BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.7 DEGREE STRAIGHT SAGITAL SAW

    MDR report key: 7965500 · Received October 15, 2018

    Report

    Report Number
    3005985723-2018-00588
    Event Type
    Malfunction
    Date Received
    October 15, 2018
    Date of Event
    October 9, 2018
    Report Date
    January 3, 2019
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    UDI-DI
    00848486032111
    PMA / PMN Number
    K143752
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED ISSUE: UPON DISASSEMBLY OF MICS AT END OF CASE THERE WAS A SMALL METAL SHAVING OF UNKNOWN SOURCE ON ATTACHMENT. CASE TYPE: TKA. PRODUCT HISTORY REVIEW: A REVIEW OF THE DEVICE HISTORY RECORDS INDICATE 50 DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK ON 09/16/17. NO NON-CONFORMANCES WERE IDENTIFIED DURING INSPECTION. COMPLAINT HISTORY REVIEW: A REVIEW OF COMPLAINTS RELATED TO P/N 212186, LOT NUMBER 35020817 SHOWS NO ADDITIONAL COMPLAINT(S) RELATED TO THE FAILURE IN THIS INVESTIGATION. TRACKING OF COMPLAINTS RELATED TO P/N 212186 WILL BE TRACKED THROUGH TREND REQUEST NUMBER (B)(4). VISUAL INSPECTION: VISUAL INSPECTION COULD NOT BE PERFORMED BECAUSE THE PRODUCT WAS NOT RETURNED. DIMENSIONAL INSPECTION: DIMENSIONAL INSPECTION COULD NOT BE PERFORMED BECAUSE THE PRODUCT WAS NOT RETURNED. MATERIAL ANALYSIS: MATERIAL ANALYSIS COULD NOT BE PERFORMED BECAUSE THE PRODUCT WAS NOT RETURNED. NC/CAPA HISTORY REVIEW: A REVIEW OF STRYKER¿S NC/CAPA DATABASE INDICATED THERE HAVE BEEN NO NCS OR CAPAS ASSOCIATED WITH THE PRODUCT AND FAILURE MODE REPORTED IN THIS EVENT. CONCLUSION: THE FAILURE MODE COULD NOT BE CONFIRMED BECAUSE THE PART WAS NOT RETURNED. IF DEVICE AND/OR ADDITIONAL INFORMATION BECOME AVAILABLE, THIS INVESTIGATION WILL BE REOPENED. DEVICE NOT RETURNED.

    Description of Event or Problem · 0

    UPON DISASSEMBLY OF MICS AT END OF CASE THERE WAS A SMALL METAL SHAVING OF UNKNOWN SOURCE ON ATTACHMENT. CASE TYPE: TKA.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    UPON DISASSEMBLY OF MICS AT END OF CASE THERE WAS A SMALL METAL SHAVING OF UNKNOWN SOURCE ON ATTACHMENT. CASE TYPE: TKA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    806430 2.7 DEGREE STRAIGHT SAGITAL SAW STEREOTAXIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP. 35020817 00848486032111

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization