BEUDAMED
    FDA Adverse Event Injury Summary report: N

    Z NAIL CMF 11.5MMX17.5CM 125R

    MDR report key: 12412685 · Received September 2, 2021

    Report

    Report Number
    0009613350-2021-00454
    Event Type
    Injury
    Date Received
    September 2, 2021
    Date of Event
    July 27, 2021
    Report Date
    November 24, 2021
    Manufacturer
    ZIMMER SWITZERLAND MANUFACTURING GMBH
    Product Code
    HSB
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS PRODUCT IS MANUFACTURED BY ZIMMER BIOMET WINTERTHUR AND IS NOT CLEARED OR DISTRIBUTED IN THE U.S. HOWEVER, THIS REPORT IS BEING SUBMITTED AS ZIMMER BIOMET WINTERTHUR MANUFACTURES A SIMILAR DEVICE THAT IS CLEARED OR DISTRIBUTED IN THE UNITED STATES. D10: MEDICAL PRODUCTS: Z NAIL CMF 10.5 X 85 LAG SCR; CATALOG# 47-2499-085-10; LOT#3054634; 5.0 MM DIAMETER CORTICAL SCREW - RED FIXED ANGLE 3.5 MM HEX HEAD; CATALOG#: 47-2484-030-50; LOT#: 64677271; Z NAIL CMF 5.0X65 ANT SUP SCR; CATALOG#: 47-2501-065-50; LOT#: 3050804; Z NAIL CMF NAIL CAP 0MM; CATALOG#: 47-2500-002-00; LOT#: 3056984; TLS COMPRESSION DEVICE; CATALOG#: 00-2490-101-22; LOT#: UNKNOWN; CMF TORQUE LIMITING HANDLE; CATALOG#: 00-2490-101-24; LOT#: UNKNOWN. THERAPY DATE: UNKNOWN. THIS FOLLOW-UP REPORT IS BEING FILLED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE PREVIOUS MEDWATCH. ADDITIONAL INFORMATION WAS RECEIVED ON SEP 9, 2021. THE MANUFACTURER RECEIVED OTHER SOURCE DOCUMENTS FOR REVIEW. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE AND OR THE DEVICE(S) BE RETURNED FOR EVALUATION AND AN INVESTIGATION RESULT BE AVAILABLE, THAT CHANGES THIS ASSESSMENT, AN AMENDED MEDICAL DEVICE REPORT WILL BE SUBMITTED. ZIMMER¿S REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY CORRECTED AND ADDITIONAL INFORMATION. EVENT DESCRIPTION: INITIAL OPERATION WAS PERFORMED WITH CMF NAIL SYSTEM ON (B)(6) 2021. AFTER 3 MONTHS FROM IT, SURGEON CONFIRMED X-RAYS AND HE FOUND THE LAG SCREW WAS SLIDING TO OUTER SIDE. THE SURGEON KEEP AN EYE ON THE PATIENT CONDITION AS WELL AS NO REVISION WILL BE PLANNED SO FAR. REVIEW OF RECEIVED DATA: DUE DILIGENCE: NO FURTHER DUE DILIGENCE REQUIRED AS ALL REQUIRED INFORMATION TO SUPPORT THE CONCLUSION IS AVAILABLE OR WAS ALREADY REQUESTED. X-RAYS: ONLY ONE X-RAY PICTURE HAS BEEN RECEIVED. THE REVIEW WAS DONE BY PROF. (B)(6). FRAGMENT MEDIAL MIGRATION DUE TO INITIAL REDUCTION. CONSIDERING THE FRACTURE TYPE AND REDUCTION, A STILL ACCEPTABLE RESULT. THE FORTIS SYSTEM SAVED THIS CASE. PRODUCT EVALUATION: NO PRODUCT WAS RETURNED; THEREFORE, VISUAL AND DIMENSIONAL EVALUATION COULD NOT BE PERFORMED. REVIEW OF PRODUCT DOCUMENTATION: DEVICE PURPOSE: ALL INVOLVED DEVICES ARE INTENDED FOR TREATMENT. PRODUCT COMPATIBILITY: THE PRODUCT COMBINATION WAS APPROVED BY ZIMMER BIOMET. DHR REVIEW: REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. SURGICAL TECHNIQUE SAP: THE CORRECT IMPLANTATION AND INSERTION (TLS PLACEMENT AND SET SCREW LOCKING) IS DESCRIBED IN THE SURGICAL TECHNIQUE. PLEASE ALSO NOTE THE FOLLOWING SECTION REGARDING SET SCREW LOCKING: AFTER THE TLS IS PLACED, THE PRE-ASSEMBLED SETSCREW IN THE NAIL MUST BE TIGHTENED WITH THE TORQUE LIMITING HANDLE OFFERED WITH THE SYSTEM, TO PREVENT THE TLS SLEEVE FROM MOVING POST-OPERATIVELY. AN ANTERIOR SUPPORT SCREW CAN BE PLACED IN ADDITION TO THE TLS TO PROVIDE ROTATIONAL STABILITY AND SUPPORT THE TREATMENT OF UNSTABLE INTERTROCHANTERIC FRACTURES WITH LARGE POSTEROMEDIAL (LESSER TROCHANTER) AND POSTEROLATERAL (GREATER TROCHANTER) FRAGMENTS, PREVENTING EXCESSIVE LAG SCREW SLIDING POST-OPERATION. CONCLUSION: INITIAL OPERATION WAS PERFORMED WITH CMF NAIL SYSTEM ON (B)(6) 2021. AFTER 3 MONTHS, SURGEON CONFIRMED X-RAYS AND HE FOUND THE LAG SCREW WAS SLIDING TO OUTER SIDE. THE SURGEON KEEP AN EYE ON THE PATIENT CONDITION AS WELL AS NO REVISION WILL BE PLANNED SO FAR. THE QUALITY RECORDS SHOW THAT ALL SPECIFIED CHARACTERISTICS (MATERIAL, DIMENSIONS, SURFACE, ETC.) FOR THE AFFECTED PRODUCTS HAVE MET THE SPECIFICATIONS VALID AT THE TIME OF PRODUCTION. NO PRODUCT WAS RETURNED, HENCE VISUAL AND DIMENSIONAL EVALUATION COULD NOT BE PERFORMED; THEREFORE, THE CONDITION OF THE PARTS IS UNKNOWN. IT WAS REPORTED THAT THERE WERE NO CONTRIBUTING CONDITIONS RELATED TO THE EVENT. FURTHER IT IS MENTIONED THAT THE SURGICAL TECHNIQUE FOR THE PRODUCT WAS UTILIZED WITHOUT PROBLEM. BASED ON THE AVAILABLE INFORMATION IT IS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE FOR THIS ISSUE. A FURTHER AND MORE COMPREHENSIVE INVESTIGATION IS UNDERGOING TO DETERMINE THE NECESSITY OF POTENTIAL CORRECTIVE AND/OR PREVENTIVE ACTIONS. ACCORDING TO THE CURRENT AVAILABLE INFORMATION, THERE ARE NO CONFIRMED PRODUCT NONCONFORMITY RELATED TO THE ISSUE. THERE ARE ALSO NO KNOWN DESIGN OR MANUFACTURING RELATED ISSUE TO THE ZNN CM FORTIS NAILS AND LAG SCREWS AT THIS TIME. A POSSIBLE CONTRIBUTING FACTOR FOR THE MIGRATION COULD BE A MALREDUCTION OR A REALLY UNSTABLE FRACTURE. BY CONSIDERING THESE FACTORS AND THE CORRESPONDING USE OF THE SYSTEM, GOOD RESULTS CAN BE EXPECTED EVEN IN THIS DEMANDING SITUATIONS. THIS IS ALSO CONFIRMED BY AN HCP REVIEW. IT IS ALSO MENTIONED THAT A MINOR BACKOUT OF THE TLS IS NOT A CLINICAL ISSUE. THE NEED FOR CORRECTIVE MEASURES IS NOT INDICATED AND ZIMMER SWITZERLAND. MANUFACTURING GMBH CONSIDERS THIS CASE AS CLOSED. ZIMMER BIOMET¿S REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Description of Event or Problem · 0

