BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 5231045 · Received November 17, 2015

    Report

    Report Number
    3005985723-2015-00252
    Event Type
    Malfunction
    Date Received
    November 17, 2015
    Date of Event
    November 11, 2015
    Report Date
    November 11, 2015
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    PMA / PMN Number
    K112507
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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: DURING PARTIAL KNEE REPLACEMENT SURGERY, THE TIP OF A 3.2X80MM BONE PIN BROKE OFF AND EMBEDDED IN PATIENT. THE FRAGMENT OF BONE PIN WAS LEFT IN THE PATIENT'S BONE AND CONFIRMED IN POST-OP X-RAY. 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 (111671 NON-STERILE BONE PIN, SINGLE) WERE MANUFACTURED SHIPPED TO (B)(4) ON 08/21/2015 AND ACCEPTED INTO FINAL STOCK ON 08/21/2015 PER ERP. COMPLAINT HISTORY REVIEW: A REVIEW OF COMPLAINTS IN TRACKWISE AND CATSWEB RELATED TO P/N 111670, LOT NUMBER W39919 SHOWS NO COMPLAINTS RELATED TO THE FAILURE IN THIS INVESTIGATION. TRACKING OF COMPLAINTS RELATED TO THE 111670 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 ON THREE SEPARATE OCCASIONS TO DETERMINE IF THE PARALLEL DRILL GUIDE WAS USED. AFTER THESE ATTEMPTS TO DETERMINE IF THE DRILL GUIDE WAS USED DURING PLACEMENT OF THE BONE PINS (FIRST REQUEST WAS (B)(6) 2015; FINAL ATTEMPT WAS (B)(6) 2016) NO RESPONSE WAS RECEIVED REGARDING THE USE OF THE DRILL GUIDE. IT CANNOT BE DETERMINED IF THE SURGEON USED THE DRILL GUIDE DURING PLACEMENT OF THE BONE PINS. HOWEVER, TO DATE FOUR COMPLAINT INVESTIGATIONS HAVE BEEN COMPLETED FOR THIS PART NUMBER. OF THOSE FOUR COMPLAINT INVESTIGATIONS, NO COMPLAINTS HAVE BEEN INVESTIGATED WHERE THE BONE PINS WERE INSERTED USING A DRILL GUIDE AND WERE BROKEN INTRAOPERATIVELY . IT IS POSSIBLE THAT THE SURGEON DID NOT USE THE DRILL GUIDE DURING THE PLACEMENT OF THE BONE PINS AS THE DEVICES WERE WITHIN SPECIFICATION ACCORDING TO THE DHR DOCUMENTATION INCLUDED IN ATTACHMENT 1. 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.

    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 TIP OF THE BONE PIN BROKE OFF IN THE PATIENT'S TIBIA. IT WAS DISCOVERED ON POST-OP X-RAY.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). DURING THE CASE, THE TIP OF THE BONE PIN BROKE OFF IN THE PATIENT'S TIBIA. IT WAS DISCOVERED ON POST-OP X-RAY. 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
    760394 BONE PIN, 3.2 X 80 MM, STERILE (2 PACK) STEREOTACTIC DEVICE, ACCESSORY OLO MAKO SURGICAL CORP. W39919-1

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other