BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BONE PIN, 3.2MM X 140MM, STERILE 2 PACK

    MDR report key: 6184997 · Received December 19, 2016

    Report

    Report Number
    3005985723-2016-00441
    Event Type
    Injury
    Date Received
    December 19, 2016
    Date of Event
    December 16, 2016
    Report Date
    February 15, 2017
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    PMA / PMN Number
    K142530
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    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: BROKE 2 MAKO PINS DURING SURGERY. UNABLE TO RETRIEVE PIECES OF PINS. 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 (B)(4) DEVICES (143140 NON-STERILE BONE PIN, SINGLE) WERE MANUFACTURED SHIPPED TO (B)(4) ON 06/21/2016 AND ACCEPTED INTO FINAL STOCK ON 06/21/2016 PER ERP. COMPLAINT HISTORY REVIEW: A REVIEW OF COMPLAINTS IN (B)(6) RELATED TO P/N 143140, LOT NUMBER W46871 SHOWS TWO ADDITIONAL COMPLAINTS RELATED TO THE FAILURE IN THIS INVESTIGATION, (B)(4). TRACKING OF COMPLAINTS RELATED TO THE 143140 PART NUMBER WILL BE TRACKED THROUGH QUARTERLY TREND REQUEST #789. CONCLUSIONS: THE MPS WAS UNABLE TO CONFIRM THE USE OF THE ARRAY STABILIZERS 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. THE DEVICE WAS NOT RETURNED.

    Description of Event or Problem · 1

    THE SURGEON WAS COMPLETING A PARTIAL KNEE ARTHROPLASTY PROCEDURE USING THE ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM (RIO), WHEN 2 MAKO PINS BROKE DURING THE SURGERY. THE PIECES OF THE PINS WAS UNRETRIEVABLE.

    Description of Event or Problem · 1

    THE SURGEON WAS COMPLETING A PARTIAL KNEE ARTHROPLASTY PROCEDURE USING THE ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM (RIO), WHEN 2 MAKO PINS BROKE DURING THE SURGERY. THE PIECES OF THE PINS WAS UNRETRIEVABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    835383 BONE PIN, 3.2MM X 140MM, STERILE 2 PACK STEREOTACTIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP. W46871

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other