BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORIS PST MAKO OFFSET SHELL IMPACTOR

    MDR report key: 5745833 · Received June 23, 2016

    Report

    Report Number
    3005985723-2016-00192
    Event Type
    Malfunction
    Date Received
    June 23, 2016
    Date of Event
    June 2, 2016
    Report Date
    November 13, 2017
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    PMA / PMN Number
    K121064
    Removal / Correction Number
    3005985723-2-26-2016-1-R
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    FOLLOW UP# 2 IS BEING SUBMITTED TO CORRECT THE CATALOG NUMBER AND LOT NUMBER. NOTIFIED OF ERROR ON 10/25/2017.

    Additional Manufacturer Narrative · 1

    BASED ON THE RESULTS OF INVESTIGATION. REPORTED EVENT: A SIZE 58 PST CUP CAME OFF OF THE 212260 IMPACTOR DURING IMPACTION. THE IMPACTOR WAS ATTEMPTED TO BE USED TO REMOVE THE CUP AND THE THREADS WERE DAMAGED. THE ISSUE RESULTED IN A 45 MINUTE DELAY. DEVICE EVALUATION AND RESULTS: VISUAL INSPECTION SHOWS DAMAGE TO THE THREADS OF THE IMPACTOR. THIS DAMAGE PREVENTS THE THREADS FROM MAINTAINING A PROPER THREAD FORM. DIMENSIONAL INSPECTION WAS NOT COMPLETED AS THE DEVICE SHOWED DAMAGE AND COULD NOT COMPLETE A FUNCTIONAL CHECK. FUNCTIONAL INSPECTION SHOWS THE DAMAGE TO THE THREADS PREVENTS THE IMPACTOR FROM MATING PROPERLY TO THE IMPLANT CUP. THE IMPACTOR CANNOT BE USED FOR INSERTING AN IMPLANT INTO THE ACETABULUM. REVIEW OF THE DEVICE HISTORY RECORDS INDICATE (B)(4) DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK ON (B)(6) 2016. NO NON-CONFORMANCES WERE IDENTIFIED DURING INSPECTION. A REVIEW OF COMPLAINTS IN CATSWEB AND TRACKWISE RELATED TO P/N 212260, LOT NUMBER 32982 SHOWS NO ADDITIONAL COMPLAINTS RELATED TO THE FAILURE IN THIS INVESTIGATION. TRACKING OF COMPLAINTS RELATED TO THE PART NUMBER 212260 WILL BE TRACKED THROUGH QUARTERLY TREND REQUEST #(B)(4). CONCLUSIONS: THE DAMAGE OF THE THREADS ON THE IMPACTOR WAS A RESULT OR ASSEMBLY ISSUES WITH THE CUP WHILE TRYING TO REMOVE THE CUP FROM THE ACETABULUM. NO ADDITIONAL INVESTIGATION IS REQUIRED. CORRECTIVE ACTION/PREVENTIVE ACTION: NO ACTION IS REQUIRED AT THIS TIME AS THERE IS NO INDICATION TO SUGGEST A PRODUCT NON-CONFORMITY OR UNANTICIPATED HAZARD.

    Description of Event or Problem · 1

    A SURGEON WAS PERFORMING A MAKOPLASTY TOTAL HIP ARTHROPLASTY USING THE ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM (RIO). IT WAS REPORTED THAT WHILE IMPACTING THE CUP, THREADS ON A CUP CAME OFF. THE SURGEON USED THE SHELL IMPACTOR TO RECOVER THE CUP AND THREADS GOT DAMAGED. THERE WAS NO HARM TO THE PATIENT. THE CASE WAS COMPLETED SUCCESSFULLY WITH A 45 MIN DELAY.

    Description of Event or Problem · 1

    A SURGEON WAS PERFORMING A MAKOPLASTY TOTAL HIP ARTHROPLASTY USING THE ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM (RIO). IT WAS REPORTED THAT WHILE IMPACTING THE CUP, THREADS ON A CUP CAME OFF. THE SURGEON USED THE SHELL IMPACTOR TO RECOVER THE CUP AND THREADS GOT DAMAGED. THERE WAS NO HARM TO THE PATIENT. THE CASE WAS COMPLETED SUCCESSFULLY WITH A 45 MIN DELAY.

    Description of Event or Problem · 1

    A SURGEON WAS PERFORMING A MAKOPLASTY TOTAL HIP ARTHROPLASTY USING THE ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM (RIO). IT WAS REPORTED THAT WHILE IMPACTING THE CUP, THREADS ON A CUP CAME OFF. THE SURGEON USED THE SHELL IMPACTOR TO RECOVER THE CUP AND THREADS GOT DAMAGED. THERE WAS NO HARM TO THE PATIENT. THE CASE WAS COMPLETED SUCCESSFULLY WITH A 45 MIN DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    398629 RESTORIS PST MAKO OFFSET SHELL IMPACTOR STEREOTACTIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP. 32982

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Other