BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLAMP ASSEMBLY, 3-PIN

    MDR report key: 6200846 · Received December 22, 2016

    Report

    Report Number
    3005985723-2016-00451
    Event Type
    Malfunction
    Date Received
    December 22, 2016
    Date of Event
    December 20, 2016
    Report Date
    February 6, 2017
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    PMA / PMN Number
    K141989
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REPORTED EVENT: THE REPORTED DEVICE WAS CONFIRMED TO BE A CLAMP ASSEMBLY- 3-PIN, CATALOG: 112390 LOT# 201443031402 WHICH HAD A BROKEN SCREW FROM A PELVIC ARRAY ADAPTOR IN IT. DEVICE EVALUATION AND RESULTS: VISUAL INSPECTION: VISUAL INSPECTION SHOWS THAT THE THREADED PORTION OF THE SCREW FROM THE 112240 PELVIC ARRAY ADAPTOR ASSEMBLY HAD BROKEN OFF AND WAS LODGED IN THE FEMALE THREAD OF THE 112390 CLAMP. DIMENSIONAL INSPECTION: DIMENSIONAL INSPECTION WAS NOT COMPLETED AS THE VISUAL INSPECTION CLEARLY SHOWS THE FAILURE OF THE ASSOCIATED DEVICE. FUNCTIONAL INSPECTION: WITH THE 112240 ADAPTOR SCREW BROKEN IN THE CLAMP, BOTH COMPONENTS ARE UNUSABLE. DEVICE HISTORY REVIEW: A REVIEW OF THE DEVICE HISTORY SHOWS THAT FOLLOWING RECEIPT AND INSPECTION ON: ON 3/5/14 (B)(4) PARTS WERE ACCEPTED, 1 PART WAS REJECTED FOR COSMETIC ISSUES. ON 6/30/14 (B)(4) WERE ACCEPTED WITH NO FAILURES. ON 9/16/14 (B)(4) PARTS WERE REJECTED ON NPR 14-09-0037 FOR INCOMPLETE DATA FOR THE THREAD MENTIONED IN THIS COMPLAINT. THE DATA WAS RECEIVED AND THE PARTS ACCEPTED ON 11/24/14. ON 9/16/14 (B)(4) PARTS WERE REJECTED ON NPR 14-09-0035 FOR INCOMPLETE DATA FOR THE THREAD MENTIONED IN THIS COMPLAINT. THE DATA WAS RECEIVED AND THE PARTS ACCEPTED ON 11/24/14. COMPLAINT HISTORY REVIEW: A REVIEW OF THE TRACKWISE AND CATSWEB DATABASES SHOWS NO SIMILAR COMPLAINTS RELATED TO P/N 112390, LOT# 201443031402. CONCLUSIONS: THE REPORT OF A BROKEN 112240 PELVIC ARRAY ADAPTOR WAS CONFIRMED. THE SCREW FROM THE ADAPTOR WAS LODGED IN THE 112390 CLAMP WHICH IS THE SUBJECT OF THIS COMPLAINT. THE ISSUE OCCURRED DURING A CASE BUT DID NOT AFFECT THE PATIENT AND THE CASE WAS SUCCESSFUL. CORRECTIVE ACTION/PREVENTIVE ACTION: NO FURTHER ACTION IS REQUIRED.

    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 SURGEON WAS COMPLETING A TOTAL HIP ARTHROPLASTY PROCEDURE USING THE ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM (RIO). AS THE DOCTOR WAS TIGHTENING THE PELVIC ARRAY WITH THE SQUARE DRIVER, THE APADATER BROKE OFF.

    Description of Event or Problem · 1

    THE SURGEON WAS COMPLETING A TOTAL HIP ARTHROPLASTY PROCEDURE USING THE ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM (RIO). AS THE DOCTOR WAS TIGHTENING THE PELVIC ARRAY WITH THE SQUARE DRIVER, THE APADATER BROKE OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    850661 CLAMP ASSEMBLY, 3-PIN STEREOTACTIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP. 201443031402

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization