BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZNN CMN TRAUMA INST

    MDR report key: 5999237 · Received October 5, 2016

    Report

    Report Number
    0009613350-2016-01250
    Event Type
    Injury
    Date Received
    October 5, 2016
    Date of Event
    September 7, 2016
    Report Date
    September 14, 2016
    Manufacturer
    ZIMMER GMBH
    Product Code
    HSB
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER DID NOT RECEIVE X-RAYS, OR OTHER SOURCE DOCUMENTS FOR REVIEW, NEITHER THE DEVICE HAS BEEN RECEIVED FOR INVESTIGATION AS THE PRODUCTS REMAINED IN THE PATIENT. AS NO LOT NUMBERS WERE PROVIDED FOR THE DEVICES, THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED. A CAUSE FOR THIS SPECIFIC EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THAT CHANGES THIS ASSESSMENT, AN AMENDED MEDICAL REPORT WILL BE SUBMITTED. (B)(4).

    Additional Manufacturer Narrative · 1

    UPDATE: MODEL #/LOT #, DATE RECEIVED BY MFR, TYPE OF REPORTS, IF FOLLOW-UP, WHAT TYPE?, EVALUATION CODES, ADDITIONAL MFR NARRATIVE. ADDITIONAL: IF FOLLOW-UP, WHAT TYPE? AS NO LOT NUMBERS WERE PROVIDED FOR THE INSTRUMENT THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED. AT ZIMMER (B)(4) ALL MEDICAL DEVICES PRIOR RELEASE TO MARKET UNDERGO SEVERAL QUALITY INSPECTIONS AS DEFINED IN OUR QUALITY PROCEDURES. OUR QUALITY INSPECTION- AND DEVIATION PROCEDURES ENSURE THAT ONLY PRODUCTS FULFILLING THE SPECIFICATION ARE SOLD. THESE PROCEDURES ARE PART OF THE OVERALL QUALITY MANAGEMENT SYSTEM AT ZIMMER (B)(4) AND GET REGULARLY AUDITED BY OUR NOTIFIED BODY, COMPETENT AUTHORITIES AND INTERNAL AND EXTERNAL AUDITORS. THUS, FOR ALL PRODUCTS SOLD TO THE MARKET CAN BE ASSUMED HAVING A COMPLETE AND CORRECT DHR. EVENT DESCRIPTION (EVENT DETAILS, PER) - EVENT SUMMARY: IT IS REPORTED THAT POSSIBLY DURING A REVISION SURGERY OF THE NAIL SYSTEM, WHICH WAS IMPLANTED ON (B)(6) 2013, IT WAS NOT POSSIBLE TO EXTRACT THE LAG SCREW FROM THE NAIL, PROBABLY DUE TO THE COLD FUSION BETWEEN THE NAIL AND THE LAG SCREW. IT IS ALSO STATED, THAT THE LAG SCREW TABS BROKE, AS WELL AS THE LAG SCREW EXTRACTING INSTRUMENT. THE NAIL COULD THEREFORE NOT BE REMOVED. REVIEW OF RECEIVED DATA: NO MEDICAL DATA SUCH AS X-RAYS, SURGICAL NOTES OR ANY OTHER CASE-RELEVANT DOCUMENTS RECEIVED. DEVICES ANALYSIS NO PRODUCT WAS RETURNED TO ZIMMER BIOMET FOR IN-DEPTH ANALYSIS. ROOT CAUSE ANALYSIS ROOT CAUSE DETERMINATION USING RMW: - DAMAGE OF THE IMPLANT (TAP-STRIPPING) DUE TO LACK OF ADEQUATE LAG SCREW DESIGN FOR EXTRACTION NOT POSSIBLE - TORSIONAL STRENGTH EVALUATION OF THE ZIMMER NATURAL NAIL CEPHALOMEDULLARY NAIL LAG SCREW TAB INTERFACE AND MATERIAL COMPATIBILITY SPECIFICATION CERTIFY THE DESIGN OF THE LAG SCREW FOR EXTRACTION. - DAMAGE OF LAG SCREW DUE TO USERS NOT CHOOSE THE PROPER ALIGNMENT AND POSITION FOR LAG SCREW PLACEMENT - POSSIBLE, NO X-RAYS WERE RECEIVED FOR THE INVESTIGATION, THEREFORE CANNOT BE EXCLUDED. - SCREW DAMAGE DUE TO USERS APPLY TOO HIGH TORQUE FORCE LEADING TO HEX STRIPPING - POSSIBLE, TOO HIGH FORCE APPLIED ON THE LAG SCREW CAN LEAD TO THE STRIPPING RESULTING IN THE SYSTEM BEING STUCK. CONCLUSION SUMMARY THE NAIL SYSTEM WAS IMPLANTED ON (B)(6) 2013. PROBABLY DURING A REVISION SURGERY THE SURGEON WAS NOT ABLE TO EXTRACT THE LAG SCREW FORM THE NAIL. THE DEVICE MANUFACTURING QUALITY RECORDS INDICATE, THAT THE RELEASED COMPONENTS MET ALL REQUIREMENTS TO PERFORM AS INTENDED. RAW MATERIAL CERTIFICATE OF THE LAG SCREW CONFIRMS, THAT THE PRODUCT WAS MANUFACTURED ACCORDING TO THE MATERIAL SPECIFICATIONS. POSSIBLE REASONS FOR THE REPORTED EVENT ARE THAT WRONG IMPLANTATION POSITION LEADING TO DAMAGE ON LAG SCREW DURING THE TIME IN USE AND/OR HIGH FORCES APPLIED DURING THE EXTRACTION PROCESS WHICH LED TO THE STRIPPING RESULTING THE REPORTED FAILURE. HOWEVER, BASED ON THE GIVEN INFORMATION AND THE RESULTS OF THE INVESTIGATION, WE WERE NOT ABLE TO IDENTIFY A SPECIFIC ROOT CAUSE FOR THIS ISSUE. THE NEED FOR CORRECTIVE MEASURES IS NOT INDICATED AND ZIMMER (B)(4) CONSIDERS THIS CASE AS CLOSED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED A ZNN, CMN LAG SCREW, 10.5 MM, 90 MM, INCLUDING SET SCREW ON THE RIGHT SIDE ON (B)(6) 2013. IT WAS STATED THAT IT WAS NOT POSSIBLE TO EXTRACT THE LAG SCREW FROM THE NAIL, PROBABLY DUE TO COLD FUSION BETWEEN THE NAIL AND THE LAG SCREW (CEPHALIC SCREW). IT WAS ALSO MENTIONED THAT THE LAG SCREW TABS BROKE AS WELL AS THE LAG SCREW EXTRACTING INSTRUMENT. THE NAIL COULD THEREFORE NOT BE REMOVED (AS IT WAS PLANNED).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    652372 ZNN CMN TRAUMA INST ZNN CMN TRAUMA INST HSB ZIMMER GMBH N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Required Intervention