BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZNN, CMN LAG SCREW, 10.5 MM, 105 MM INCLUDING SET SCREW

    MDR report key: 9966393 · Received April 16, 2020

    Report

    Report Number
    0009613350-2020-00193
    Event Type
    Injury
    Date Received
    April 16, 2020
    Date of Event
    March 22, 2020
    Report Date
    December 29, 2020
    Manufacturer
    ZIMMER SWITZERLAND MANUFACTURING GMBH
    Product Code
    HSB
    UDI-DI
    00889024298460
    PMA / PMN Number
    K091566
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    EVENT DESCRIPTION: IT WAS REPORTED THAT DURING SURGERY ON (B)(6) 2020, ALL THE INSTRUMENTATION HAD BEEN CHECKED AND THE ANGLE CHOSEN FOR THE NAIL WAS GOOD. DESPITE THIS, THE SCREW GOT STUCK IN THE NAIL AND SURGEON WAS UNABLE TO REMOVE IT BECAUSE THE CAMS WERE BROKEN. REVISION SURGERY IS RE-SCHEDULED TO REMOVE THE IMPLANT. REVIEW OF RECEIVED DATA: X-RAYS: ONE INTRA-OPERATIVE X-RAY PICTURE WAS RECEIVED. THE X-RAY WAS REVIEWED BY A HEALTHCARE PROFESSIONAL. THE QUALITY OF THE RECEIVED X-RAY IS VERY POOR SO A CLEAR STATEMENT ABOUT THE LAG SCREW FRACTURE CANNOT BE DONE. PRODUCT EVALUATION: NO PRODUCT WAS RETURNED; THEREFORE, VISUAL AND DIMENSIONAL EVALUATION COULD NOT BE PERFORMED. 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. SURGICAL TECHNIQUE: THE CORRECT LAG SCREW PLACEMENT IS DESCRIBED IN THE ZIMMER NATURAL NAIL SYSTEM ¿ CEPHALOMEDULLARY STANDARD SURGICAL TECHNIQUE. CONCLUSION: IT WAS REPORTED THAT DURING SURGERY ON (B)(6) 2020, ALL THE INSTRUMENTATION HAD BEEN CHECKED AND THE ANGLE CHOSEN FOR THE NAIL WAS GOOD. DESPITE THIS, THE SCREW GOT STUCK IN THE NAIL AND SURGEON WAS UNABLE TO REMOVE IT BECAUSE THE CAMS WERE BROKEN. REVISION SURGERY IS RE-SCHEDULED TO REMOVE THE IMPLANT. THE LAG SCREW WAS NOT RETURNED FOR INVESTIGATION. THE CORRECT LAG SCREW REMOVAL IS DESCRIBED IN THE ZIMMER NATURAL NAIL SYSTEM ¿ CEPHALOMEDULLARY STANDARD SURGICAL TECHNIQUE. IF THE LAG SCREW CAMS WERE SHEARED OFF, IT CAN BE ASSUMED THAT THIS OCCURRED DUE TO AN OVERLOAD ON THE CAMS. POSSIBLE CAUSES FOR THE OVERLOAD COULD BE: UNFAVORABLE PLACEMENT BETWEEN THE INSTRUMENT AND THE IMPLANT SO THEIR CONTACT SURFACE IS TOO SMALL, TOO HIGH FORCES WILL BE TRANSMITTED ON THE CAMS WHICH LEAD TO A FRACTURE OF THIS SECTION. THE CORRECT LAG SCREW PLACEMENT IS DESCRIBED IN THE ZIMMER NATURAL NAIL SYSTEM ¿ CEPHALOMEDULLARY STANDARD SURGICAL TECHNIQUE. PATHOGENIC BONE DISEASES (E.G. BONE TUMOR) WHICH CAN AFFECT MECHANICAL PROPERTIES OF THE BONE (HARDER/ DENSER BONE SUBSTANCE). THIS COULD ALSO LEAD TO HIGHER FORCES OF THESE SECTIONS. HOWEVER, BASED ON THE GIVEN INFORMATION AND THE RESULTS OF THE INVESTIGATION, THE COMPLAINT COULD NOT BE CONFIRMED AS THE ALLEGED FAILURE COULD NOT BE IDENTIFIED OR REPRODUCED. THE INVESTIGATION 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

    INVESTIGATION RESULT IS AVAILABLE NOW.

    Additional Manufacturer Narrative · 1

    MEDICAL PRODUCTS: CMN FEMORAL NAIL, CCD 125, LEFT, 11.5 MM, 21.5 CM; CATALOG#: 47249321111; LOT#: 3000494. THERAPY DATE: UNKNOWN. THE MANUFACTURER RECEIVED X-RAYS AND OTHER SOURCE DOCUMENTS FOR REVIEW. 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

    DURING SURGERY, ALL THE INSTRUMENTATION HAD BEEN CHECKED AND THE ANGLE CHOSEN FOR THE NAIL WAS GOOD. DESPITE THIS, THE SCREW GOT STUCK IN THE NAIL AND SURGEON WAS UNABLE TO REMOVE IT BECAUSE THE FINS WERE BROKEN. REVISION SURGERY IS RE-SCHEDULED TO REMOVE THE IMPLANT. SURGICAL DELAY OF ONE HOUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    431645 ZNN, CMN LAG SCREW, 10.5 MM, 105 MM INCLUDING SET SCREW ZIMMER NATURAL NAIL SYSTEM CEPHALOMEDULLARY NAILS HSB ZIMMER SWITZERLAND MANUFACTURING GMBH N/A 3008697 00889024298460

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization