BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BONE PIN- 3.2 X 80 MM- STERILE (2 PACK)

    MDR report key: 4827528 · Received June 9, 2015

    Report

    Report Number
    3005985723-2015-00100
    Event Type
    Injury
    Date Received
    June 9, 2015
    Date of Event
    June 2, 2015
    Report Date
    June 2, 2015
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    PMA / PMN Number
    K112507
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REPORTED EVENT: DURING LEFT PARTIAL KNEE REPLACEMENT SURGERY, THE TIP OF A 3.2X80MM BONE PIN BROKE OFF AND EMBEDDED IN PATIENT AS SURGEON ATTEMPTED TO REMOVE THE ENTIRE PIN. C-ARM XRAY CONFIRMED TIP IN PATIENT. NO DELAY IN SURGERY, SURGERY WAS COMPLETED SUCCESSFULLY. DEVICE EVALUATION AND RESULTS: VISUAL INSPECTION SHOWED FAILURE IN TORSION THROUGH THE THREADS JUST ABOVE THE FLUTES. DEVICE HISTORY REVIEW: REVIEW OF THE DEVICE HISTORY RECORDS FOR LOT W35846 INDICATED (B)(4) DEVICES (111671 NON-STERILE BONE PIN, SINGLE) WERE MANUFACTURED SHIPPED TO (B)(4) ON 12/17/2014 AND ACCEPTED INTO FINAL STOCK ON 12/17/2014 PER ERP. COMPLAINT HISTORY REVIEW: A REVIEW OF COMPLAINTS RELATED TO P/N 111670, LOT NUMBER W35846 SHOWS ONE COMPLAINT RELATED TO THE FAILURE IN THIS INVESTIGATION. THIS COMPLAINT IS: (B)(4). CONCLUSIONS: VISUAL INSPECTION CONFIRMED FAILURE OF THE BONE PIN. 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 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.

    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) AND RESTORIS MULTICOMPARTMENTAL KNEE (MCK) IMPLANTS. DURING THE CASE, THE TIP OF 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) AND RESTORIS MULTICOMPARTMENTAL KNEE (MCK) IMPLANTS. DURING THE CASE, THE TIP OF 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
    372132 BONE PIN- 3.2 X 80 MM- STERILE (2 PACK) STEREOTAXIC DEVICE, ACCESSORY OLO MAKO SURGICAL CORP. W35846-3

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention