BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SET SCREW, 8 MM, 21 MM, HEX 3.5 MM

    MDR report key: 8539355 · Received April 23, 2019

    Report

    Report Number
    0009613350-2019-00240
    Event Type
    Malfunction
    Date Received
    April 23, 2019
    Date of Event
    March 20, 2019
    Report Date
    February 14, 2020
    Manufacturer
    ZIMMER GMBH
    Product Code
    HSB
    UDI-DI
    00889024298620
    PMA / PMN Number
    K091566
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING FILLED TO RELAY INVESTIGATION RESULT. DHR REVIEW: THE DEVICE MANUFACTURING QUALITY RECORDS INDICATE THAT THE RELEASED COMPONENTS MET ALL REQUIREMENTS TO PERFORM AS INTENDED. TREND ANALYSIS: NO TREND IDENTIFIED. DEVICE ANALYSIS: VISUAL EXAMINATION: THE SET SCREW HAS BEEN RETURNED FOR INVESTIGATION. THE VISUAL EXAMINATION SHOWS THAT THE TIP OF THE SET SCREW IS PARTIALLY BROKEN. THIS CAN BE CAUSED BY INCORRECT PLACEMENT OF THE SET SCREW INTO THE LAG SCREW GROOVES. 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).

    Description of Event or Problem · 0

    PLEASE REFER TO REPORT 0009613350-2019-00240.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: ITEM# 47-2493-000-00, LOT# 4502405237, SET SCREW, 8 MM, 21MM, HEX 3.5 MM, ITEM# 47-2485-095-10, LOT# 2962002, ZNN, CMN LAG SCREW, 10.5 MM, 95 MM, INCLUDING SET SCREW, ITEM# 47-2493-210-13, LOT# 2938084, Z NAIL CPM 13MMX21.5CM 125 R. THE COMPLAINT DEVICE (ITEM# 47-2493-000-00) HAS BEEN RETURNED, BUT THE DEVICE INVESTIGATION HAS NOT YET BEEN COMPLETED. ONCE THE EVALUATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED. THE MANUFACTURER DID NOT RECEIVE OTHER SOURCE DOCUMENTS FOR REVIEW. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. THE FOLLOWING REPORTS ARE ASSOCIATED WITH THIS EVENT: 0009613350-2019 -00241 AND 0009613350-2019-00242. A CAUSE FOR THIS SPECIFIC EVENT CANNOT BE ASCERTAINED AS THE INVESTIGATION HAS NOT YET COMPLETED. AS SOON AS SUPPLEMENTAL INFORMATION OR INVESTIGATION RESULT BECOMES AVAILABLE AN UPDATED REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, DURING THE INITIAL SURGERY, THERE WAS AN ASSEMBLING PROBLEM WITH THE SET SCREW TO THE LAG SCREW. IT WAS STATED THAT THE TIP OF THE SET SCREW WAS FRACTURED. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    333864 SET SCREW, 8 MM, 21 MM, HEX 3.5 MM ZIMMER NATURAL NAIL SYSTEM CEPHALOMEDULLARY NAILS HSB ZIMMER GMBH N/A 4502405237 00889024298620

    Patients

    Seq Age Sex Outcome Treatment
    1