGNS OF USE AND NO APPARENT MALFUNCTION. FUNCTIONAL TESTING WAS PERFORMED FOR THE RETURNED PRODUCT AND IT WAS DETERMINED THE DEVICE PASSED FUNCTIONAL TESTING AS THE DRIVER ASSEMBLED, RETAINED AND DISENGAGED AS INTENDED WITH AN INHOUSE IMPLANT. NO PER WAS PROVIDED. NO PRE-EXISTING CONDITIONS WERE NOTED. THE PATIENT HAD UNKNOWN BONE DENSITY. THE REPORTED DEVICES WAS USED ON AN UNKNOWN TOOTH AND WERE USED FOR AN UNKNOWN DURATION. PICTURES WERE NOT PROVIDED. DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER (1231073). 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 (1231073) FOR SIMILAR EVENTS AND NO OTHER COMPLAINT WAS IDENTIFIED. APRIL POST MARKET TRENDING WAS REVIEWED AND THERE WERE NO ACTIONABLE EVENTS OR CORRECTIVE ACTIONS FOR THE REPORTED EVENT (DOES NOT DISENGAGE/RELEASE) OR PRODUCTS (IIPDTUS). THEREFORE, BASED ON THE AVAILABLE INFORMATION, DEVICE MALFUNCTION DID NOT OCCUR FOR THE IIPDTUS AND THE REPORTED EVENT WAS NON-VERIFIABLE. A DEFINITIVE ROOT CAUSE COULD NOT BE IDENTIFIED. HOWEVER, BASED ON THE INVESTIGATION AND RISK FILE REVIEW, THE MOST LIKELY CAUSE DETERMINED FROM THE INVESTIGATION IS THE CLINICIAN DOES NOT FOLLOW THE RECOMMENDED GUIDANCE FOR USAGE IN SURGICAL MANUAL.

    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). AGE: NOT PROVIDED. PATIENT WEIGHT: NOT PROVIDED. EVENT DATE: NOT PROVIDED. INITIAL REPORTER FAX NUMBER: NOT PROVIDED. DEVICE WAS NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PROCEDURE, THE DRIVER (IIPDTUS) GOT STUCK IN THE IMPLANT. THE DRIVER MISSED FIT AND CAUSED SURGICAL PROBLEMS. NO SERIOUS INJURY HAS BEEN REPORTED ASSOCIATED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    413610 INTERNAL CONNECTION UNIVERSAL PLACEMENT DRIVER TIP - SHORT UNIVERSAL PLACEMENT DRIVER. NDP BIOMET 3I 1231073

    Patients

    Seq Age Sex Outcome Treatment
    1