BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORIS PST MAKO OFFSET SHELL IMPACTOR

    MDR report key: 7131001 · Received December 19, 2017

    Report

    Report Number
    3005985723-2017-00627
    Event Type
    Malfunction
    Date Received
    December 19, 2017
    Date of Event
    December 12, 2017
    Report Date
    May 30, 2018
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    PMA / PMN Number
    K170593
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    FOLLOW-UP #1 AND FINAL REPORT SUBMITTED TO UPDATE. REPORTED EVENT: IT WAS REPORTED THAT THE SHELL IMPACTOR WAS DAMAGED DURING THE CASE. PRODUCT EVALUATION AND RESULTS: NO DEVICE INSPECTION COULD BE COMPLETED AS THE PRODUCT WAS NOT AVAILABLE FOR EVALUATION. NC 1694916 HAS BEEN INITIATED IN REGARDS TO MISSING PRODUCT. PRODUCT HISTORY REVIEW: REVIEW OF THE PRODUCT HISTORY RECORDS INDICATE 11 DEVICES WERE MANUFACTURED UNDER LOT NO 32991 AND 10 ACCEPTED INTO FINAL STOCK ON 07/26/2016. REVIEW OF QT16-07-0070 REVEALED THAT THE NON CONFORMANCE IS NOT RELATED TO THE FAILURE ALLEGED IN THIS COMPLAINT. COMPLAINT HISTORY REVIEW: A REVIEW OF COMPLAINTS IN CATSWEB AND TRACKWISE RELATED TO P/N 212260, LOT NUMBER 32991 SHOWS NO ADDITIONAL COMPLAINTS RELATED TO THE FAILURE IN THIS INVESTIGATION. CONCLUSIONS: THE FAILURE MODE COULD NOT BE CONFIRMED BECAUSE THE PART WAS NOT AVAILABLE FOR EVALUATION. IF DEVICE AND/OR ADDITIONAL INFORMATION BECOME AVAILABLE, THIS INVESTIGATION WILL BE REOPENED. 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. DEVICE NOT RETURNED.

    Description of Event or Problem · 0

    ON (B)(6) 2017 DURING A TOTAL HIP PROCEDURE DR. (B)(6) WAS ATTEMPTING TO REMOVE THE CUP AFTER INITIAL IMPACTION. WHILE DR. (B)(6) WAS ATTEMPTING TO REMOVE THE PST CUP AND REPOSTION IT ,THE THREADS OF THE PST CUP BROKE OFF AND THE IMPACTION HANDLE CAME UNATTACHED FROM THE CUP. THE THREADS ON THE IMPACTION HANDLE WERE ALSO DAMAGED, AND A PST CUP CAN NO LONGER EASILY SCREW ONTO THE END OF THE IMPACTION HANDLE. THE DAMAGE TO THE IMPACTION HANDLE WAS NOTICED WHEN HE SCRUB TECH ATTEMPTED TO SCREW A NEW CUP ONTO THE IMPACTION HANDLE.

    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

    ON (B)(6) 2017 DURING A TOTAL HIP PROCEDURE DR. (B)(6) WAS ATTEMPTING TO REMOVE THE CUP AFTER INITIAL IMPACTION. WHILE DR. (B)(6) WAS ATTEMPTING TO REMOVE THE PST CUP AND REPOSITION IT ,THE THREADS OF THE PST CUP BROKE OFF AND THE IMPACTION HANDLE CAME UNATTACHED FROM THE CUP. THE THREADS ON THE IMPACTION HANDLE WERE ALSO DAMAGED, AND A PST CUP CAN NO LONGER EASILY SCREW ONTO THE END OF THE IMPACTION HANDLE. THE DAMAGE TO THE IMPACTION HANDLE WAS NOTICED WHEN HE SCRUB TECH ATTEMPTED TO SCREW A NEW CUP ONTO THE IMPACTION HANDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    907945 RESTORIS PST MAKO OFFSET SHELL IMPACTOR STEREOTAXIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP. 32991

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization