BEUDAMED
    FDA Adverse Event Other Summary report: N

    3.2MM THREADED PIN, 450MM

    MDR report key: 4959912 · Received July 29, 2015

    Report

    Report Number
    9613350-2015-00917
    Event Type
    Other
    Date Received
    July 29, 2015
    Date of Event
    July 15, 2015
    Report Date
    July 15, 2015
    Manufacturer
    ZIMMER GMBH
    Product Code
    HSB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER DID NOT RECEIVE DEVICE, X-RAYS, OR OTHER SOURCE DOCUMENTS FOR REVIEW, BUT IT IS MENTIONED BY COMPLAINANT THAT THE INSTRUMENT WILL BE RETURNED. WHERE LOT NUMBERS WERE RECEIVED FOR THE DEVICES, THE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. A CAUSE FOR THIS SPECIFIC EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED. AS SOON AS ADDITIONAL INFORMATION BECOME AVAILABLE AND/OR AN INVESTIGATION RESULT BE AVAILABLE, AN AMENDED MEDICAL DEVICE REPORT WILL BE SUBMITTED. ZIMMER'S REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Additional Manufacturer Narrative · 1

    THE DEVICE MANUFACTURING QUALITY RECORDS INDICATE THAT THE RELEASED COMPONENTS MET ALL REQUIREMENTS TO PERFORM AS INTENDED. NO TREND WAS IDENTIFIED. VISUAL EXAMINATION: THE THREADED PIN IS BROKEN. THE RETURNED PART SHOWS CIRCULAR SIGNS WHICH MOST PROBABLY HAVE BEEN ORIGINATED FROM THE REAMER. NO OTHER TESTS WERE RELEVANT FOR THE INVESTIGATION. REVIEW OF INTERNAL DOCUMENTS: INSPECTION PLAN SAP WAS REVIEWED: THE SURFACE WAS 100% CHECKED FOR QUALITATIVE EXAMINATION. THE SURGICAL TECHNIQUE ZIMMER NATURAL NAIL SYSTEM CEPHALOMEDULLARY NAIL SURGICAL TECHNIQUE CONTAINS INFORMATION AND ILLUSTRATIONS ABOUT THE POSITIONING OF THE LAG SCREW. POSSIBLE CAUSES FOR THE REPORTED EVENT ACCORDING TO SAP DFMEA: GUIDE PIN FRACTURES OR BENDS -> DUE TO EXCESSIVE FORCE OR TORQUE APPLIED TO PART. THERE IS THE EVIDENCE OF THE USE OF EXCESSIVE FORCE OR TORQUE. IF THE PROCEDURE DESCRIBED IN THE SURGICAL TECHNIQUE IS FOLLOWED, THIS SHOULD NOT HAPPEN. BASED ON THE GIVEN INFORMATION AND THE RESULTS OF THE INVESTIGATION, WE COULD IDENTIFY A ROOT CAUSE FOR THIS ISSUE. EXCESSIVE FORCE OR TORQUE WERE APPLIED TO PART. THE NEED FOR CORRECTIVE MEASURES IS NOT INDICATED AND ZIMMER GMBH CONSIDERS THIS CASE AS CLOSED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE 3.2MM THREADED PIN 450MM BROKE DURING SURGERY ON (B)(6) 2015 WHILE REMOVING THE LAG SCREW REAMER. IT WAS REPORTED THAT THE DISTAL FRAGMENT OF THE PIN GOT STUCK INTO THE ACETABULUM. IT WAS DIFFICULT TO EXTRACT THE BROKEN FRAGMENT AND DAMAGES WERE MADE ON THE FEMORAL HEAD AS A CONSEQUENCE OF THE REMOVAL PROCEDURE. THE SURGERY WAS DELAYED FOR 120 MINUTES AND WAS COMPLETED WITH ANOTHER DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    492355 3.2MM THREADED PIN, 450MM ZIMMER NATURAL NAIL SYSTEM CEPHALOMEDU HSB ZIMMER GMBH NA 15150583

    Patients

    Seq Age Sex Outcome Treatment
    1 Other