BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPACTOR, ø 36

    MDR report key: 6656178 · Received June 21, 2017

    Report

    Report Number
    0009613350-2017-00879
    Event Type
    Malfunction
    Date Received
    June 21, 2017
    Report Date
    June 21, 2017
    Manufacturer
    ZIMMER GMBH
    Product Code
    HWA
    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 X-RAYS, OR OTHER SOURCE DOCUMENTS FOR REVIEW. THE MANUFACTURER DID NOT RECEIVE YET THE DEVICE, HOWEVER IT IS INDICATED BY COMPLAINANT THAT IT WILL BE RETURNED FOR INVESTIGATION. AS NO LOT NUMBER WAS PROVIDED, THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED. 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. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IS CURRENTLY NOT AVAILABLE. ZIMMER BIOMET¿S REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY RECORDS (DHR): A DHR REVIEW FOR THIS DEVICE WAS NOT POSSIBLE; THE LOT NUMBER IS NOT AVAILABLE ON THE RETURNED DEVICE. THE MISSING INFORMATION WAS REQUESTED AT COMPLAINANT, THE LATEST ONE ON (B)(6) 2017. 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. TREND ANALYSIS: NO TREND CONSIDERING THE FOLLOWING EVENT WAS IDENTIFIED: FRACTURED IMPACTOR. REVIEW OF EVENT DESCRIPTION: IT WAS REPORTED THAT THE IMPACTOR WAS FOUND BROKEN IN THE TRAY. REVIEW OF RECEIVED DATA: NO MEDICAL DATA SUCH AS SURGICAL NOTES OR ANY OTHER CASE-RELEVANT DOCUMENTS WERE RECEIVED. DEVICES ANALYSIS VISUAL EXAMINATION: ONE PART OF THE BROKEN PLASTIC IMPACTOR WAS RETURNED FOR AN INVESTIGATION. THE LOT IS NOT AVAILABLE. THE BREAKAGE OCCURRED AT THE THREADS OF THE INSTRUMENT. MOREOVER, THERE ARE MANY SIGNS OF USAGE VISIBLE. NO OTHER CONSPICUOUSNESS FOUND. ROOT CAUSE ANALYSIS: ROOT CAUSE DETERMINATION USING RMW: INSTRUMENT BREAKS, DEFORMS, DIVERGES IMPAIRING ITS FUNCTION DUE TO INADEQUATE DESIGN FOR INTENDED PERFORMANCE => NOT POSSIBLE -> A SYSTEMATIC ISSUE WITH DESIGN WOULD HAVE BEEN DETECTED AS PART OF THE ISSUE EVALUATION ASSESSMENT. INSTRUMENT BREAKS, DEFORMS, DIVERGES IMPAIRING ITS FUNCTION DUE TO MECHANICAL PROPERTIES OF MATERIAL INSUFFICIENT => NOT POSSIBLE -> A SYSTEMATIC ISSUE WITH MATERIAL PROPERTIES WOULD HAVE BEEN DETECTED AS PART OF THE ISSUE EVALUATION ASSESSMENT. INSTRUMENT BREAKS DUE TO DEGRADATION OF MATERIAL DUE TO CLEANING AND STERILIZATION => POSSIBLE, AS IT CANNOT BE EXCLUDED BASED ON THE AVAILABLE INFORMATION. IT REMAINS UNKNOWN, HOW OFTEN THE IMPACTOR HAS BEEN STERILIZED. DAMAGED INSTRUMENTS, IMPLANTS, BODY OR WRONG OPERATIONAL STEP DUE TO SURGEON OR STAFF UNFAMILIAR WITH INSTRUMENT USAGE AND HANDLING => POSSIBLE, AS IT CANNOT BE EXCLUDED BASED ON THE AVAILABLE INFORMATION. A DETERIORATION IN FUNCTION AS A RESULT OF REPEATED USE IS POSSIBLE. DAMAGED INSTRUMENTS, IMPLANTS, BODY OR WRONG OPERATIONAL STEP DUE TO SURGEON OR STAFF UNFAMILIAR WITH INSTRUMENT USAGE AND HANDLING => POSSIBLE, AS IT CANNOT BE EXCLUDED BASED ON THE AVAILABLE INFORMATION. EXTRAORDINARY HIGH FORCES MIGHT HAVE BEEN APPLIED DURING SURGERY. INSTRUMENT BREAKS OR DEFORMS DUE TO OFF-LABEL / ABNORMAL-USE => POSSIBLE, AS IT CANNOT BE EXCLUDED BASED ON THE AVAILABLE INFORMATION. EXTRAORDINARY HIGH FORCES MIGHT HAVE BEEN APPLIED DURING SURGERY. CONCLUSION SUMMARY: THE BROKEN IMPACTOR WAS RETURNED FOR AN INVESTIGATION. IT MIGHT BE A POSSIBILITY THAT UNUSUAL HIGH IMPACT / TORQUE FORCES MIGHT HAVE OCCURED ON THE INSTRUMENT DURING SURGERY, LEADING TO THE BREAKAGE. ANOTHER POSSIBILITY IS THAT THE SETTING INSTRUMENT WAS SCREWED ON INCOMPLETELY OR AT AN ANGLE, RESULTING IN HIGH STRESS IN THE MATERIAL, WHICH COULD HAVE LED TO THE BREAKAGE. ADDITIONALLY THERE MIGHT HAVE BEEN AN AGING OF MATERIAL DUE TO CLEANING AND STERILIZATION. AS THE LOT IS NOT KNOWN, IT REMAINS UNKNOWN WHEN THE INSTRUMENT HAS BEEN MANUFACTURED AND HOW LONG IT WAS ON THE MARKET. DUE TO THE MANY SIGNS OF USAGE, IT CAN BE ASSUMED THAT THE INSTRUMENT HAS ALREADY BEEN IN USE MANY TIMES. HOWEVER, AN EXACT ROOT CAUSE COULD NOT BE DETERMINED. 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 · 1

    IT WAS REPORTED THAT IMPACTOR, ø 36 IN THE INSTRUMENT TRAY WAS DEFECTIVE. THE IMPLANTATION AND EXPLANTATION DATES ARE LEFT EMPTY AS THE DEVICE INVOLVED IN THIS COMPLAINT IS AN INSTRUMENT. HENCE, NO EXPIRATION DATE IS CAPTURED, FOR THE SAME REASON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    439330 IMPACTOR, ø 36 CEP HIP INSTRUMENTS HWA ZIMMER GMBH N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1