BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 5174109 · Received October 24, 2015

    Report

    Report Number
    3005985723-2015-00213
    Event Type
    Malfunction
    Date Received
    October 24, 2015
    Date of Event
    October 21, 2015
    Report Date
    October 21, 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
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1. REPORTED EVENT: THE 3.2 X 140 BONE PIN BROKE WHILE SURGEON WAS REMOVING IT FROM PATIENT'S TIBIA. IT BROKE OFF BELOW THE SURFACE OF THE SKIN AND WAS LEFT IN PATIENT. MINIMAL DELAY TO 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: REVIEW OF THE DEVICE HISTORY RECORDS FOR THE ASSOCIATED LOT INDICATED (B)(4) DEVICES ((B)(4) NON-STERILE BONE PIN, SINGLE) WERE MANUFACTURED AND SHIPPED TO MILLSTONE ON 07/23/2015 AND ACCEPTED INTO FINAL STOCK ON 07/23/2015 PER ERP. COMPLAINT HISTORY REVIEW: A REVIEW OF COMPLAINTS IN TRACKWISE AND CATSWEB RELATED TO P/N 143140, LOT NUMBER W41379-2 SHOWS NO ADDITIONAL COMPLAINTS RELATED TO THE FAILURE IN THIS INVESTIGATION. 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 BOTH BONE PINS. DUE TO THE NON-USE OF A DRILL GUIDE AS REQUIRED PER MAKOPLASTY PARTIAL KNEE APPLICATION USER GUIDE, (B)(4) 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.

    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
    704541 BONE PIN- 3.2MM X 140MM- STERILE 2 PACK STEREOTACTIC DEVICE, ACCESSORY OLO MAKO SURGICAL CORP. W41379-2

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Other