BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VALIDATION TOOL

    MDR report key: 6015401 · Received October 10, 2016

    Report

    Report Number
    0009617840-2016-00042
    Event Type
    Malfunction
    Date Received
    October 10, 2016
    Date of Event
    September 12, 2016
    Report Date
    September 12, 2016
    Manufacturer
    ZIMMER CAS
    Product Code
    OLO
    PMA / PMN Number
    PK141601
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    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 COULD NOT BE COMPLETED WITH THE LIMITED INFORMATION PROVIDED. MANUFACTURE DATE ¿ NI.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. METHOD: EXAMINATION OF RETURNED DEVICE FOUND NO EVIDENCE OF PRODUCT NON-CONFORMANCE. THE FRACTURED DRIVE PIN WAS NOT RETURNED WITH THE INSTRUMENT; VISUAL INSPECTION FOUND THE REMAINING PIN HAD NO BENDING OR DAMAGE. A CONCLUSIVE ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER WARNINGS, "DO NOT APPLY EXCESSIVE FORCE TO THE INSTRUMENTS AS THIS MAY CAUSE DEFORMATION OR BREAKAGE."

    Description of Event or Problem · 1

    DURING A RIGHT KNEE ARTHROPLASTY PROCEDURE, A PIN FRACTURED OFF THE VALIDATION TOOL AS IT WAS BEING IMPACTED. NO FRACTURED PIECES WERE RETAINED BY THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    665031 VALIDATION TOOL ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO ZIMMER CAS N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR