BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REAMER HANDLE OFFSET

    MDR report key: 20642336 · Received November 8, 2024

    Report

    Report Number
    3005985723-2024-00236
    Event Type
    Malfunction
    Date Received
    November 8, 2024
    Date of Event
    October 18, 2024
    Report Date
    December 19, 2024
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    PMA / PMN Number
    K170593
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    AN EVENT REGARDING MISSING COMPONENT INVOLVING A MAKO REAMER HANDLE WAS REPORTED. THE EVENT WAS NOT CONFIRMED BECAUSE THE PRODUCT WAS NOT AVAILABLE FOR INSPECTION. METHOD & RESULTS: PRODUCT EVALUATION AND RESULTS: MATERIAL ANALYSIS, VISUAL, FUNCTIONAL AND DIMENSIONAL INSPECTIONS COULD NOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED. CLINICIAN REVIEW: NO MEDICAL RECORDS WERE RECEIVED FOR REVIEW WITH A CLINICAL CONSULTANT. PRODUCT HISTORY REVIEW: A PRODUCT HISTORY REVIEW IS NOT REQUIRED, AS NO MANUFACTURING SPECIFIC ISSUE HAS BEEN ALLEGED. COMPLAINT HISTORY REVIEW: A COMPLAINT HISTORY REVIEW AND TREND DETECTION IS NOT REQUIRED AS THIS IS A PM. CONCLUSIONS: NO PATIENT WAS INVOLVED AND NO ACTUAL OR POTENTIAL PATIENT HARM EXISTED FOR THE ALLEGED EVENT. THE ALLEGED FAILURE MODE WAS NOT CONFIRMED BECAUSE THE PRODUCT WAS NOT AVAILABLE FOR INSPECTION. NO ADDITIONAL INVESTIGATION OR SPECIFIC ACTIONS ARE REQUIRED. IF ADDITIONAL INFORMATION IS RECEIVED THEN THE COMPLAINT WILL BE REOPENED.

    Additional Manufacturer Narrative · 0

    AS PART OF NORMAL COMPLAINT FOLLOW-UP, AN EVALUATION OF THE EVENT HAS BEEN INITIATED BY MAKO SURGICAL. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    OFFSET REAMER HANDLE MISSING SCREW CASE TYPE / APPLICATION: NO ASSOCIATED PROCEDURE - (IF APPLICABLE) WILL DEVICE BE DECONTAMINATED? DEVICE(S) DO NOT NEED TO BE DECONTAMINATED (NO PATIENT CONTACT/ BIOBURDEN).

    Description of Event or Problem · 0

    OFFSET REAMER HANDLE MISSING SCREW. CASE TYPE / APPLICATION: NO ASSOCIATED PROCEDURE (IF APPLICABLE) WILL DEVICE BE DECONTAMINATED? DEVICE(S) DO NOT NEED TO BE DECONTAMINATED (NO PATIENT CONTACT/ BIOBURDEN).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1880244 REAMER HANDLE OFFSET ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO MAKO SURGICAL CORP. 5472914

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other