BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXTRACTOR WITH SLIDING HAMMER

    MDR report key: 5672647 · Received May 23, 2016

    Report

    Report Number
    0009613350-2016-00716
    Event Type
    Malfunction
    Date Received
    May 23, 2016
    Date of Event
    April 27, 2016
    Report Date
    April 29, 2016
    Manufacturer
    ZIMMER GMBH
    Product Code
    HWB
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER DID NOT RECEIVE THE DEVICE OR OTHER SOURCE DOCUMENTS FOR REVIEW. WHERE LOT NUMBERS WERE RECEIVED FOR THE DEVICE, THE DEVICE HISTORY RECORDS WAS REVIEWED AND FOUND TO BE CONFORMING. A CAUSE FOR THIS SPECIFIC EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE AND AN INVESTIGATION RESULT BE AVAILABLE, THAT CHANGES THIS ASSESSMENT, AN AMENDED MEDICAL DEVICE REPORT WILL BE SUBMITTED. ZIMMER¿S REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Additional Manufacturer Narrative · 1

    INVESTIGATION RESULTS WERE MADE AVAILABLE. DEVICE HISTORY RECORDS (DHR): REF: 01.06808.300, LOT: 4023378. THE DEVICE MANUFACTURING QUALITY RECORDS INDICATE THAT THE RELEASED COMPONENTS MET ALL REQUIREMENTS TO PERFORM AS INTENDED. TREND ANALYSIS: NO TREND WAS IDENTIFIED. REVIEW OF EVENT DESCRIPTION: IT WAS REPORTED THAT THE MOUNTING THREAD WAS DEFECTIVE AND THAT THE IMPACTOR COULD NOT BE FIXED TO THE IMPLANT. REVIEW OF RECEIVED DATA: NO MEDICAL DATA SUCH AS X-RAYS, SURGICAL NOTES OR ANY OTHER CASE-RELEVANT DOCUMENTS WERE RECEIVED. DEVICES ANALYSIS: VISUAL EXAMINATION: THE THREAD IS COMPLETELY DAMAGED AND CANNOT BE USED ANYMORE. ROOT CAUSE DETERMINATION USING RISK MANAGEMENT WORKSHEET: INSTRUMENT BREAKS, DEFORMS, DIVERGES IMPAIRING ITS FUNCTION DUE TO INADEQUATE DESIGN FOR INTENDED PERFORMANCE: NOT POSSIBLE: A DESIGN ISSUE WOULD HAVE BEEN DETECTED DURING THE TRENDING PROCEDURE; INSTRUMENT BREAKS, DEFORMS, DIVERGES IMPAIRING ITS FUNCTION DUE TO MECHANICAL PROPERTIES OF MATERIAL INSUFFICIENT: NOT POSSIBLE: A MATERIAL ISSUE WOULD HAVE BEEN DETECTED DURING THE TRENDING PROCEDURE. INADEQUATE USABILITY OF INSTRUMENT DUE TO INADEQUATE DESIGN FOR INTENDED HANDLING PERFORMANCE: NOT POSSIBLE: A DESIGN ISSUE WOULD HAVE BEEN DETECTED DURING THE TRENDING PROCEDURE; INSTRUMENT BREAKS OR DEFORMS DUE TO OFF-LABEL / ABNORMAL-USE: POSSIBLE, THE THREAD IS COMPLETELY DAMAGED AND THE DEVICE CANNOT BE USED ANYMORE. IT IS NOT DESCRIBED HOW THE DEVICE WAS USED; INSTRUMENT CANNOT BE USED WITH THE CONNECTED INSTRUMENT AS INTENDED DUE TO FAILURE OF INSTRUMENT ASSEMBLY CONDITION: POSSIBLE, THE THREAD IS COMPLETELY DAMAGED AND THE DEVICE CANNOT BE USED ANYMORE. IT IS NOT DESCRIBED HOW THE DEVICE WAS USED. CONCLUSION SUMMARY: THERE ARE SEVERAL CONDITIONS THAT MIGHT HAVE CONTRIBUTED TO THIS FAILURE, E.G.: CONTAMINATED THREAD BY FOREIGN PARTICLES OR SUBSTANCES CAN CHANGE THE FORCE DISTRIBUTION; LOADS IN NOT ONLY AXIAL DIRECTION ALSO CHANGE THE LOAD DISTRIBUTION ON THE THREAD; IF THE THREAD IS NOT FULLY TIGHTENED, THERE IS SOME CLEARANCE AND NOT ALL THREAD TURNS ARE LOADED. HOWEVER, AN EXACT ROOT CAUSE COULD NOT BE DETERMINED. THE NEED FOR CORRECTIVE MEASURES IS NOT INDICATED AND ZIMMER (B)(4) CONSIDERS THIS CASE AS CLOSED. ZIMMER'S REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE EXTRACTOR COULD NOT BE FIXED TO THE IMPLANT. FURTHER INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    326960 EXTRACTOR WITH SLIDING HAMMER EXTRACTOR WITH SLIDING HAMMER HWB ZIMMER GMBH N/A 4023378

    Patients

    Seq Age Sex Outcome Treatment
    1