BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 5232956 · Received November 18, 2015

    Report

    Report Number
    3005985723-2015-00258
    Event Type
    Malfunction
    Date Received
    November 18, 2015
    Date of Event
    November 13, 2015
    Report Date
    November 13, 2015
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    PMA / PMN Number
    K112507
    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. REPORTED EVENT: 3.2 X 140 BONE PIN BROKE DURING SURGERY. IT BROKE OFF BELOW THE SURFACE OF THE BONE AND THE TIP WAS LEFT IN THE PATIENT'S BONE. THERE WAS NO DELAY TO THE CASE, NO ADVERSE AFFECTS TO PATIENT, AND CASE WAS SUCCESSFULLY FINISHED. 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: (B)(4). COMPLAINT HISTORY REVIEW: A REVIEW OF COMPLAINTS IN (B)(4) RELATED TO P/N 143140, LOT NUMBER W41380 (AND RELATED LOT NUMBERS W41380-1 AND W41380-2) SHOWS THREE COMPLAINTS RELATED TO THE FAILURE IN THIS INVESTIGATION. THE ASSOCIATED PR NUMBERS ARE (B)(4). TRACKING OF COMPLAINTS RELATED TO THE 1143140 PART NUMBER WILL BE TRACKED THROUGH QUARTERLY TREND REQUEST (B)(4). CONCLUSIONS: AS PART OF THE INVESTIGATION INTO THIS COMPLAINT, THE STRYKER REP THAT WAS PRESENT FOR THE CASE WAS CONTACTED. IT WAS DETERMINED THAT THE SURGEON DID NOT USE THE DRILL GUIDE DURING PLACEMENT OF THE BONE PINS. DUE TO THE NON-USE OF A DRILL GUIDE AS REQUIRED PER MAKOPLASTY PARTIAL KNEE APPLICATION USER GUIDE, 206388 REVISION 01 FOR PLACEMENT OF BONE PINS, THIS EVENT CONSTITUTES AN OFF-LABEL USE OF THE DEVICE. 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 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

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    763858 BONE PIN- 3.2MM X 140MM- STERILE 2 PACK STEREOTACTIC DEVICE, ACCESSORY OLO MAKO SURGICAL CORP. W41380-1

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other