BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CMN FEMORAL NAIL, CCD 125, RIGHT, 11.5 MM, 21.5 CM

    MDR report key: 6950745 · Received October 16, 2017

    Report

    Report Number
    0009613350-2017-01444
    Event Type
    Injury
    Date Received
    October 16, 2017
    Date of Event
    September 12, 2017
    Report Date
    March 27, 2018
    Manufacturer
    ZIMMER GMBH
    Product Code
    HSB
    PMA / PMN Number
    PK091566
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: ITEM: ZNN CMN LAG SCREW 10.5X90 , CATALOG #: 47-2485-090-10, LOT #: 2843402. TREND ANALYSIS: NO TREND CONSIDERING THE FOLLOWING EVENT IS IDENTIFIED: LAG SCREW NOTCHES BROKEN. DHR-REVIEW: THE DEVICE MANUFACTURING QUALITY RECORDS INDICATE THAT THE RELEASED COMPONENTS MET ALL REQUIREMENTS TO PERFORM AS INTENDED. EVENT DESCRIPTION: IT WAS REPORTED THAT THE TAB OF THE LAG SCREW BROKE OFF DURING REMOVAL OF THE ZNN SYSTEM. REVISION WAS NOT POSSIBLE. EVENT WAS REPORTED TO ANSM. 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. IT WAS REPORTED THAT THE SCREW AND NAIL REMAIN IMPLANTED. REVIEW OF PRODUCT DOCUMENTATION: THE COMPATIBILITY CHECK WAS PERFORMED AND SHOWED THAT THE PRODUCT COMBINATION WAS APPROVED BY ZIMMER BIOMET. THE REMOVAL OF THE LAG SCREW IS DESCRIBED IN THE ZIMMER NATURAL NAIL SYSTEM ¿ CEPHALOMEDULLARY STANDARD SURGICAL TECHNIQUE. "TO REMOVE THE LAG SCREW IT IS NOT NECESSARY THAT THE SET SCREW IS COMPLETELY REMOVED. TURN THE SET SCREW TWO TURNS BACKWARDS AND MAKE SURE THAT THE SET SCREW IS STILL ENGAGED IN THE THREADS OF THE NAIL. IT IS RECOMMENDED TO USE THE LAG SCREW CANNULA AS GUIDANCE FOR THE LAG SCREW INSERTER WHILE REMOVING THE LAG SCREW. ASSEMBLE THE LAG SCREW INSERTER THROUGH THE LAG SCREW CANNULA INTO THE LAG SCREW. USE THE COMPRESSION DEVICE TO PUSH THE LAG SCREW CANNULA TO THE BONE. MAKE SURE THE LAG SCREW INSERTER IS FULLY SEATED. HAND TIGHTEN THE LAG SCREW INSERTER WITH THE 3.5MM HEX SCREWDRIVER. IF A SECONDARY OPTION IS NEEDED TO REMOVE THE LAG SCREW, THE CM LAG SCREW EXTRACTION DEVICE REF 00-2490-090-12 CAN BE USED. TO USE THE CM LAG SCREW EXTRACTION DEVICE, ALIGN ITS AXIS WITH THE AXIS OF THE CM LAG SCREW THAT IS BEING EXPLANTED. THE CONICAL THREAD OF THE CM LAG SCREW EXTRACTION DEVICE SHOULD THEN BE ENGAGED AND ROTATED IN A COUNTER-CLOCKWISE MOTION INTO THE EXPOSED LATERAL THREADS OF THE CM LAG SCREW THAT IS BEING EXPLANTED. THE ROTATION DIRECTION IS COUNTER-CLOCKWISE AS THE CM LAG SCREW EXTRACTION DEVICE UTILIZES REVERSE-CUTTING FLUTES TO ENABLE MATING TO THE CM LAG SCREW. WHILE ROTATING, A CONSTANT AXIAL FORCE MUST BE APPLIED TO MAINTAIN THE TOOL DRIVING INTO THE CM LAG SCREW THREAD. WHILE