BEUDAMED
    FDA Adverse Event Injury Summary report: N

    Z NAIL CPM 11.5MM X 34CM 130 L

    MDR report key: 9573950 · Received January 10, 2020

    Report

    Report Number
    0009613350-2020-00020
    Event Type
    Injury
    Date Received
    January 10, 2020
    Date of Event
    December 11, 2019
    Report Date
    December 9, 2020
    Manufacturer
    ZIMMER SWITZERLAND MANUFACTURING GMBH
    Product Code
    HSB
    PMA / PMN Number
    K091566
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WHICH WAS RECEIVED ON JUL 30, 2020 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

    INVESTIGATION RESULTS WERE MADE AVAILABLE. EVENT DESCRIPTION: IT WAS REPORTED THAT THERE WAS A ZNN NAIL FRACTURE WHICH LED TO A REVISION SURGERY ON THE (B)(6) 2019. THE NAIL WAS IMPLANTED ON THE (B)(6) 2019. 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. XRAYS: SOME XRAYS HAVE BEEN PROVIDED WHICH SHOWS THE LEFT HIP OF THE PATIENT. THE NAIL BREAKAGE CANNOT BE SEEN IN THE XRAYS. SURGICAL REPORT: SEVERAL DOCUMENTS WERE RECEIVED IN FRENCH. THE SURGICAL REPORT OF REVISION DATED (B)(6) 2019 AND IMPLANTATION DATED (B)(6) 2019 HAVE BEEN REVIEWED. ADDITIONAL INFORMATION FOUND WHICH LED TO THE CREATION OF A NEW COMPLAINT (B)(4). THIS COMPLAINT HAS ALREADY BEEN REPORTED AND CLOSED. PRODUCT EVALUATION: VISUAL EXAMINATION: THE BROKEN ZNN NAIL WAS RETURNED FOR INVESTIGATION. THE NAIL WAS BROKEN INTO TWO FRAGMENTS. THE FRACTURE OF THE NAIL IS LOCATED THROUGH THE LAG SCREW HOLE. THE FRACTURE SURFACES SHOWS SMALL POLISHED AREAS AND SOME SCRATCHES, MOST PROBABLY DUE TO CONTACT BETWEEN THE PARTS AFTER THE FRACTURE. SEVERAL SCRATCHES ARE VISIBLE ON THE SURFACE OF THE NAIL. REVIEW OF PRODUCT DOCUMENTATION: DEVICE PURPOSE: THIS DEVICE IS INTENDED FOR TREATMENT. PRODUCT COMPATIBILITY: THE COMPATIBILITY CHECK WAS PERFORMED FROM WWW.PRODUCTCOMPATIBILITY.ZIMMER.COM AND SHOWED THAT THE PRODUCT COMBINATION WAS APPROVED BY ZIMMER BIOMET. DHR REVIEW: REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. RAW MATERIAL CERTIFICATE: THE RAW MATERIAL CERTIFICATE WAS REVIEWED WITH NO ANOMALIES NOTED. CONCLUSION: IT WAS REPORTED THAT THERE WAS A ZNN NAIL FRACTURE WHICH LED TO A REVISION SURGERY ON THE (B)(6) 2019. THE NAIL WAS IMPLANTED ON THE (B)(6) 2019. 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. THE VISUAL EXAMINATION OF THE NAIL SHOWS NO DEFECTS THAT COULD TRIGGER OR CONTRIBUTE TO THE FRACTURE. IT IS MOST POSSIBLE THAT THE NAIL WAS BROKEN DUE TO OVERLOAD. POSSIBLE CONTRIBUTING FACTORS TO THE OVERLOAD COULD BE A NOT PROPERLY HEALED BONE FRACTURE AND / OR NOT ADHERENCE TO THE POSTOPERATIVE PROTOCOL (PATIENT BEHAVIOR). HOWEVER, BASED ON THE AVAILABLE INFORMATION AND PERFORMED INVESTIGATION, AN EXACT ROOT CAUSE FOR THE NAIL BREAKAGE COULD NOT BE DETERMINED. THE INVESTIGATION RESULTS DID NOT IDENTIFY A NONCONFORMANCE OR A COMPLAINT OUT OF BOX (COOB). 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 PATIENT UNDERWENT REVISION SURGERY DUE TO IMPLANT FRACTURE.

    Description of Event or Problem · 0

    INVESTIGATION RESULTS ARE NOW AVAILABLE.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS AND THERAPY DATE DETAIL OF PRODUCT: ITEM NUMBER 47248509010, ITEM NAME ZNN, CMN LAG SCREW, 10.5 MM, 90 MM, INCLUDING SET SCREW, LOT # 2950596. THE MANUFACTURER RECEIVED X-RAYS AND OTHER SOURCE DOCUMENTS FOR REVIEW. THE MANUFACTURER DID NOT RECEIVE THE DEVICE FOR INVESTIGATION. AS NO LOT NUMBER WAS PROVIDED, THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED. 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. (B)(4). ITEM AND LOT NUMBERS UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT REVISION SURGERY DUE TO IMPLANT FRACTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    40459 Z NAIL CPM 11.5MM X 34CM 130 L ZIMMER NATURAL NAIL SYSTEM CEPHALOMEDULLARY NAILS HSB ZIMMER SWITZERLAND MANUFACTURING GMBH N/A 2969311

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R