BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 5389620 · Received January 25, 2016

    Report

    Report Number
    3005985723-2016-00042
    Event Type
    Injury
    Date Received
    January 25, 2016
    Date of Event
    January 22, 2016
    Report Date
    January 22, 2016
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    PMA / PMN Number
    K112507
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1 AND FINAL REPORT SUBMITTED TO CORRECT AND TO UPDATE BASED ON THE RESULTS OF INVESTIGATION. REPORTED EVENT: DURING PARTIAL KNEE REPLACEMENT SURGERY, A 3.2X140MM BONE PIN BROKE OFF AND EMBEDDED IN PATIENT. THE FRAGMENT OF BONE PIN WAS LEFT IN THE PATIENT'S TIBIA. 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 (111621 NON-STERILE BONE PIN, SINGLE) WERE MANUFACTURED AND SHIPPED TO (B)(4) ON 10/24/2014 AND ACCEPTED INTO FINAL STOCK ON 10/24/2014 PER ERP. COMPLAINT HISTORY REVIEW: A REVIEW OF COMPLAINTS IN (B)(6) RELATED TO P/N 111620, LOT NUMBER W38525 SHOWS ONE COMPLAINT RELATED TO THE FAILURE IN THIS INVESTIGATION. THE ASSOCIATED PI NUMBER IS (B)(4). TRACKING OF COMPLAINTS RELATED TO THE 111620 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 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) AND RESTORIS MULTICOMPARTMENTAL KNEE (MCK) IMPLANTS. 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) AND RESTORIS MULTICOMPARTMENTAL KNEE (MCK) IMPLANTS. 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
    47473 BONE PIN, 3.2 X 140MM, STERILE (2 PACK) STEREOTACTIC DEVICE, ACESSORY OLO MAKO SURGICAL CORP. N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Other