BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    Z NAIL CMF 10.5 X 95 LAG SCR

    MDR report key: 12867723 · Received November 24, 2021

    Report

    Report Number
    0009613350-2021-00607
    Event Type
    Malfunction
    Date Received
    November 24, 2021
    Date of Event
    July 27, 2021
    Report Date
    November 24, 2021
    Manufacturer
    ZIMMER SWITZERLAND MANUFACTURING GMBH
    Product Code
    HWC
    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

    CONCOMITANT MEDICAL PRODUCTS: ITEM# 47248402750, LOT# 64997543, 5.0 MM DIAMETER CORTICAL SCREW - RED FIXED ANGLE 3.5 MM HEX HEAD. ITEM# 47248403050, LOT# 64875654, 5.0 MM DIAMETER CORTICAL SCREW - RED FIXED ANGLE 3.5 MM HEX HEAD. ITEM# 47250000205, LOT# 3056980, Z NAIL CMF NAIL CAP 5MM. ITEM# 47250107550, LOT# 3051838, Z NAIL CMF 5.0X75 ANT SUP SCR. ITEM# 00249010122, LOT# UNKNOWN, TLS COMPRESSION DEVICE. ITEM# 00249010124, LOT# UNKNOWN, CMF TORQUE LIMITING HANDLE. NOT RETURNED TO MANUFACTURER: DEVICE REMAINS IMPLANTED. EVENT DESCRIPTION: IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED WITH A CMF NAIL SYSTEM ON (B)(6) 2021. ONE DAY POST IMPLANTATION SURGERY, THE SURGEON CONFIRMED WITH RADIOLOGICAL IMAGING THAT THE LAG SCREW MIGRATED TOWARDS THE OUTER SIDE. THE PATIENT IS BEING MONITORED AND NO REVISION HAS BEEN PLANNED SO FAR. REVIEW OF RECEIVED DATA: NO MEDICAL DATA RELEVANT TO THE CASE HAS 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 WITH A POTENTIAL CORRELATION TO THE REPORTED EVENT. FOR REF. 47-2498-211-10 / LOT 3054641: 47 PCS. WERE SCRAPPED DUE TO FOUR DIFFERENT DIMENSION OUT OF SPECIFICATION ON THE CMM-PROTOCOL 2 PCS. WERE SCRAPPED DUE TO SCRAP-PIECE DECLARATION MADE BY THE SUPPLIER FOR REF. 47-2498-211-10 / LOT 3052830: 1 PC WAS SCRAPPED DUE TO THE PRODUCT BEING DROPPED ON THE FLOOR 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 SET SCREW 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 THE PATIENT WAS IMPLANTED WITH A CMF NAIL SYSTEM ON (B)(6) 2021. ONE DAY POST IMPLANTATION SURGERY, THE SURGEON CONFIRMED WITH RADIOLOGICAL IMAGING THAT THE LAG SCREW MIGRATED TOWARDS THE OUTER SIDE. THE PATIENT IS BEING MONITORED AND NO REVISION HAS BEEN PLANNED SO FAR. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING WITH A POTENTIAL CORRELATION TO THE REPORTED EVENT. THEREFORE, THE INVESTIGATION DID NOT IDENTIFY A NONCONFORMANCE OR A COMPLAINT OUT OF BOX (COOB). NEITHER X-RAYS, OPERATIVE NOTES, OFFICE VISIT NOTES, NOR DEVICES OR PHOTOS OF THE DEVICES WERE RECEIVED; HENCE VISUAL AND DIMENSIONAL EVALUATION COULD NOT BE PERFORMED; THEREFORE, THE CONDITION OF THE PARTS IS UNKNOWN. BASED ON THE INVESTIGATION AND DUE TO NO DOCUMENTATION BEING RECEIVED, THE REPORTED EVENT CAN NOT BE CONFIRMED. 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 (B)(4) 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 LAG SCREW IS SLIDING TO OUTER SIDE. THE SURGEON KEEPS AN EYE ON THE PATIENT CONDITION AS WELL AS NO REVISION IS PLANNED SO FAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1770304 Z NAIL CMF 10.5 X 95 LAG SCR TRAUMA LAG SCREW HWC ZIMMER SWITZERLAND MANUFACTURING GMBH N/A 3054641

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Hospitalization| R