BEUDAMED
    FDA Adverse Event Injury Summary report: N

    8MM OFFSET BROACH/CURVED TIP FOR RADIAL HEAD PROSTHESIS

    MDR report key: 4475749 · Received February 2, 2015

    Report

    Report Number
    2520274-2015-10694
    Event Type
    Injury
    Date Received
    February 2, 2015
    Date of Event
    January 20, 2015
    Report Date
    January 20, 2015
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    KWI
    PMA / PMN Number
    PK112030
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. USED TO CAPTURE UNANTICIPATED INTRA-OPERATIVE X-RAYS. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    PATIENT INITIALS ARE (B)(6). SUBJECT DEVICE HAS BEEN RECEIVED; NO CONCLUSION COULD BE DRAWN AS THE PRODUCT IS ENTERING THE COMPLAINT SYSTEM. DEVICE HISTORY REVIEW: LOT 6905068 - (B)(4) MANUFACTURED THE 8MM OFFSET BROACH/CURVED TIP FOR RADIAL HEAD PROSTHESIS, P/N 03.402.733 AND LOT 6905068. INITIALLY, THE PART CONFORMED TO THE SUPPLIER¿S CERTIFICATE OF CONFORMANCE, DATED NOVEMBER 29, 2012, AND WAS INSPECTED AND CONFORMED TO THE SYNTHES FINAL INSPECTION SHEET. THE PARTS WERE RELEASED TO THE WAREHOUSE ON DECEMBER 4, 2012. THERE WERE NO MATERIAL RECORD REPORTS, NON-CONFORMANCE REPORTS, OR COMPLAINT RELATED ISSUES WITH THIS LOT. DEVICE USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    PRODUCT INVESTIGATION EVALUATION: THE COMPLAINT CONDITION FOR PART NUMBER 03.402.733 (WITH LOT NUMBER 6905068) OFFSET 8.0MM BROACH, CURVED TIP WAS LIKELY CAUSED BY IMPROPER ORIENTATION OF THE FOREARM OR USING TOO LARGE A BROACH; HOWEVER, THIS COMPLAINT IS NOT A RESULT OF ANY DESIGN RELATED DEFICIENCY. THE OFFSET 8.0MM BROACH, CURVED TIP IS AN INSTRUMENT ROUTINELY USED IN THE RADIAL HEAD PROSTHESIS SYSTEM. THE RETURNED DEVICE WAS RECEIVED IN VERY GOOD CONDITION WITH ALMOST NO VISIBLE WEAR. THE DEVICE WAS MANUFACTURED IN DECEMBER 2012 AND IS OVER TWO YEARS OLD. THE DEVICE WAS RETURNED AND REPORTED TO NOT BE ABLE TO BROACH TO THE PROPER DEPTH CAUSING THE IMPLANT TO NOT SEAT ENTIRELY IN THE CANAL. THIS CONDITION IS UNCONFIRMED DUE TO THE INABILITY TO TEST THIS CONDITION; HOWEVER, THE DEVICE IS IN GOOD CONDITION AND IT IS LIKELY THAT THE COMPLAINT CONDITION WAS CAUSED BY EITHER THE SURGEON USING TOO LARGE A BROACH OR THAT THE FOREARM WAS NOT IN THE PROPER POSITION DURING SURGERY. DRAWING WAS REVIEWED AND DETERMINED TO BE SUITABLE FOR THE INTENDED DESIGN, APPLICATION AND DIMENSIONAL CONFORMITY WHEN USED AS RECOMMENDED. DEVICE USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING A PROCEDURE ON (B)(6) 2015 THE SURGEON EXPERIENCED DIFFICULTY WHILE BROACHING THE RADIAL CANAL WITH THE 7MM AND 8MM BROACH. DURING BROACHING WITH THE 8MM BROACH IT WAS NOTED THAT THE LAST 5MM OF USEABLE BROACH LENGTH WOULD NOT ADVANCE ALL THE WAY WHICH RESULTED IN THE 8MM TRIAL STEM NOT FULLY SEATING INTO THE RADIAL CANAL. THIS IN TURN RESULTED IN THE IMPLANT NOT PROPERLY SEATING IN THE RADIAL CANAL AND REMAINING PROMINENT BY 3-5MM. THIS EVENT RESULTED IN A THIRTY MINUTE SURGICAL DELAY AND ADDITIONAL X-RAYS BEING PERFORMED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS IS REPORT 1 OF 5 FOR (B)(4).

    Description of Event or Problem · 1

    UPDATE: IT WAS REPORTED VIA AN UPDATE THAT NO DIFFICULTY OCCURRED WHILE BROACHING WITH THE 7MM BROACH; ONLY WITH THE 8MM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    75129 8MM OFFSET BROACH/CURVED TIP FOR RADIAL HEAD PROSTHESIS PROSTHESIS, ELBOW, HEMI-RADIAL, POLYMER KWI SYNTHES MONUMENT 6905068

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention