BEUDAMED
    FDA Adverse Event Injury Summary report: N

    Z NAIL CMF 10.5 X 95 LAG SCR

    MDR report key: 12312052 · Received August 12, 2021

    Report

    Report Number
    0009613350-2021-00401
    Event Type
    Injury
    Date Received
    August 12, 2021
    Date of Event
    July 14, 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. THIS FOLLOW-UP REPORT IS BEING FILLED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE PREVIOUS MEDWATCH. ADDITIONAL INFORMATION WHICH WAS RECEIVED ON SEP 03, 2021. THE MANUFACTURER RECEIVED X-RAYS, OTHER SOURCE DOCUMENTS (SURGICAL REPORTS, PHOTOS) 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 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. INVESTIGATION RESULTS WERE MADE AVAILABLE. ADDITIONAL: H2, H6 CORRECTION: B4, B5, G3, G6, H10 1. EVENT DESCRIPTION: IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED WITH A CM FORTIS NAIL ON (B)(6) 2021. 11 WEEKS AFTER IMPLANTATION, THE SURGEON NOTED ON RADIOGRAPHS THAT THE LAG SCREW WAS BACKED OUT. THE SURGEON IS KEEPING AN EYE ON THE PATIENT'S CONDITION, AND NO REVISION HAS BEEN SCHEDULED TO DATE. HARM: S2 - INSTABILITY, MINOR HAZARDOUS SITUATION: IMPLANT DETERIORATES, BREAKS OR LOSES FUNCTION POSTOPERATIVELY. 2. 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 X-RAYS, ONE TAKEN ON (B)(6) 2021 AND ONE TAKEN ON (B)(6) 2021, HAVE BEEN RECEIVED. THE FOLLOWING EVALUATION HAS BEEN PERFORMED BY (B)(6). BASED ON THE MISSING LATERAL RADIOGRAPH THE RESULT OF THE REDUCTION CANNOT BE ASSESSED IN DETAIL. THE TLS POSITION IS NOT OPTIMAL AS IT APPEARS TOO HIGH. A SLIDING CANNOT BE IDENTIFIED WITH CERTAINTY. 3. PRODUCT EVALUATION: - THE DEVICES REMAIN IMPLANTED. 4. 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. 5. CONCLUSION: IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED WITH A CM FORTIS NAIL ON (B)(6) 2021. 11 WEEKS AFTER IMPLANTATION, THE SURGEON NOTED ON RADIOGRAPHS THAT THE LAG SCREW WAS BACKED OUT. THE SURGEON IS KEEPING AN EYE ON THE PATIENT'S CONDITION, AND NO REVISION HAS BEEN SCHEDULED TO DATE. 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 NON-CONFORMANCE OR A COMPLAINT OUT OF BOX (COOB). NO PRODUCT WAS RETURNED, HENCE VISUAL AND DIMENSIONAL EVALUATION COULD NOT BE PERFORMED; THEREFORE, THE CONDITION OF THE PARTS IS UNKNOWN. A SLIDING OF THE LAG SCREW CANNOT BE IDENTIFIED WITH CERTAINTY ON THE X-RAYS. BASED ON THE AVAILABLE INFORMATION IT IS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE FOR THIS ISSUE. A FURTHER AND MORE COMPREHENSIVE INVESTIGATION (IE-19393) 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 11 WEEKS FROM THE INITIAL SURGERY THE SURGEON WITH THE HELP OF X-RAYS NOTICED THAT THE BARREL OF THE LAG SCREW HAS BACKED OUT. THE PATIENT IS BEING MONITORED AND A REVISION SURGERY HAS NOT YET BEEN PLANNED.

    Description of Event or Problem · 0

    INVESTIGATION RESULTS ARE NOW AVAILABLE.

    Additional Manufacturer Narrative · 1

    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: 5.0 MM DIAMETER CORTICAL SCREW - RED FIXED ANGLE 3.5 MM HEX HEAD; CATALOG#: 47-2484-030-50; LOT#: 64935122. Z NAIL CMF 5.0X80 ANT SUP SCR; CATALOG#: 47-2501-080-50; LOT#: 3050654. Z NAIL CMF 11.5MMX17.5CM 130L; CATALOG#: 47-2498-183-11; LOT#: 3059594. Z NAIL CMF NAIL CAP 0MM; CATALOG#: 47-2500-002-00; LOT#: 3057156. THERAPY DATE: UNKNOWN. THE MANUFACTURER RECEIVED X-RAYS FOR REVIEW. OTHER DOCUMENTS WERE RECEIVED AND WILL BE REVIEWED AS PART OF ONGOING INVESTIGATION. WHERE LOT NUMBERS WERE RECEIVED FOR THE DEVICES, THE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. 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

    PATIENT WAS IMPLANTED ON AN UNKNOWN SIDE AND 11 WEEKS FROM THE INITIAL SURGERY THE SURGEON WITH THE HELP OF X-RAYS NOTICED THAT THE BARREL OF THE LAG SCREW HAS BACKED OUT. THE PATIENT IS BEING MONITORED AND A REVISION SURGERY HAS NOT YET BEEN PLANNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1214033 Z NAIL CMF 10.5 X 95 LAG SCR TRAUMA PROSTHESIS HSB ZIMMER SWITZERLAND MANUFACTURING GMBH N/A 3054641

    Patients

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