BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VALIDATION TOOL

    MDR report key: 6185624 · Received December 19, 2016

    Report

    Report Number
    0009617840-2016-00045
    Event Type
    Injury
    Date Received
    December 19, 2016
    Date of Event
    November 29, 2016
    Report Date
    April 28, 2017
    Manufacturer
    ZIMMER CAS
    Product Code
    OLO
    PMA / PMN Number
    PK141601
    Removal / Correction Number
    ZFA 2017-23
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. INSPECTION OF THE PART CONFIRMS THAT ONE OF THE SPIKES HAS COMPLETELY DISASSEMBLE FROM THE VALIDATION TOOL BASE. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. INVESTIGATION RESULTS CONCLUDED THAT THE REPORTED EVENT WAS DUE TO THE IMPACTION FORCE TRANSMITTED IN THE DRIVE PIN HEAD DURING THE INSTALLATION OF THE VALIDATION TOOL. THIS DEVICE IS PART OF A RECALL PREVIOUSLY INITIATED TO ADDRESS THE REPORTED ISSUE. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 1

    THE PRODUCT IDENTIFICATION NECESSARY TO REVIEW MANUFACTURING HISTORY WAS NOT PROVIDED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. THE FOLLOWING SECTIONS COULD NOT BE COMPLETED WITH THE LIMITED INFORMATION PROVIDED.

    Description of Event or Problem · 1

    DURING A RIGHT TOTAL KNEE ARTHROPLASTY, A PIN FRACTURED AFTER IMPACTION. THE FRACTURED PIECE WAS REMOVED FROM THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    838540 VALIDATION TOOL ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO ZIMMER CAS N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention