BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AWL

    MDR report key: 6029496 · Received October 14, 2016

    Report

    Report Number
    0009613350-2016-01265
    Event Type
    Malfunction
    Date Received
    October 14, 2016
    Date of Event
    September 20, 2016
    Report Date
    September 23, 2016
    Manufacturer
    ZIMMER GMBH
    Product Code
    HWJ
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER DID NOT RECEIVE THE DEVICE FOR REVIEW. X-RAY PICTURES WERE RECEIVED AND WILL BE REVIEWED WITHIN THE INVESTIGATION. A LOT NUMBER WAS RECEIVED FOR THE DEVICE, THE DEVICE HISTORY RECORDS WILL BE REVIEWED WITHIN THE INVESTIGATION. A CAUSE FOR THIS SPECIFIC EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED. AS SOON AS ADDITIONAL INFORMATION BECOME AVAILABLE AND/OR AN INVESTIGATION RESULT BE AVAILABLE, AN AMENDED MEDICAL DEVICE REPORT WILL BE SUBMITTED. (B)(4).

    Additional Manufacturer Narrative · 1

    A TECHNICAL INVESTIGATION WAS NOT POSSIBLE TO PERFORM, AS THE DEVICES WERE NOT AT HAND. HOWEVER, BASED ON THE AVAILABLE INFORMATION THE INVESTIGATION IS CONDUCTED WITH OUTCOME AS FOLLOWS. TREND ANALYSIS: NO TREND IDENTIFIED. DEVICE HISTORY RECORDS (DHR): AT ZIMMER (B)(4) ALL MEDICAL DEVICES PRIOR RELEASE TO MARKET UNDERGO SEVERAL QUALITY INSPECTIONS AS DEFINED IN OUR QUALITY PROCEDURES. OUR QUALITY INSPECTION- AND DEVIATION PROCEDURES ENSURE THAT ONLY PRODUCTS FULFILLING THE SPECIFICATION ARE SOLD. THESE PROCEDURES ARE PART OF THE OVERALL QUALITY MANAGEMENT SYSTEM AT ZIMMER (B)(4) AND GET REGULARLY AUDITED BY OUR NOTIFIED BODY, COMPETENT AUTHORITIES AND INTERNAL AND EXTERNAL AUDITORS. THUS, FOR ALL PRODUCTS SOLD TO THE MARKET CAN BE ASSUMED HAVING A COMPLETE AND CORRECT DHR. EVENT SUMMARY: IT IS REPORTED THAT THE "HANDAWL FOR REAMING MS 30" BROKE IN TWO PARTS, ONE PART IS LEFT IN THE PATIENT. REVIEW OF RECEIVED DATA: NO MEDICAL DATA SUCH AS X-RAYS, SURGICAL NOTES OR ANY OTHER CASE-RELEVANT DOCUMENTS RECEIVED. DEVICES ANALYSIS: NO PRODUCT WAS RETURNED TO ZIMMER BIOMET FOR IN-DEPTH ANALYSIS. REVIEW OF PRODUCT DOCUMENTATION: PARTS WERE 100% VISUALLY INSPECTED (IN THE YEAR 1998). CONCLUSION SUMMARY: CUTTING AND DRILLING INSTRUMENTS ARE CATEGORIZED AS ¿EXTERNAL COMMUNICATING DEVICES¿ WITH "TISSUE/BONE" CONTACT FOR LESS THAN 24 HOURS. DUE TO THE FACT THAT A PART OF THE INSTRUMENT STAYED IN THE BODY, PATIENT HAS TO BE MONITORED. THE INSTRUMENT WAS IN USE FOR AROUND 18 YEARS. THEREFORE THE MOST LIKELY ROOT CAUSE IS THAT THE FUNCTION OF THE BLADES WAS NOT GIVEN ANYMORE DUE TO LONG TERM USE / EXCESSIVE USE (WEAR). ADDITIONALLY, ACCORDING TO THE IFU: "IF DAMAGE OR WEAR IS NOTED THAT MAY COMPROMISE THE FUNCTION OF THE INSTRUMENT, DO NOT USE THE DEVICE AND CONTACT YOUR ZIMMER REPRESENTATIVE FOR REPLACEMENT." HOWEVER, AN EXACT ROOT CAUSE COULD NOT BE DETERMINED. THE NEED FOR CORRECTIVE ACTIONS IS NOT INDICATED AND ZIMMER (B)(4) CONSIDERS THIS CASE AS CLOSED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING SURGERY, THE AWL BROKE IN TWO. ONE PART WAS LEFT IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    683095 AWL AWL HWJ ZIMMER GMBH N/A 9207

    Patients

    Seq Age Sex Outcome Treatment
    1 Other