BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BONE PIN, 3.2MM X 80MM, STERILE 2 PACK

    MDR report key: 6104435 · Received November 15, 2016

    Report

    Report Number
    3005985723-2016-00382
    Event Type
    Injury
    Date Received
    November 15, 2016
    Date of Event
    November 7, 2016
    Report Date
    November 7, 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: WHEN PULLING OUT THE TIBIAL BONE PINS, THE DR COMMENTED THAT THE TIP OF ONE OF THEM BROKE OFF IN THE PATIENT. NO REPORTED DELAY IN SURGERY. SURGERY WAS SUCCESSFUL. DEVICE EVALUATION AND RESULTS: NOT PERFORMED AS THE DEVICE WAS NOT RETURNED FOR EVALUATION. DEVICE HISTORY REVIEW: REVIEW OF THE DEVICE HISTORY RECORDS (SEE ATTACHMENT 1) FOR THE ASSOCIATED LOT INDICATED (B)(4) DEVICES (143000-01 NON-STERILE BONE PIN, SINGLE) WERE MANUFACTURED SHIPPED TO (B)(4) ON MAY 23, 2016 AND ACCEPTED INTO FINAL STOCK ON MAY 23, 2016 PER ERP. COMPLAINT HISTORY REVIEW: A REVIEW OF COMPLAINTS IN (B)(6) RELATED TO P/N 143080, LOT NUMBER W44720-3 SHOWS ONE ADDITIONAL COMPLAINT RELATED TO THE FAILURE IN THIS INVESTIGATION, (B)(4). TRACKING OF COMPLAINTS RELATED TO THE 143080 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 THROUGH AN EMAIL (B)(6) 2016 THAT THE SURGEON DID USE THE DRILL GUIDE DURING PLACEMENT OF THE BONE PIN. THE BONE PIN BROKE 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. THE DEVICE WAS NOT RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    THE SURGEON PERFORMED A PARTIAL KNEE ARTHROPLASTY PROCEDURE USING THE ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM (RIO). WHEN PULLING OUT THE TIBIAL BONE PINS, THE SURGEON COMMENTED THAT HE TIP OF ONE OF THEM BROKE OFF IN THE PATIENT.

    Description of Event or Problem · 1

    THE SURGEON PERFORMED A PARTIAL KNEE ARTHROPLASTY PROCEDURE USING THE ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM (RIO). WHEN PULLING OUT THE TIBIAL BONE PINS, THE SURGEON COMMENTED THAT THE TIP OF ONE OF THEM BROKE OFF IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    754024 BONE PIN, 3.2MM X 80MM, STERILE 2 PACK STEREOTACTIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP. LOT: W44720-3

    Patients

    Seq Age Sex Outcome Treatment
    1 Other