BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REAMER HANDLE OFFSET

    MDR report key: 19921199 · Received August 6, 2024

    Report

    Report Number
    3005985723-2024-00106
    Event Type
    Malfunction
    Date Received
    August 6, 2024
    Date of Event
    July 11, 2024
    Report Date
    September 26, 2024
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    UDI-DI
    00848486032142
    PMA / PMN Number
    K170593
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    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.

    Additional Manufacturer Narrative · 0

    AN EVENT REGARDING DISASSOCIATION 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. AT STRYKER JOINT REPLACEMENT ALL DEVICES/PRODUCT ARE MANUFACTURED THROUGH VALIDATED EQUIPMENT AND INSPECTED BY TRAINED REPRESENTATIVES THROUGH STRYKER¿S QUALITY MANAGEMENT SYSTEM. -COMPLAINT HISTORY REVIEW: A COMPLAINT HISTORY REVIEW AND TREND DETECTION IS NOT REQUIRED AS THIS IS A PM. MONITORING WILL BE CONTINUED UNDER THE CURRENT QUARTERLY TREND REVIEW. CONCLUSIONS: PREVENTIVE MAINTENANCE IS WHERE AN ACTION OCCURS THAT IDENTIFIES DEVICE DETERIORATION WHICH MAY COMPROMISE FUNCTION. UNDER PM CONDITIONS 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. CORRECTIVE ACTION/PREVENTIVE ACTION: NO ACTION IS REQUIRED AT THIS TIME AS THERE IS NO INDICATION TO SUGGEST A PRODUCT NONCONFORMITY OR UNANTICIPATED HAZARD.

    Description of Event or Problem · 0

    SCREW FELL OUT OF THE REAMER AS IT WAS TAKEN OUT OF THE TRAY 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

    SCREW FELL OUT OF THE REAMER AS IT WAS TAKEN OUT OF THE TRAY 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
    1673946 REAMER HANDLE OFFSET ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO MAKO SURGICAL CORP. 4731806 00848486032142

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other