BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HANDPIECE MICS

    MDR report key: 18746875 · Received February 21, 2024

    Report

    Report Number
    3005985723-2024-00024
    Event Type
    Malfunction
    Date Received
    February 21, 2024
    Date of Event
    January 24, 2024
    Report Date
    June 3, 2024
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    UDI-DI
    00848486030193
    PMA / PMN Number
    K172219
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    AS PART OF THE 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 INACCURATE RESECTION INVOLVING A MAKO MICS 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: REVIEW OF THE DEVICE HISTORY RECORDS INDICATE DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO RELEVANT REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW: THERE HAVE BEEN NO OTHER COMPLAINTS WITH SIMILAR EVENT(S) FOR THE LOT REFERENCED. CONCLUSIONS: 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.

    Description of Event or Problem · 0

    DURING A LEFT MAKO TKA, A GAP OF APPROX. 2MM BETWEEN THE TRIAL IMPLANT AND THE DISTAL CUT WAS NOTICED BY THE SURGEON. AT THIS POINT, THE ARRAYS WERE ALREADY REMOVED SO WE WERE UNABLE TO VERIFY THE CUTS. HANDPIECE TESTING RESULTS POST OP: 1) REG 0.3 VER 1.03 2) REG 0.31 VER 1.24 3) REG 0.30 VER 1.12.

    Description of Event or Problem · 0

    DURING A LEFT MAKO TKA, A GAP OF APPROX. 2MM BETWEEN THE TRIAL IMPLANT AND THE DISTAL CUT WAS NOTICED BY THE SURGEON. AT THIS POINT, THE ARRAYS WERE ALREADY REMOVED SO WE WERE UNABLE TO VERIFY THE CUTS. HANDPIECE TESTING RESULTS POST OP: 1) REG 0.3 VER 1.03. 2) REG 0.31 VER 1.24. 3) REG 0.30 VER 1.12. ADDITIONAL INFO. 18-APR.-2024: WHICH CUTS WERE INACCURATE? DISTAL CUT. HOW WAS THE CUT INACCURATE? (PROUD, DEEP, ETC) THE CUT WAS DEEP. WHAT WAS THE ESTIMATED DISCREPANCY? 2MM. WAS THE PLANAR PROBE UTILIZED TO MEASURE THE CUT ACCURACY? NO, AS THE ARRAYS HAD ALREADY BEEN REMOVED BY THE TIME THE DISCREPANCY WAS REALISED. WHAT DID THE SURGEON DO TO ADDRESS THE ISSUE? USED MORE CEMENT TO FILL THE GAP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1415364 HANDPIECE MICS ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO MAKO SURGICAL CORP. 42180422 / 4215904 00848486030193

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male Other