BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRINITY HIP OFFSET CUP IMPACTOR (CG)

    MDR report key: 5174105 · Received October 24, 2015

    Report

    Report Number
    3005985723-2015-00214
    Event Type
    Malfunction
    Date Received
    October 24, 2015
    Date of Event
    July 27, 2015
    Report Date
    July 27, 2015
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    PMA / PMN Number
    K121064
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REPORTED EVENT: THE EVENT REPORTED THAT THE OFFSET CUP REMOVAL KNOB OF THE IMPACTOR BROKE OFF DURING IMPACTION. THE PROCEDURE WAS SUCCESSFUL AND THERE WAS NO HARM OR DELAY DURING CASE. DEVICE EVALUATION AND RESULTS: VISUAL INSPECTION SHOWS A BROKEN / SHEARED OFFSET CUP REMOVAL KNOB (P/N 205415) FROM ITS CONNECTION JOINT TO THE 2.X HIP CONNECTOR SHAFT (P/N 207068). DIMENSIONAL INSPECTION WAS NOT PERFORMED AS THE VISUAL INSPECTION CLEARLY SHOWS THE FAILURE. FUNCTIONAL INSPECTION WAS NOT PERFORMED AS THE VISUAL INSPECTION CLEARLY SHOWS THE FAILURE. DEVICE HISTORY REVIEW: REVIEW OF THE DEVICE HISTORY RECORDS INDICATE THE FOLLOWING FOR P/N 207077, L/N 06100612: - ZERO (0) PARTS ACCEPTED AND 16 REJECTED ON 06/30/2012 FOR FAI. REVIEW OF ASSOCIATED NPR 12-06-0108 REVEALED THAT THE NONCONFORMANCES ARE NOT RELATED TO THE FAILURE ALLEGED IN THIS COMPLAINT. - (B)(4) DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK ON 07/12/2012. - ONE (1) DEVICE WAS MANUFACTURED AND ACCEPTED INTO FINAL STOCK ON 07/19/2012. COMPLAINT HISTORY REVIEW: A REVIEW OF COMPLAINTS WITHIN CATSWEB AND TRACKWISE DATABASES RELATED TO P/N 207077, L/N 06100612 SHOWS ZERO NUMBER OF COMPLAINTS RELATED TO THE FAILURE IN THIS INVESTIGATION. TRACKING OF COMPLAINTS RELATED TO THE 207077 PART NUMBER WILL BE TRACKED THROUGH QUARTERLY TREND REQUEST #767. CONCLUSIONS: THE FAILURE OF A BROKEN OFFSET CUP REMOVAL KNOB WAS CONFIRMED. VISUAL INSPECTION SHOWED A BROKEN / SHEARED OFFSET CUP REMOVAL KNOB (P/N 205415) FROM ITS CONNECTION JOINT TO THE 2.X HIP CONNECTOR SHAFT (P/N 207068).

    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

    A SURGEON WAS PERFORMING A MAKOPLASTY TOTAL HIP ARTHROPLASTY USING THE ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM (RIO). DURING THE CASE, THE KNOW TO THE THREAD CUP BROKE OFF. THIS DID NOT NEGATIVELY IMPACT THE CASE, THE OUTCOME WAS SUCCESSFUL, AND THERE WAS NO HARM TO THE PATIENT.

    Description of Event or Problem · 1

    A SURGEON WAS PERFORMING A MAKOPLASTY TOTAL HIP ARTHROPLASTY USING THE ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM (RIO). DURING THE CASE, THE KNOW TO THE THREAD CUP BROKE OFF. THIS DID NOT NEGATIVELY IMPACT THE CASE, THE OUTCOME WAS SUCCESSFUL, AND THERE WAS NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    704540 TRINITY HIP OFFSET CUP IMPACTOR (CG) STEREOTACTIC DEVICE, INSTRUMENT OLO MAKO SURGICAL CORP. LOT #06100612

    Patients

    Seq Age Sex Outcome Treatment
    1 Other