BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHELL IMPACTION PLATFORM

    MDR report key: 8319716 · Received February 8, 2019

    Report

    Report Number
    3005985723-2019-00119
    Event Type
    Malfunction
    Date Received
    February 8, 2019
    Date of Event
    February 5, 2019
    Report Date
    May 7, 2019
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    UDI-DI
    00848486022082
    PMA / PMN Number
    K121064
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT IDENTIFICATION: THE RETURNED DEVICE WAS CONFIRMED TO BE A TRIDENT INLINE OFFSET IMPACTOR, P/N 209830, L/N 32953, RM 267706. INSPECTION: VISUAL INSPECTION SHOWED THE DEVICE'S SHAFT BROKEN WHERE THE IMPACTION PLATFORM ASSEMBLES. PRODUCT HISTORY: REVIEW OF DEVICE HISTORY RECORDS SHOWS THE FOLLOWING NUMBER OF DEVICES ON THEIR GIVEN DATES WERE ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES: 35 ON (B)(6) 2016, 24 OF 25 ON (B)(6) 2016, 37 ON (B)(6) 2016, 2 ON (B)(6) 2016, 2 ON (B)(6) 2016. THE ONE REJECTED DEVICE WAS DISPOSITIONED PER (B)(4) FOR AN OUT OF SPEC FEATURE UNRELATED TO THE FAILURE IN THIS INVESTIGATION. COMPLAINT HISTORY REVIEW: REVIEW OF COMPLAINTS WITHIN THE TRACKWISE DATABASE FOR P/N 209830, L/N 32953 SHOWS ZERO (0) COMPLAINTS RELATED TO THE FAILURE IN THIS INVESTIGATION. 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. CONCLUSION: FUNCTIONAL INSPECTION CONFIRMS ALLEGED FAILURE OF A BROKEN DEVICE.

    Description of Event or Problem · 0

    WHILE IMPACTING CUP ON THE FINAL STRIKE, THE END STRIKE PLATE FOR THE OFFSET IMPACTOR BROKE INTO PIECES. CASE TYPE: THA.

    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

    WHILE IMPACTING CUP ON THE FINAL STRIKE, THE END STRIKE PLATE FOR THE OFFSET IMPACTOR BROKE INTO PIECES. CASE TYPE: THA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    112445 SHELL IMPACTION PLATFORM STEREOTAXIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP. 45011215 00848486022082

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization