BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HANDPIECE MICS

    MDR report key: 8639991 · Received May 24, 2019

    Report

    Report Number
    3005985723-2019-00384
    Event Type
    Malfunction
    Date Received
    May 24, 2019
    Date of Event
    May 13, 2019
    Report Date
    July 17, 2019
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    UDI-DI
    00848486030193
    PMA / PMN Number
    K142530
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    FOLLOW-UP #1 AND FINAL REPORT SUBMITTED TO UPDATE SECTIONS D.3, G.1, G.4, G.7, H.2, H.3, H.6, H.10 AND H.11 BASED ON THE RESULTS OF INVESTIGATION. REPORTED EVENT: DURING RESECTION OF THE TIBIA, THE INTERNAL HOUSING THAT HOLDS THE SAGITTAL SAW ATTACHMENT TO THE HAND PIECE BROKE. THE BOLTS CAME UNTHREADED AND THE ATTACHMENT AND HOUSING FELL TO THE FLOOR, RENDERING THE HANDPIECE BROKEN. PRODUCT EVALUATION AND RESULTS: VISUAL INSPECTION: VISUAL INSPECTION WAS PERFORMED AND CONFIRMED THAT THE COLLAR WAS BROKEN. FUNCTIONAL INSPECTION, DIMENSIONAL INSPECTION AND MATERIAL ANALYSIS WERE NOT PERFORMED AS VISUAL INSPECTION CONFIRMED THE FAILURE. PER (B)(4) AND (B)(4). PRODUCT WAS RTV FOR REWORK. PRODUCT HISTORY REVIEW: DEVICE HISTORY RECORDS INDICATE 25 DEVICES WERE MANUFACTURED UNDER LOT K0670 AND 23 INCLUDING 4200278 WERE ACCEPTED INTO FINAL STOCK ON 10/24/2015. A REVIEW OF QT15-10-0069 AND QT15-10-0070 REVEALED THAT THE ISSUES ARE NOT RELATED TO THE FAILURE ALLEGED IN THIS COMPLIANT. COMPLAINT HISTORY REVIEW: A REVIEW OF COMPLAINTS RELATED TO P/N 209063, PRODEX LOT K0670 SHOWS NO ADDITIONAL COMPLAINT(S) RELATED TO THE FAILURE IN THIS INVESTIGATION. CONCLUSIONS: THE ALLEGED FAILURE MODE WAS CONFIRMED. NO ADDITIONAL INVESTIGATION OR SPECIFIC ACTIONS ARE REQUIRED. CORRECTIVE ACTION/PREVENTIVE ACTION: A REVIEW OF STRYKER¿S NC/CAPA DATABASE INDICATED THAT NC 1414517 AND CAPA 1450904 ARE ASSOCIATED WITH THE FAILURE MODE REPORTED IN THIS EVENT.

    Description of Event or Problem · 0

    DURING RESECTION OF THE TIBIA, THE INTERNAL HOUSING THAT HOLDS THE SAGITTAL SAW ATTACHMENT TO THE HAND PIECE BROKE. THE BOLTS CAME UNTHREADED AND THE ATTACHMENT AND HOUSING FELL TO THE FLOOR, RENDERING THE HANDPIECE BROKEN. CASE TYPE: TKA. SURGICAL DELAY: =15 MINUTES.

    Additional Manufacturer Narrative · 1

    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 WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    DURING RESECTION OF THE TIBIA, THE INTERNAL HOUSING THAT HOLDS THE SAGITTAL SAW ATTACHMENT TO THE HAND PIECE BROKE. THE BOLTS CAME UNTHREADED AND THE ATTACHMENT AND HOUSING FELL TO THE FLOOR, RENDERING THE HANDPIECE BROKEN. CASE TYPE: TKA. SURGICAL DELAY: = 15 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    434242 HANDPIECE MICS STEREOTAXIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP. 42021015 / 4200262 00848486030193

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization