BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 5969067 · Received September 21, 2016

    Report

    Report Number
    3005985723-2016-00299
    Event Type
    Injury
    Date Received
    September 21, 2016
    Date of Event
    September 13, 2016
    Report Date
    September 13, 2016
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    PMA / PMN Number
    K142530
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1 AND FINAL REPORT SUBMITTED TO UPDATE MFR CONTACT INFO,, MANUFACTURER SITE, DATE RECEIVED BY MFR, TYPE OF REPORTS, IF FOLLOW-UP,WHAT TYPE?, DEVICE EVALUATED BY MFR?, EVALUATION CODES, ADDITIONAL MFR NARRATIVE BASED ON THE RESULTS OF INVESTIGATION. REPORTED EVENT: PART NUMBER 143140 LOT NUMBER W46868, PART NUMBER 143140 LOT NUMBER W43263, PART NUMBER 143080 LOT NUMBER W44720, ROB 377, TWO DIFFERENT 3.2 MM X 140MM BONE PINS AND ONE 3.2 MM X 80MM BONE PIN BROKE OFF IN PATIENT'S LEG TODAY. DEVICE EVALUATION AND RESULTS: NOT PERFORMED AS THE DEVICE WAS NOT RETURNED FOR EVALUATION. DEVICE HISTORY REVIEW: REVIEW OF THE DEVICE HISTORY RECORDS FOR THE ASSOCIATED LOT INDICATED 2409 DEVICES (143000-01 NON-STERILE BONE PIN, SINGLE) WERE MANUFACTURED SHIPPED TO MILLSTONE ON MAY 16, 2016 AND ACCEPTED INTO FINAL STOCK ON MAY 16, 2016 PER ERP. COMPLAINT HISTORY REVIEW: A REVIEW OF COMPLAINTS IN CATSWEB AND TRACKWISE RELATED TO P/N 143080, LOT NUMBER W44720 SHOWS ONE ADDITIONAL COMPLAINT RELATED TO THE FAILURE IN THIS INVESTIGATION. THE RELATED PI IS (B)(4). TRACKING OF COMPLAINTS RELATED TO THE 143080 PART NUMBER WILL BE TRACKED THROUGH QUARTERLY TREND REQUEST #(B)(4). CONCLUSIONS: THE MPS CONFIRMED THE SURGEON DID NOT USE THE DRILL GUIDE TO INSERT THE BONE PINS. AS SUCH, THIS IS OFF LABEL USE. NO ACTION IS REQUIRED AT THIS TIME AS THERE IS NO INDICATION TO SUGGEST A PRODUCT NON-CONFORMITY OR UNANTICIPATED HAZARD. 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 NOT RETURNED FOR EVALUATION.

    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 PARTIAL KNEE ARTHROPLASTY PROCEDURE USING THE ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM (RIO). DURING THE CASE WHILE THE SURGEON WAS DRILLING A BONE PIN INTO THE PATIENT'S TIBIA, THE BONE PIN BROKE OFF INSIDE OF THE TIBIA. THE BONE PIN WAS LEFT INSIDE OF THE PATIENT AND THE OUTCOME OF THE CASE WAS SUCCESSFUL.

    Description of Event or Problem · 1

    A SURGEON WAS PERFORMING A PARTIAL KNEE ARTHROPLASTY PROCEDURE USING THE ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM (RIO). DURING THE CASE WHILE THE SURGEON WAS DRILLING A BONE PIN INTO THE PATIENT'S TIBIA, THE BONE PIN BROKE OFF INSIDE OF THE TIBIA. THE BONE PIN WAS LEFT INSIDE OF THE PATIENT AND THE OUTCOME OF THE CASE WAS SUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    618017 BONE PIN, 3.2MM X 80MM, STERILE 2 PACK STEREOTAXIC DEVICE, ACCESSORY OLO MAKO SURGICAL CORP. LOT NUMBER W44720

    Patients

    Seq Age Sex Outcome Treatment
    1 Other