BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 6131847 · Received November 29, 2016

    Report

    Report Number
    3005985723-2016-00402
    Event Type
    Injury
    Date Received
    November 29, 2016
    Date of Event
    November 22, 2016
    Report Date
    January 23, 2017
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    PMA / PMN Number
    K142530
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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: 3.2 MM BONE PIN TIP BROKE UPON INSERTION. TIP AND PIN RECOVERED AND REMOVED AND NEW PAIR OPENED AND USED. BROKEN BONE PIN DISCARDED BY SCRUB TECH AND NOT RECOVERED FOR INVESTIGATION. SURGICAL DELAY OF APPROX. 2 MINUTES WHILE NEW PINS WERE RETRIEVED, OPENED AND INSERTED DEVICE EVALUATION AND RESULTS: NOT PERFORMED AS THE DEVICE WAS NOT RETURNED FOR EVALUATION. 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 NOVEMBER 25, 2015 AND ACCEPTED INTO FINAL STOCK ON NOVEMBER 25, 2015 PER ERP. COMPLAINT HISTORY REVIEW: A REVIEW OF COMPLAINTS IN (B)(6) RELATED TO P/N 143080, LOT NUMBER W41377 SHOWS NO ADDITIONAL 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 NOT USE THE DRILL GUIDE DURING PLACEMENT OF THE 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. THE DEVICE WAS NOT RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    WHILE THE SURGEON WAS PERFORMING A PARTIAL KNEE ARTHROPLASTY PROCEDURE USING A 3.2MM BONE PIN, THE TIP OF THE BONE PIN BROKE UPON INSERTION. THE TIP AND PIN WAS RECOVERED AND REMOVED AND A NEW PAIR WAS OPENED AND USED TO PROCEED WITH THE PROCEDURE.

    Description of Event or Problem · 1

    WHILE THE SURGEON WAS PERFORMING A PARTIAL KNEE ARTHROPLASTY PROCEDURE USING A 3.2MM BONE PIN, THE TIP OF THE BONE PIN BROKE UPON INSERTION. THE TIP AND PIN WAS RECOVERED AND REMOVED AND A NEW PAIR WAS OPENED AND USED TO PROCEED WITH THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    782165 BONE PIN, 3.2MM X 80MM, STERILE 2 PACK STEREOTACTIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP. W41377

    Patients

    Seq Age Sex Outcome Treatment
    1 Other