BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BONE PIN, 3.2MM X 80MM, STERILE 2 PACK

    MDR report key: 5909355 · Received August 26, 2016

    Report

    Report Number
    3005985723-2016-00266
    Event Type
    Injury
    Date Received
    August 26, 2016
    Date of Event
    August 2, 2016
    Report Date
    August 10, 2016
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    PMA / PMN Number
    K142530
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NURSE

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    REPORTED EVENT: DURING LEFT MEDICAL UNI-COMPARTMENT KNEE ARTHROPLASTY, MAKO PLASTY, THE TIP OF THE TRACKER PIN BROKE OFF LEAVING A LITTLE OVER 1 CM OF THE PIN IN THE TIBIA. PROCEDURE WAS SUCCESSFULLY COMPLETED. NO REPORTED DELAY IN SURGERY. NO ADVERSE CONSEQUENCE TO THE PATIENT. PRODUCTS NOT AVAILABLE AS THEY WERE DISCARDED. DEVICE EVALUATION AND RESULTS: VISUAL INSPECTION WAS NOT PERFORMED AS THE DEVICE WAS NOT RETURNED FOR EVALUATION. DIMENSION INSPECTION COMPLETED AT THE TIME OF MANUFACTURING SHOWS THE LOT WAS WITHIN SPECIFICATION. DEVICE HISTORY REVIEW: REVIEW OF THE DEVICE HISTORY RECORDS (SEE ATTACHMENT 1) FOR THE ASSOCIATED LOT INDICATED (B)(4) DEVICES (143000-01 NON-STERILE BONE PIN, SINGLE) WERE MANUFACTURED SHIPPED TO (B)(4) ON SEPTEMBER 16, 2015 AND ACCEPTED INTO FINAL STOCK ON SEPTEMBER 16, 2015 PER ERP. COMPLAINT HISTORY REVIEW: A REVIEW OF COMPLAINTS IN (B)(6) RELATED TO P/N 143080, LOT NUMBER W42547-2 SHOWS NO OTHER COMPLAINTS RELATED TO THE FAILURE IN THIS INVESTIGATION. TRACKING OF COMPLAINTS RELATED TO THE 143080 PART NUMBER WILL BE TRACKED THROUGH QUARTERLY TREND REQUEST #789. CONCLUSIONS: AS PART OF THE INVESTIGATION INTO THIS COMPLAINT, THE ORIGINAL COMPLAINANT THAT WAS PRESENT FOR THE CASE WAS NOT ABLE TO BE REACHED. IT CAN ONLY BE ASSUMED THAT THE SURGEON DID USE THE DRILL GUIDE DURING PLACEMENT OF THE BONE PIN. THE BONE PIN BROKE AND BENT RELATED TO ANOTHER ONE OF THE OTHER POTENTIAL CAUSES FOUND IN 2.0 AFMEA 0007 SYS R35 INCLUDING: EXCESSIVE OFF-AXIS FORCE APPLIED, HIGH PATIENT BONE DENSITY, BONE PIN REUSE FATIGUE, BONE PIN RE-DIRECTED DURING INSERTION, IMPROPER DRILL SPEED USED INCREASING TORQUE ON PIN. BASED ON THIS INVESTIGATION, IT IS NOT POSSIBLE TO DETERMINE WHICH OF THE CAUSE(S) ABOVE CONTRIBUTED TO THE FAILURE. 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. DEVICE WAS NOT RETURNED FO EVALUATION.

    Description of Event or Problem · 1

    THE SURGEON PERFORMED A PARTIAL KNEE ARTHROPLASTY PROCEDURE USING THE ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM (RIO). DURING THE CASE, THE TIP OF THE BONE PIN BROKE OFF IN THE PATIENT'S TIBIA. THE SURGEON DECIDED TO LEAVE THE TIP OF THE BONE PIN IN THE PATIENT'S TIBIA. THE OUTCOME OF THE CASE WAS SUCCESSFUL.

    Description of Event or Problem · 1

    THE SURGEON PERFORMED A PARTIAL KNEE ARTHROPLASTY PROCEDURE USING THE ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM (RIO). DURING THE CASE, THE TIP OF THE BONE PIN BROKE OFF IN THE PATIENT'S TIBIA. THE SURGEON DECIDED TO LEAVE THE TIP OF THE BONE PIN IN THE PATIENT'S TIBIA. THE OUTCOME OF THE CASE WAS SUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    560369 BONE PIN, 3.2MM X 80MM, STERILE 2 PACK STEREOTAXIC DEVICE, ACCESSORY OLO MAKO SURGICAL CORP. W42547-2

    Patients

    Seq Age Sex Outcome Treatment
    1 Other