BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CMN FEMORAL NAIL, CCD 135, RIGHT, 10 MM, 21.5 CM

    MDR report key: 8662369 · Received June 3, 2019

    Report

    Report Number
    0009613350-2019-00350
    Event Type
    Injury
    Date Received
    June 3, 2019
    Date of Event
    November 8, 2018
    Report Date
    June 17, 2020
    Manufacturer
    ZIMMER GMBH
    Product Code
    HSB
    UDI-DI
    00889024298996
    PMA / PMN Number
    K091566
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS WERE MADE AVAILABLE. TREND ANALYSIS: NO TREND HAS BEEN IDENTIFIED. EVENT DESCRIPTION: IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED WITH (B)(6) 2018 AND A FRACTURE WAS NOTED ON (B)(6) 2018. THE PATIENT REFUSED TO HAVE A REVISION SURGERY. REVIEW OF RECEIVED DATA: - TWO X-RAY PICTURES WERE RECEIVED. ONE X-RAY SHOWS AN IMPLANTED ZNN NAILING SYSTEM. IT CAN BE ASSUMED THAT THE X-RAY WAS TAKEN AFTER THE SURGERY. THE OTHER X-RAY IS DISPLAYED ON A SCREEN. THEREFORE, THE QUALITY OF THE X-RAY AND ITS REVIEW ARE VERY LIMITED. THE AXIS OF THE PROXIMAL PART OF THE ZNN NAIL (PART ABOVE THE LAG SCREW) DOES NOT SEEM TO BE ALIGNED WITH THE AXIS OF THE DISTAL PART OF THE ZNN NAIL WHICH COULD INDICATE A FRACTURE. HOWEVER, WITH ONLY ONE VIEW AT HAND THE POSITION OF THE PROXIMAL PART CANNOT BE FULLY EVALUATED (2D VS 3D). DEVICES ANALYSIS: - NO PRODUCT WAS RETURNED TO ZIMMER BIOMET FOR IN-DEPTH ANALYSIS AS THE DEVICE REMAINS IMPLANTED. REVIEW OF PRODUCT DOCUMENTATION: - ALL INVOLVED DEVICES ARE INTENDED FOR TREATMENT. - DHR REVIEW: THE QUALITY RECORDS SHOW THAT ALL SPECIFIED CHARACTERISTICS (MATERIAL, DIMENSIONS, SURFACE, ETC.) HAVE MET THE SPECIFICATIONS VALID AT THE TIME OF PRODUCTION. - RAW MATERIAL CERTIFICATE REVIEWED ON 04-JUN-2020 ARE ACCORDING TO SPECIFICATION. CONCLUSION SUMMARY: IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED WITH (B)(6) 2018 AND A FRACTURE WAS NOTED ON (B)(6) 2018. THE PATIENT REFUSED TO HAVE A REVISION SURGERY. THE QUALITY RECORDS SHOW THAT ALL SPECIFIED CHARACTERISTICS (MATERIAL, DIMENSIONS, SURFACE, ETC.) FOR THE ZNN NAIL HAVE MET THE SPECIFICATIONS VALID AT THE TIME OF PRODUCTION. NO PRODUCT WAS RETURNED TO ZIMMER BIOMET FOR IN-DEPTH ANALYSIS. THEREFORE, THE CONDITION OF THE COMPONENT IS UNKNOWN. THERE ARE SEVERAL FACTORS WHICH MAY HAVE CONTRIBUTED TO THE NAIL BREAKAGE. IT CAN BE THE NAIL WAS OVERSTRESSED DURING THE IN VIVO TIME OR A WRONG PATIENT BEHAVIOUR CAN ALSO BE THE CAUSE FOR THE BREAKAGE THE INVESTIGATION RESULTS DID NOT IDENTIFY A NON-CONFORMANCE OR A COMPLAINT OUT OF BOX (COOB). HOWEVER, BASED ON THE AVAILABLE INFORMATION AND PERFORMED INVESTIGATION, AN EXACT ROOT CAUSE FOR THE NAIL BREAKAGE COULD NOT BE DETERMINED. THE NEED FOR CORRECTIVE MEASURES IS NOT INDICATED AND ZIMMER 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: 0009613350-2019-00351-1.

    Description of Event or Problem · 0

    INVESTIGATION COMPLETED.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCT: ITEM # 00248511010, ITEM NAME ZNN CMN LAG SCREW, 10.5 MM, 110 MM, LOT# 2925635; ITEM # 47249300000, ITEM NAME SET SCREW, 8 MM, 21 MM, HEX 3.5 MM, 110 MM, LOT# 1643926N1; ITEM # 47248403550, ITEM NAME 5.0 MM DIAMETER CORTICAL SCREW - RED FIXED ANGLE 3.5 MM HEX HEAD, LOT# 63791250; ITEM # 47248700200, ITEM NAME CEPHALOMEDULLARY NAIL CAP 0 MM HEIGHT, LOT# 63864778. THE MANUFACTURER RECEIVED X-RAYS FOR REVIEW. THE DEVICE HAS NOT BEEN RECEIVED FOR INVESTIGATION AS THE PATIENT HAS NOT BEEN REVISED. THE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE. 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

    IT WAS REPORTED THAT PATIENT WAS IMPLANTED IN (B)(6) 2018 AND A FRACTURE ON THE IMPLANTED DEVICE WAS NOTICED ON (B)(6) 2018. REVISION SURGERY SCHEDULED ON UNKNOWN DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    457578 CMN FEMORAL NAIL, CCD 135, RIGHT, 10 MM, 21.5 CM ZIMMER NATURAL NAIL SYSTEM CEPHALOMEDULLARY NAILS HSB ZIMMER GMBH N/A 2747315 00889024298996

    Patients

    Seq Age Sex Outcome Treatment
    1 Other