BEUDAMED
    FDA Adverse Event Injury Summary report: N

    Z NAIL CMF 11.5MMX17.5CM 125R

    MDR report key: 13759261 · Received March 14, 2022

    Report

    Report Number
    0009613350-2022-00148
    Event Type
    Injury
    Date Received
    March 14, 2022
    Date of Event
    February 14, 2022
    Report Date
    May 16, 2022
    Manufacturer
    ZIMMER SWITZERLAND MANUFACTURING GMBH
    Product Code
    HSB
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MEDICAL PRODUCT: Z NAIL CMF 10.5 X 95 LAG SCR CATALOG#: 47-2499-095-10 ; LOT#: 3073401. TLS COMPRESSION DEVICE: CATALOG#: 00-2490-101-22; LOT#: UNKNOWN . CMF TORQUE LIMITING HANDLE: CATALOG#: 00-2490-101-24; LOT#: UNKNOWN. THE MANUFACTURER DID NOT RECEIVE X-RAYS, OR OTHER SOURCE DOCUMENTS FOR REVIEW. THE MANUFACTURER DID NOT RECEIVE THE DEVICE FOR 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). THE FOLLOWING REPORTS ARE ASSOCIATED WITH THIS EVENT: 0009613350-2022-00146. REMAINS IMPLANTED.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. EVENT DESCRIPTION: IT WAS REPORTED THAT INITIAL OPERATION WAS PERFORMED WITH CMF NAIL SYSTEM ON (B)(6) 2021. AFTER 2 MONTHS 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. REVIEW OF RECEIVED DATA: NO MEDICAL RECORDS HAVE BEEN RECEIVED. DUE DILIGENCE: NO FURTHER DUE DILIGENCE REQUIRED AS ALL REQUIRED INFORMATION TO SUPPORT THE CONCLUSION IS AVAILABLE OR WAS ALREADY REQUESTED. 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: 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. COMPLAINT HISTORY REVIEW: REVIEW OF COMPLAINT HISTORY IDENTIFIED NO ADDITIONAL SIMILAR COMPLAINTS FOR THE REPORTED ITEM AND NO ADDITIONAL COMPLAINTS FOR THE REPORTED PART AND LOT COMBINATION RELATED TO THE EVENT. CONCLUSION: IT WAS REPORTED THAT INITIAL OPERATION WAS PERFORMED WITH CMF NAIL SYSTEM ON (B)(6) 2021. AFTER 2 MONTHS 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. 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. NO MEDICAL RECORDS HAVE BEEN RECEIVED. 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

    IT WAS REPORTED THAT INITIAL OPERATION WAS PERFORMED WITH CMF NAIL SYSTEM. AFTER 2 MONTHS 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.

    Description of Event or Problem · 0

    NO CHANGE TO PREVIOUSLY REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    279371 Z NAIL CMF 11.5MMX17.5CM 125R TRAUMA PROSTHESIS HSB ZIMMER SWITZERLAND MANUFACTURING GMBH N/A 3056778

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Hospitalization