BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    Z NAIL CMF 10.5 X 105 LAG SCR

    MDR report key: 13117835 · Received December 30, 2021

    Report

    Report Number
    0009613350-2021-00688
    Event Type
    Malfunction
    Date Received
    December 30, 2021
    Date of Event
    November 29, 2021
    Report Date
    January 28, 2022
    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 FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. UPDATED: A2, A3, D10, E1, H2, H6, H10 D10: MEDICAL PRODUCT: Z NAIL 5.0X32.5 CORT SCREW FA, CATALOG#: 47-2484-032-50; LOT#: 65070093. Z NAIL CMF 5.0X85 ANT SUP SCR, CATALOG#: 47-2501-085-50; LOT#: 3050807. TLS COMPRESSION DEVICE, CATALOG#: 00.249010.122; LOT#: UNKNOWN. EVENT DESCRIPTION: IT WAS REPORTED THAT: INITIAL OPERATION WAS PERFORMED WITH CMF NAIL SYSTEM ON (B)(6) 2021. AFTER 2 WEEKS FROM THE INITIAL, 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. PATIENT INVOLVED. NO DELAY. 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: SEVERAL X-RAYS HAVE BEEN RECEIEVED. IT CAN BE SEEN THAT THE LAG SCREW IS MIGRATED TO OUTER SIDE. THIS CAN BE CONFIRMED. 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: IT WAS REPORTED THAT: INITIAL OPERATION WAS PERFORMED WITH CMF NAIL SYSTEM ON (B)(6) 2021. AFTER 2 WEEKS FROM THE INITIAL, 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. PATIENT INVOLVED. NO DELAY. 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. HOWEVER, THE RECEIVED X-RAYS CONFIRM THE BACKED OUT POST-OPERATIVELY. 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).

    Additional Manufacturer Narrative · 0

    THIS PRODUCT IS MANUFACTURED BY ZIMMER BIOMET (B)(4) AND IS NOT CLEARED OR DISTRIBUTED IN THE U.S. HOWEVER, THIS REPORT IS BEING SUBMITTED AS ZIMMER BIOMET (B)(4) MANUFACTURES A SIMILAR DEVICE THAT IS CLEARED OR DISTRIBUTED IN THE UNITED STATES. MEDICAL PRODUCT: Z NAIL CMF 11.5MMX17.5CM 130R, CATALOG#: 47249818211; LOT#: 3057211. Z NAIL 5.0X32.5 CORT SCREW FA, CATALOG#: 47-2484-032-50; LOT#: 65070093. Z NAIL CMF 5.0X85 ANT SUP SCR, CATALOG#: 47-2501-085-50; LOT#: 3050807. X-RAYS RECEIVED AND WILL BE REVIEWED AS PART OF ONGOING INVESTIGATION. THE LOT NUMBER OF THE DEVICE WAS RECEIVED. THE DEVICE HISTORY RECORDS WILL BE REVIEWED DURING INVESTIGATION. 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 · 0

    NO CHANGE TO PREVIOUSLY REPORTED EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE INITIAL OPERATION WAS PERFORMED WITH CMF NAIL SYSTEM. AFTER 2 WEEKS FROM THE INITIAL, 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2021296 Z NAIL CMF 10.5 X 105 LAG SCR TRAUMA PROSTHESIS HSB ZIMMER SWITZERLAND MANUFACTURING GMBH N/A 3065256

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Male SEE H10 NARRATIVE