BEUDAMED
    FDA Adverse Event Summary report: N

    DP VARIO SUB T SCR IMPSM SZ CANN BLU HDL

    MDR report key: 5059664 · Received September 7, 2015

    Report

    Report Number
    9613350-2015-01077
    Date Received
    September 7, 2015
    Date of Event
    August 10, 2015
    Report Date
    August 10, 2015
    Manufacturer
    NORMED MEDIZIN-TECHNIK GMBH
    Product Code
    LXH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER DID NOT RECEIVE THE INSTRUMENT OR SOURCE DOCUMENTS FOR REVIEW. WHERE LOT NUMBERS WERE RECEIVED FOR THE DEVICES, THE DEVICE HISTORY RECORDS WERE 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

    IT WAS REPORTED THAT BOTH DEVICES WERE BROKEN. NO FURTHER INFORMATION RECEIVED. DP VARIO DILL 70/100MM CANN BLU HDL, REF#: 29.07.010, LOT#: 145C13. THE DEVICE MANUFACTURING QUALITY RECORDS INDICATE THAT THE RELEASED COMPONENTS MET ALL REQUIREMENTS TO PERFORM AS INTENDED. DP VARIO SUB T SCR IMPSM SZ CANN BLU HDL, REF#:29.09.100, LOT#:145C14, THE DEVICE MANUFACTURING QUALITY RECORDS INDICATE THAT THE RELEASED COMPONENTS MET ALL REQUIREMENTS TO PERFORM AS INTENDED. NO TREND IDENTIFIED. THE COMPATIBILITY CHECK WAS PERFORMED AND SHOWED THAT THE PRODUCT COMBINATION WAS APPROVED BY ZIMMER. WE RECEIVED BOTH DEVICES FOR INVESTIGATION. THE VISUAL EXAMINATION OF THE DEVICE REF# 29.07.010 SHOWED THAT THE PROXIMAL PART (CONE) WAS BROKEN ON THE SHAFT. THIS PART WAS BROKEN ON THE WELDING AREA. THE VISUAL EXAMINATION OF THE DEVICE REF# 29.09.100 SHOWED THAT THE HOOK WAS DAMAGED AND BENT. FURTHERMORE, THE TWO WIRES ON THE HOOK WERE ALSO BROKEN ON THE WELDING FIXATION. THE ENDPIECE OF THE IMPACTOR DID NOT SHOW ANY DEFORMATION. POSSIBLE CAUSES FOR THE REPORTED EVENT ACCORDING TO DFMEA: A. FRACTURE OF INSTRUMENT DUE TO DEGRADATION OF MATERIAL DUE TO CLEANING AND STERILIZATION. B. FRACTURE OF INSTRUMENT DUE TO GENERAL CORROSION (CREVICE, PITTING, GALVANIC). C. DAMAGED INSTRUMENTS, IMPLANTS, BODY OR WRONG OPERATIONAL STEP DUE TO SURGEON OR STAFF UNFAMILIAR WITH INSTRUMENT USAGE AND HANDLING. D. INSTRUMENT BROKE OR DEFORMED DUE TO OFF-LABEL / ABNORMAL-USE. COMPARISON TO INVESTIGATION RESULTS WHETHER IT IS POSSIBLE AND JUSTIFICATION: A. POSSIBLE: IT IS POSSIBLE THAT THE DEVICES WERE BROKEN DURING CLEANING AND STERILIZATION. MAYBE IT WAS ALSO POSSIBLE THAT THE DEVICE WERE MISHANDLED DURING CLEANING AND THEREFORE LEAD TO THE BREAKAGE. B. NOT POSSIBLE: NO CORROSION FOUND DURING INVESTIGATION. C. POSSIBLE: IT IS MOST POSSIBLE THAT THE USER WAS UNFAMILIAR WITH THE DEVICES AND MISHANDLED THEM WHILE USING. D. POSSIBLE: AN OFF LABEL IS ALSO POSSIBLE AS NO FURTHER INFORMATION WAS PROVIDED HOW THE USER DID HANDLE THE DEVICES. BASED ON THE GIVEN INFORMATION AND THE RESULTS OF THE INVESTIGATION, WE WERE NOT ABLE TO IDENTIFY A SPECIFIC ROOT CAUSE FOR THIS ISSUE. THE NEED FOR CORRECTIVE ACTIONS 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 SURGEON WAS USING A DP VARIO SUB T SCR IMPSM SZ CANN BLU HDL AND THAT THE INSTRUMENT BROKE. AT THE TIME OF THIS REPORT NO OTHER INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    591040 DP VARIO SUB T SCR IMPSM SZ CANN BLU HDL NORMED VARIO SUBTALAR LXH NORMED MEDIZIN-TECHNIK GMBH NA 145C14

    Patients

    Seq Age Sex Outcome Treatment
    1 Other