CONTINUING TO ROTATE THE CM LAG SCREW EXTRACTION DEVICE COUNTER-CLOCKWISE, THE CM LAG SCREW THAT IS BEING EXPLANTED WILL UNSEAT FROM THE BONE AND CAN BE REMOVED". ROOT CAUSE ANALYSIS: ROOT CAUSE DETERMINATION USING RMW: LAG SCREW DAMAGED OR TAP STRIPPING CONNECTION DUE TO USERS APPLY MUCH/NOT ENOUGH FORCES TO TIGHT THE LAG SCREW INSERTER AND THE LAG SCREW LEADING TO DAMAGE OF LAG SCREW OR TAP STRIPPING. => POSSIBLE, IT IS MOST POSSIBLE THAT THE USER DID NOT FULLY CONNECT THE INSERTER WITH THE LAG SCREW. CONCLUSION SUMMARY: IT WAS REPORTED THAT THE TAB OF THE LAG SCREW BROKE OFF DURING REMOVAL OF THE ZNN SYSTEM. REVISION WAS NOT POSSIBLE. THE DEVICE WAS NOT RETURNED FOR INVESTIGATION. THE CORRECT REMOVAL OF THE LAG SCREW IS DESCRIBED IN THE ZIMMER NATURAL NAIL SYSTEM ¿ CEPHALOMEDULLARY STANDARD SURGICAL TECHNIQUE (B)(4). THERE ARE POSSIBLE CAUSES FOR THE BREAKAGE OF THE LAG SCREW TABS DURING THE REMOVAL OF THE ZNN NAILING SYSTEM: IF THE CONTACT SURFACE OF THE INSTRUMENT AND IMPLANT IS TOO SMALL, TOO HIGH FORCES WILL BE TRANSMITTED ON THE CAMS WHICH LEAD TO A FRACTURE OF THIS SECTION. EXCESSIVE BONE INGROWTH ONTO THE LAG SCREW DUE TO LONG IN VIVO TIME OF THE IMPLANT SYSTEM, WHICH MAKES HIGH FORCES NEEDED TO REMOVE THE SCREW IN A REMOVAL CASE. THE IN VIVO TIME IS UNKNOWN. PATHOGENIC BONE DISEASES (E.G. BONE TUMOR) WHICH AFFECT MECHANICAL PROPERTIES OF THE BONE (HARDER/ DENSER BONE SUBSTANCE). HOWEVER, BASED ON THE GIVEN INFORMATION AND THE RESULTS OF THE INVESTIGATION, A SPECIFIC ROOT CAUSE COULD NOT BE DETERMINED. THE NEED FOR CORRECTIVE MEASURES IS NOT INDICATED AND ZIMMER (B)(4) CONSIDERS THIS CASE AS CLOSED. (B)(4)..

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER DID NOT RECEIVE X-RAYS, OR OTHER SOURCE DOCUMENTS FOR REVIEW. THE MANUFACTURER DID NOT RECEIVE THE DEVICE FOR INVESTIGATION. THE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IS CURRENTLY NOT AVAILABLE. A CAUSE FOR THIS SPECIFIC EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED. AS SOON AS SUPPLEMENTAL INFORMATION BECOMES AVAILABLE AN UPDATED REPORT WILL BE SUBMITTED. ZIMMER BIOMET¿S REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED A CMN FEMORAL NAIL, CCD 125, RIGHT, 11.5 MM, 21.5 CM AT AN UNKNOWN DATE ON AN UNKNOWN SIDE AND THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2017 WHERE THE LAG SCREW BROKE OFF DURING REMOVAL OF THE ZNN SYSTEM. REVISION WAS NOT POSSIBLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    732137 CMN FEMORAL NAIL, CCD 125, RIGHT, 11.5 MM, 21.5 CM ZIMMER NATURAL NAIL SYSTEM CEPHALOMEDULLARY NAILS HSB ZIMMER GMBH N/A 2822976

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R