BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN

    MDR report key: 6529120 · Received April 28, 2017

    Report

    Report Number
    0009613350-2017-00538
    Event Type
    Malfunction
    Date Received
    April 28, 2017
    Report Date
    April 28, 2017
    Manufacturer
    ZIMMER GMBH
    Product Code
    HWC
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AS FOR ZIMMER SPECIALISTS TO PERFORM AN IN-DEPTH ANALYSIS IT IS REQUIRED TO HAVE ALL NECESSARY INFORMATION AT HAND, IT WAS THEREFOR TRIED SEVERAL TIMES TO RECEIVE MORE INFORMATION FOR THIS CASE BUT IS CURRENTLY NOT AVAILABLE. AS NO LOT NUMBERS WERE PROVIDED FOR THE DEVICES, THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED. AN E-MAIL REQUESTING MISSING DEVICE DATA INFORMATION WAS SENT. AT ZIMMER GMBH 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 GMBH 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. NO TREND ANALYSIS COULD BE PERFORMED AS NO ITEM NUMBER IS AVAILABLE. EVENT SUMMARY: IT WAS REPORTED THAT A 1.8MM SCREW FROM THE MICROCAN SYSTEM STRIPPED DURING THE SURGERY. NO MEDICAL DATA SUCH AS X-RAYS, SURGICAL NOTES OR ANY OTHER CASE-RELEVANT DOCUMENTS RECEIVED. NO PRODUCT WAS RETURNED TO ZIMMER BIOMET FOR IN-DEPTH ANALYSIS. ROOT CAUSE DETERMINATION USING SAP RMW # (B)(4), REV 0: FAILURE OF SURGERY DUE TO USE OF THE DEVICE NOT COMPLAINT WITH DEFINED INDICATIONS - POSSIBLE, AS NO INFORMATION WAS PROVIDED THIS POINT CAN BE POSSIBLE. FAILURE OF SURGERY DUE TO WRONG SELECTION OF COMPONENTS OR USE IN COMBINATION WITH DEVICE OUTSIDE THE SYSTEM - POSSIBLE, IT IS POSSIBLE THAT WRONG SELECTION OF COMPONENTS WERE DONE OR A COMBINATION WITH A DEVICE OUTSIDE THE SYSTEM. SCREW SELECTION PROBLEMS DUE TO WRONG SCREW IS SELECTED - POSSIBLE, IT CAN BE THAT A WRONG SCREW WAS SELECTED. LINSCREW INSERTION PROBLEMS DUE TO USER SELECTS WRONG INSTRUMENTS AND/OR IMPLANTS - POSSIBLE, IT CAN BE THAT A WRONG SCREW/INSTRUMENT WAS SELECTED. SCREW INSERTION PROBLEMS DUE TO USER USED FOR THE APPLICATION OF THE SCREW UNSUITABLE GUIDING DEVICE - POSSIBLE, IT IS ALSO POSSIBLE THAT THE USER USED AN INCORRECT GUIDING DEVICE. CONCLUSION SUMMARY: NEITHER INTRA OPERATIVE X-RAYS, OPERATIVE NOTES OF THE IMPLANTATION, NOR DEVICES OR PHOTOS OF THE AFFECTED SCREW WERE RECEIVED; THEREFORE THE CONDITION OF THE COMPONENT IS UNKNOWN. NO REFERENCE OR LOT NUMBER WAS RECEIVED. SEVERAL ATTEMPTS WERE DONE FOR ADDITIONAL INFORMATION. NO SPECIFIC OR DETAILED INFORMATION WAS PROVIDED. IT CAN BE POSSIBLE THAT A WRONG SCREW/INSTRUMENT/GUIDING DEVICE WAS USED IN COMBINATION WITH THE SCREW. IN CONCLUSION, DUE TO SIGNIFICANT LACK OF INFORMATION, IT IS IMPOSSIBLE TO PERFORM A MEANINGFUL ANALYSIS OF THE REPORTED EVENT. THEREFORE, AN EXACT ROOT CAUSE CANNOT BE DETERMINED. THE NEED FOR CORRECTIVE MEASURES IS NOT INDICATED AND ZIMMER GMBH CONSIDERS THIS CASE AS CLOSED. ZIMMER¿S REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER DID NOT RECEIVE DEVICES, X-RAYS, OR OTHER SOURCE DOCUMENTS FOR REVIEW. AS NO LOT NUMBER WAS PROVIDED FOR THE DEVICES, THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED. ADDITIONAL INFORMATION WAS REQUESTED. 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).

    Description of Event or Problem · 1

    IT WAS REPORTED, THAT DURING SURGERY AN UNKNOWN 1.8MM SCREW STRIPPED (CATALOGUE AND LOT NUMBER OF THE SCREW ARE UNKNOWN). THIS IS THE ONLY INFORMATION RECEIVED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313250 UNKNOWN NA HWC ZIMMER GMBH N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1