    PATIENT WAS IMPLANTED ON AN UNKNOWN SIDE AND 3 MONTHS POST IMPLANTATION FROM X-RAY IT WAS REPORTED THAT THE LAG SCREW WAS SLIDING OUTER SIDE. THE SURGEON IS MONITORING THE PATIENT'S CONDITION AND A REVISION SURGERY HAS NOT YET BEEN PLANNED.

    Description of Event or Problem · 0

    NO CHANGE TO PREVIOUSLY REPORTED EVENT.

    Additional Manufacturer Narrative · 1

    MEDICAL PRODUCT: FORTIS LAGSCREW HIP IMPL WIN GEN; ITEM# : UNKNOWN; LOT# : UNKNOWN. THERAPY DATE: UNKNOWN. THE MANUFACTURER RECEIVED X-RAYS AND OTHER SOURCE DOCUMENTS FOR REVIEW. THE MANUFACTURER DID NOT RECEIVE THE DEVICE FOR INVESTIGATION. AS NO LOT NUMBER WAS PROVIDED, THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED. 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 A TLS BACKOUT WAS IDENTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1316129 Z NAIL CMF 11.5MMX17.5CM 125R TRAUMA PROSTHESIS HSB ZIMMER SWITZERLAND MANUFACTURING GMBH N/A 3056778

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Hospitalization SEE H10 NARRATIVE| SEE H10 NARRATIVE.