BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANKLE FIX COMPRESSION/DISTRACTION INSTRUMENT

    MDR report key: 7600310 · Received June 14, 2018

    Report

    Report Number
    0009613350-2018-00622
    Event Type
    Malfunction
    Date Received
    June 14, 2018
    Date of Event
    May 23, 2018
    Report Date
    November 16, 2018
    Manufacturer
    ZIMMER GMBH
    Product Code
    HTY
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    DHR-REVIEW: NORMED MEDIZIN-TECHNIK GMBH IS A MEDICAL DEVICE COMPANY LOCATED IN TUTTLINGEN, GERMANY. NORMED MAINTAINS A QUALITY MANAGEMENT SYSTEM FOR DESIGN, MANUFACTURE AND FINAL INSPECTION OF THE RESPECTIVE DEVICES /DEVICE CATEGORIES IN ACCORDANCE WITH MDD ANNEX II AND WHICH FULFILS THE REQUIREMENTS OF ISO (B)(4). DURING THE FINAL INSPECTION OF PRODUCTS AT NORMED, THE INSPECTION OF EACH BATCH WAS PERFORMED ACCORDING TO ESTABLISHED INSPECTION PLANS. ONLY IF ALL INSPECTION CHARACTERISTICS PASSED THE FINAL INSPECTION, THE RELEASE TO MARKET WAS GRANTED AND THE PRODUCTS WERE TRANSFERRED FROM THE QUARANTINE AREA TO THE WAREHOUSE. IF A NON-CONFORMITY WAS DETECTED THE AFFECTED PARTS WERE EITHER REWORKED, SCRAPPED OR ¿ IF POSSIBLE ¿ A CONCESSION WAS GRANTED. THEREFORE IT CAN BE CONCLUDED THAT THE RELEASED COMPONENTS MET ALL REQUIREMENTS TO PERFORM AS INTENDED. TREND ANALYSIS: NO TREND CONSIDERING THE FOLLOWING EVENT IS IDENTIFIED: MISSING INSTRUMENT. EVENT DESCRIPTION: IT WAS REPORTED THAT THE PIN, WHICH IS USED WITH THE COMPRESSION DEVICE, WAS MISSING IN THE KIT. DEVICES ANALYSIS: VISUAL EXAMINATION: THE COMPRESSION DEVICE OF REF (B)(4) WAS RETURNED FOR AN INVESTIGATION. A FEW SIGNS OF USAGE ARE VISIBLE. OTHERWISE, THE COMPRESSION DEVICE SEEMS TO BE FULLY FUNCTIONAL. CONCLUSION SUMMARY: IT WAS REPORTED THAT THE PIN, WHICH IS USED WITH THE COMPRESSION DEVICE, WAS MISSING IN THE KIT. THIS ISSUE IS NOT ADDRESS ANY PRODUCT ISSUE OR MALFUNCTION. IT ADDRESSES A SUPPLY CHAIN MATTER. ACCORDING TO THE INFORMATION RECEIVED FROM THE WAREHOUSE IN BRIDGEND, THE MISSING INSTRUMENT HAS BEEN DETECTED PRIOR TO SENDING THE KIT TO THE HOSPITAL. ACCORDING TO APPLICABLE PROCESS, THE SALES EXECUTIVE OR DEPUTY HAS BEEN INFORMED. MOREOVER IT WAS FOUND, THAT AT THE CURRENT POINT IN TIME (NOV 2018) THERE IS A SUFFICIENT STOCK OF THIS INSTRUMENT. THE NEED FOR CORRECTIVE MEASURES IS NOT INDICATED AND ZIMMER GMBH CONSIDERS THIS CASE AS CLOSED. (B)(4). THE FOLLOWING REPORTS ARE ASSOCIATED WITH THIS EVENT: 0009613350 - 2018 - 00623 - 1.

    Description of Event or Problem · 0

    NO NEW INFORMATION.

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER DID NOT RECEIVE THE DEVICE YET, HOWEVER IT IS INDICATED BY COMPLAINANT THAT IT WILL BE RETURNED FOR INVESTIGATION. THE MANUFACTURER DID NOT RECEIVE X-RAYS, OR OTHER SOURCE DOCUMENTS FOR REVIEW. 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). THE FOLLOWING REPORT IS ASSOCIATED WITH THIS EVENT: 0009613350-2018-00623.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ANKLE FUSION SURGERY UPON OPENING THE SET, THE PIN WITH SCREW HEAD WAS MISSING IN THE SET. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    442524 ANKLE FIX COMPRESSION/DISTRACTION INSTRUMENT HTY ZIMMER GMBH N/A 389B14

    Patients

    Seq Age Sex Outcome Treatment
    1 PIN, ITEM# 28.14.140, LOT# UNKNOWN