BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENCODER, J6, HIP 190-00137

    MDR report key: 7888753 · Received September 19, 2018

    Report

    Report Number
    3005985723-2018-00535
    Event Type
    Malfunction
    Date Received
    September 19, 2018
    Date of Event
    August 14, 2018
    Report Date
    January 2, 2019
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED EVENT: "THE MAKO ROBOTIC ARM FAILED DURING SURGERY, JOINT ERROR HAPPENED HALF WAY WHEN BURRING THE FEMORAL SIDE. AFTER SURGERY WE FOUND THE P/N 203486 J6 GLASS IS LOOSE AND THE SYSTEM J6 CANNOT HOMING." DEVICE EVALUATION AND RESULTS: PER (B)(4) - J6 ARM SUBASSEMBLY REPLACEMENT FOR J6 HOMING ISSUE PERFORMED PER SERVICE MANUAL. PRODUCT HISTORY REVIEW: A REVIEW OF DEVICE HISTORY RECORDS SHOWS THAT ON 01/31/12 1 DEVICE WAS INSPECTED AND 1 DEVICE WAS PLACED ON: NPR 12-02-0004, NPR 12-02-0016, NPR 12-02-0017, NPR 12-02-0043/0049/0050, NPR 12-02-0061. A REVIEW OF THE DATA REVEALED THAT THE NON-CONFORMANCES ARE NOT RELATED TO THE FAILURE ALLEGED IN THIS COMPLIANT. COMPLAINT HISTORY REVIEW: A REVIEW OF COMPLAINTS IN CATSWEB AND TRACKWISE RELATED TO P/N 203486 SHOWS 1 ADDITIONAL COMPLAINTS RELATED TO THE FAILURE IN THIS INVESTIGATION. THESE COMPLAINTS ARE: (B)(4). CONCLUSIONS: SYSTEM READY FOR CLINICAL USE. 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 · 0

    THE MAKO ROBOTIC ARM FAILED DURING SURGERY, JOINT ERROR HAPPENED HALF WAY WHEN BURRING THE FEMORAL SIDE. AFTER SURGERY WE FOUND THE P/N 203486 J6 GLASS IS LOOSE AND THE SYSTEM J6 CANNOT HOMING. REPAIR: THE J6 ARM SUBASSEMBLY(207557) REPLACED AND ALL TESTING WAS COMPLETED , SURGICAL DELAY >30 MINS. DESC : J6 ARM FOR HIP WITH QD. P/N: 207557. NEW :20755736. OLD :183271-2.

    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 MAKO ROBOTIC ARM FAILED DURING SURGERY, JOINT ERROR HAPPENED HALF WAY WHEN BURRING THE FEMORAL SIDE. AFTER SURGERY WE FOUND THE P/N 203486 J6 GLASS IS LOOSE AND THE SYSTEM J6 CANNOT HOMING. REPAIR: THE J6 ARM SUBASSEMBLY (207557) REPLACED AND ALL TESTING WAS COMPLETED, SURGICAL DELAY: 30 MINS. DESC: J6 ARM FOR HIP WITH QD, P/N: 207557, NEW: (B)(4), OLD: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    730022 ENCODER, J6, HIP 190-00137 STEREOTAXIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization