BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    Z NAIL CMF 10.5 X 90 LAG SCR

    MDR report key: 12932118 · Received December 6, 2021

    Report

    Report Number
    0009613350-2021-00643
    Event Type
    Malfunction
    Date Received
    December 6, 2021
    Date of Event
    September 8, 2021
    Report Date
    December 6, 2021
    Manufacturer
    ZIMMER SWITZERLAND MANUFACTURING GMBH
    Product Code
    HWC
    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. MEDICAL PRODUCTS: Z NAIL CMF NAIL CAP 0MM CATALOG: 47250000200; LOT: 3059715; 5.0 MM DIAMETER CORTICAL SCREW - RED FIXED ANGLE 3.5 MM HEX HEAD CATALOG: 47248403250; LOT: 64935045; 5.0 MM DIAMETER CORTICAL SCREW - RED FIXED ANGLE 3.5 MM HEX HEAD CATALOG: 47248403550; LOT: 64935026; Z NAIL CMF 5.0X70 ANT SUP SCR CATALOG:47250107050; LOT: 3050805. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS, AS THE DEVICES REMAIN IMPLANTED. INVESTIGATION RESULTS WERE MADE AVAILABLE. EVENT DESCRIPTION: IT WAS REPORTED THAT IMPLANTATION OF THE CMF NAIL SYSTEM WAS PERFORMED ON (B)(6) 2021. THE RADIOGRAPHICAL EVALUATION 4 WEEKS LATER SHOWED THAT THE LAG SCREW MIGRATED TO THE OUTER SIDE. THE SURGEON IS KEEPING AN EYE ON THE PATIENT; THERE IS NO REVISION PLANNED. PATIENT INVOLVED. HARM: S2 - INSTABILITY, MINOR. HAZARDOUS SITUATION: IMPLANT DETERIORATES, BREAKS OR LOSES FUNCTION POSTOPERATIVELY. 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: TWO UNDATED X-RAYS HAVE BEEN RECEIVED. THE FOLLOWING EVALUATION HAS BEEN PERFORMED BY PROF. (B)(6) AND DR. (B)(6) (TAKEN FROM (B)(4)). THE FRACTURE REDUCTION APPEARS APPROPRIATE, HOWEVER THE TLS APPEARS TOO SHORT AND TOO LOW IN POSITION. THE SLIDING LED TO COLLAPSING OF THE PROXIMAL FRAGMENT INTO THE MEDULLARY CANAL (FRACTURE STABILIZATION). PRODUCT EVALUATION: THE DEVICES REMAIN IMPLANTED. 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 RELEVANT DEVIATIONS OR ANOMALIES DURING MANUFACTURING. SURGICAL TECHNIQUE: SURGICAL TECHNIQUE SAP 3045-JP-EN REV 0: 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 IMPLANTATION OF THE CMF NAIL SYSTEM WAS PERFORMED ON (B)(6) 2021. THE RADIOGRAPHICAL EVALUATION 4 WEEKS LATER SHOWED THAT THE LAG SCREW MIGRATED TO THE OUTER SIDE. THE SURGEON IS KEEPING AN EYE ON THE PATIENT; THERE IS NO REVISION PLANNED. THE QUALITY RECORDS SHOW THAT ALL SPECIFIED CHARACTERISTICS HAVE MET THE SPECIFICATIONS VALID AT THE TIME OF PRODUCTION. THEREFORE, THE INVESTIGATION DID NOT IDENTIFY A NONCONFORMANCE OR A COMPLAINT OUT OF BOX (COOB). BASED ON THE RADIOGRAPHS PROVIDED, THE REPORTED SLIDING CAN BE CONFIRMED. NO PRODUCT WAS RETURNED, HENCE VISUAL AND DIMENSIONAL EVALUATION COULD NOT BE PERFORMED; THEREFORE, THE CONDITION OF THE PARTS IS UNKNOWN. BASED ON THE AVAILABLE INFORMATION IT IS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE FOR THIS ISSUE. A FURTHER AND MORE COMPREHENSIVE INVESTIGATION WAS INITIATED 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 (B)(4) MANUFACTURING GMBH CONSIDERS THIS CASE AS CLOSED. ZIMMER BIOMET'S REFERENCE NUMBER OF THIS FILE IS 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). THE FOLLOWING REPORTS ARE ASSOCIATED WITH THIS EVENT: 0009613350-2021- 00642.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT IMPLANTATION OF THE CMF NAIL SYSTEM WAS PERFORMED ON (B)(6) 2021. THE RADIOGRAPHICAL EVALUATION 4 WEEKS LATER SHOWED THAT THE LAG SCREW MIGRATED TO THE OUTER SIDE. THE SURGEON IS KEEPING AN EYE ON THE PATIENT; THERE IS NO REVISION PLANNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1829906 Z NAIL CMF 10.5 X 90 LAG SCR TRAUMA PROSTHESIS HWC ZIMMER SWITZERLAND MANUFACTURING GMBH N/A 3070339

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Male Hospitalization