BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 5310386 · Received December 18, 2015

    Report

    Report Number
    3005985723-2015-00308
    Event Type
    Malfunction
    Date Received
    December 18, 2015
    Date of Event
    December 8, 2015
    Report Date
    December 8, 2015
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    PMA / PMN Number
    K112507
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    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 PLACING A 3.2 X 80 PIN IN THE TIBIA FOR ARRAY PLACEMENT, TIP OF PIN BROKE OFF AND BECAME LODGED IN THE POSTERIOR CORTICAL WALL. PIN WAS REMOVED AND NEW PIN WAS OPEN AND PLACE SUCCESSFULLY. 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 (143000-01 NON-STERILE BONE PIN, SINGLE) WERE MANUFACTURED SHIPPED TO (B)(4) ON JULY 2, 2015 AND ACCEPTED INTO FINAL STOCK ON JULY 2, 2015 PER ERP. COMPLAINT HISTORY REVIEW: A REVIEW OF COMPLAINTS IN (B)(6) RELATED TO P/N 143080, LOT NUMBER W41375 SHOWS THREE COMPLAINTS RELATED TO THE FAILURE IN THIS INVESTIGATION. THE RELATED PI NUMBERS ARE (B)(4). AT THE TIME OF THIS INVESTIGATION, THE INVESTIGATION FOR (B)(4) HAD BEEN COMPLETED. 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 COULD NOT BE DETERMINED WHETHER THE SURGEON USED THE PARALLEL DRILL GUIDE DURING THE PLACEMENT OF THE BONE PINS. THE STRYKER REP STATED "I CANNOT SAY WHETHER THE GUIDES WERE USED IN THIS ACCOUNT BECAUSE OF THE INTERMITTENT USE OF THE GUIDES." WHILE IT CANNOT BE DETERMINED IF THE SURGEON USED THE DRILL GUIDE DURING PLACEMENT OF THE BONE PINS, TO DATE THREE COMPLAINT INVESTIGATIONS HAVE BEEN COMPLETED FOR THIS PART NUMBER. OF THOSE THREE COMPLAINT INVESTIGATIONS, INCLUDING ONE FOR THIS LOT NUMBER, 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. 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

    FOLLOW-UP #2 SUBMITTED TO CORRECT SECTIONS BASED ON THE RESULTS OF INVESTIGATION.

    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. THE SURGEON REMOVED THE TIP OF THE BONE PIN FROM THE POSTERIOR CORTICAL WALL 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. THE SURGEON REMOVED THE TIP OF THE BONE PIN FROM THE POSTERIOR CORTICAL WALL 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. THE SURGEON REMOVED THE TIP OF THE BONE PIN FROM THE POSTERIOR CORTICAL WALL IN THE PATIENT'S TIBIA. THE OUTCOME OF THE CASE WAS SUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    837658 BONE PIN, 3.2MM X 80MM, STERILE 2 PACK STEREOTACTIC DEVICE, ACCESSORY OLO MAKO SURGICAL CORP. W41375-1

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Other