BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 5969065 · Received September 21, 2016

    Report

    Report Number
    3005985723-2016-00297
    Event Type
    Injury
    Date Received
    September 21, 2016
    Date of Event
    September 13, 2016
    Report Date
    September 13, 2016
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    PMA / PMN Number
    K142530
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    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: PART NUMBER 143140 LOT NUMBER W46868. PART NUMBER 143140 LOT NUMBER W43263. PART NUMBER 143080 LOT NUMBER W44720. ROB 377 TWO DIFFERENT 3.2 MM X 140MM BONE PINS AND ONE 3.2 MM X 80MM BONE PIN BROKE OFF IN PATIENT'S LEG TODAY. 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 (SEE ATTACHMENT 1) FOR THE ASSOCIATED LOT INDICATED (B)(4) DEVICES (143000-07 NON-STERILE BONE PIN, SINGLE) WERE MANUFACTURED AND SHIPPED TO (B)(4) ON 05/23/2016 AND ACCEPTED INTO FINAL STOCK ON 05/23/2016 PER ERP. COMPLAINT HISTORY REVIEW: A REVIEW OF COMPLAINTS IN (B)(6) RELATED TO P/N 143140, LOT NUMBER W46868 SHOWS NO OTHER COMPLAINTS RELATED TO THE FAILURE IN THIS INVESTIGATION. TRACKING OF COMPLAINTS RELATED TO THE 143140 PART NUMBER WILL BE TRACKED THROUGH QUARTERLY TREND REQUEST #789. 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 USE THE DRILL GUIDE DURING PLACEMENT OF THE BONE PIN. THE BONE PIN BROKE AND BENT RELATED TO ANOTHER ONE OF THE OTHER POTENTIAL CAUSES FOUND IN 2.0 AFMEA 0007 SYS R35 INCLUDING: EXCESSIVE OFF-AXIS FORCE APPLIED, HIGH PATIENT BONE DENSITY, BONE PIN REUSE FATIGUE, BONE PIN RE-DIRECTED DURING INSERTION, IMPROPER DRILL SPEED USED INCREASING TORQUE ON PIN. BASED ON THIS INVESTIGATION, IT IS NOT POSSIBLE TO DETERMINE WHICH OF THE CAUSE(S) ABOVE CONTRIBUTED TO THE FAILURE. 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.

    Description of Event or Problem · 1

    A SURGEON WAS PERFORMING A PARTIAL KNEE ARTHROPLASTY PROCEDURE USING THE ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM (RIO). DURING THE CASE WHILE THE SURGEON WAS DRILLING A BONE PIN INTO THE PATIENT'S FEMUR, THE BONE PIN BROKE OFF INSIDE OF THE FEMUR. 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). DURING THE CASE WHILE THE SURGEON WAS DRILLING A BONE PIN INTO THE PATIENT'S FEMUR, THE BONE PIN BROKE OFF INSIDE OF THE FEMUR. 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
    617128 BONE PIN- 3.2MM X 140MM- STERILE 2 PACK STEREOTAXIC DEVICE, ACCESSORY OLO MAKO SURGICAL CORP. LOT NUMBER W46868

    Patients

    Seq Age Sex Outcome Treatment
    1 Other