BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RIO®SHELL IMPACT-OFFSET-TRIDENT PST

    MDR report key: 8200171 · Received December 27, 2018

    Report

    Report Number
    3005985723-2018-00786
    Event Type
    Malfunction
    Date Received
    December 27, 2018
    Date of Event
    November 30, 2018
    Report Date
    March 25, 2019
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    UDI-DI
    00848486030285
    PMA / PMN Number
    K141989
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED EVENT: IT WAS REPORTED THAT WHILE DR. (B)(6) WAS USING A MALLET TO IMPACT THE TRIDENT CUP INTO THE PATIENT THE IMPACTION PLATFORM PIECE CRACKED DOWN THE CENTER AND EVENTUALLY BROKE IN HALF ONCE WE REMOVED IT FROM THE INLINE-OFFSET IMPACTION HANDLE. PRODUCT EVALUATION AND RESULTS: PRODUCT INSPECTION COULD NOT BE PERFORMED AS THE PRODUCT WAS NOT AVAILABLE FOR EVALUATION. PRODUCT HISTORY REVIEW: REVIEW OF THE DEVICE HISTORY RECORDS INDICATE 88 DEVICES WERE MANUFACTURED UNDER LOT 33850. 26 DEVICES WERE ACCEPTED INTO FINAL STOCK ON 11/01/2016. 01 DEVICES WERE ACCEPTED INTO FINAL STOCK ON 11/30/2016. 60 DEVICES WERE ACCEPTED INTO FINAL STOCK ON 08/18/2016.REVIEW OF QT16 - 08 - 0065 REVEALED THAT THE NON-CONFORMANCE IS NOT RELATED TO THE FAILURE ALLEGED IN THIS COMPLIANT. COMPLAINT HISTORY REVIEW: A REVIEW OF COMPLAINTS RELATED TO P/N 209830, L/N 33850 SHOW NO ADDITIONAL COMPLAINT 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. PRODUCT WAS NOT AVAILABLE FOR EVALUATION.

    Description of Event or Problem · 0

    WHILE DR. (B)(6) WAS USING A MALLET TO IMPACT THE TRIDENT CUP INTO THE PATIENT THE IMPACTION PLATFORM PIECE CRACKED DOWN THE CENTER AND EVENTUALLY BROKE IN HALF ONCE WE REMOVED IT FROM THE INLINE-OFFSET IMPACTION HANDLE. 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 DR. (B)(6) WAS USING A MALLET TO IMPACT THE TRIDENT CUP INTO THE PATIENT THE IMPACTION PLATFORM PIECE CRACKED DOWN THE CENTER AND EVENTUAL BROKE IN HALF ONCE WE REMOVED IT FROM THE INLINE-OFFSET IMPACTION HANDLE. CASE TYPE: THA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1039676 RIO®SHELL IMPACT-OFFSET-TRIDENT PST STEREOTAXIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP. 33850 00848486030285

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization