BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HANDPIECE MICS

    MDR report key: 6452743 · Received April 3, 2017

    Report

    Report Number
    3005985723-2017-00159
    Event Type
    Malfunction
    Date Received
    April 3, 2017
    Date of Event
    March 22, 2017
    Report Date
    May 23, 2017
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    PMA / PMN Number
    K141989
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    "REPORTED EVENT: IT WAS REPORTED THAT THE MICS HAND PIECE WAS SUCCESSFULLY USED TO REAM THE ACETABULUM. WHEN THE REAMING FINISHED AND THE REAMER WAS OUT OF THE PATIENT THE MICS HANDLE AND THE PLASTIC PART OF THE HANDLE CAME OFF. ISSUE WAS NOTICED DURING CASE, THERE WAS NO CASE DELAY AND NO PATIENT HARM. DEVICE HISTORY REVIEW: REVIEW OF DEVICE HISTORY RECORDS INDICATE (B)(4) DEVICES WERE MANUFACTURED UNDER LOT K07V8 AND (B)(4) INCLUDING 4200849 WERE ACCEPTED INTO FINAL STOCK ON 7/21/16. COMPLAINT HISTORY REVIEW: A REVIEW OF COMPLAINTS RELATED TO PARTS IN LOT NUMBER K07V8, P/N 209063 SHOWS NO OTHER COMPLAINT RELATED TO THE FAILURE IN THIS INVESTIGATION." VISUAL INSPECTION: VISUAL INSPECTION REVEALED NO PHYSICAL DAMAGE OF UNIT. THE SCREW WAS OUTSIDE OF THE UNIT. DIMENSIONAL INSPECTION: DIMENSIONAL INSPECTION WAS NOT COMPLETED VISUAL INSPECTION CLEARLY SHOWS THE FAILURE OF THE DEVICE. FUNCTIONAL INSPECTION: FUNCTIONAL INSPECTION WAS NOT COMPLETED. REPORTED PROBLEM WAS WITH THE SCREW AND HANDLE. A REVIEW OF COMPLAINTS RELATED TO PARTS IN LOT NUMBER K07V8, P/N 209063 SHOWS NO OTHER COMPLAINT RELATED TO THE FAILURE IN THIS INVESTIGATION. ISSUES FOR P/N 209063 WILL BE TRACKED THROUGH TREND REQUEST #1025. CONCLUSIONS: THE SCREW HOLDS THE HANDLE IN PLACE. IF THE SCREW BACKS OUT THEN THE HANDLE CAN FALL. CORRECTIVE ACTION/PREVENTIVE ACTION: A REVIEW OF STRYKER¿S NC/CAPA DATABASE INDICATED THAT (B)(4) AND CAPA (B)(4) ARE ASSOCIATED WITH THE FAILURE MODE REPORTED IN THIS EVENT.

    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

    THE SURGEON WAS COMPLETING A TOTAL HIP ARTHROPLASTY PROCEDURE USING THE ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM. THE SURGEON USED THE MICS HAND PIECE TO SUCCESSFULLY REAM THE ACETABULUM. WHEN HE WAS FINISHED AND THE REAMER WAS OUT OF THE PATIENT HE LET GO OF THE MICS HANDLE AND THE PLASTIC PART OF THE HANDLE CAME OFF AS SOON AS HE LET IT GO.

    Description of Event or Problem · 1

    THE SURGEON WAS COMPLETING A TOTAL HIP ARTHROPLASTY PROCEDURE USING THE ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM. THE SURGEON USED THE MICS HAND PIECE TO SUCCESSFULLY REAM THE ACETABULUM. WHEN HE WAS FINISHED AND THE REAMER WAS OUT OF THE PATIENT HE LET GO OF THE MICS HANDLE AND THE PLASTIC PART OF THE HANDLE CAME OFF AS SOON AS HE LET IT GO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236426 HANDPIECE MICS STEREOTAXIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization