BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPINDLE FOR EVOLUTION

    MDR report key: 9595689 · Received January 16, 2020

    Report

    Report Number
    8030965-2020-00393
    Event Type
    Malfunction
    Date Received
    January 16, 2020
    Report Date
    December 19, 2019
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    LXH
    UDI-DI
    07611819542303
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. VISUAL INSPECTION: THE SYNCAGE EVOLUTION SPINDLE (P/N:03.825.002, LOT #: H143326) WAS RETURNED AND RECEIVED AT US CQ. UPON VISUAL INSPECTION, IT WAS OBSERVED THAT THE WELD CONNECTING THE KNOB WITH THE SPINDLE WAS BROKEN ALLOWING THE KNOB TO ROTATE AND DISASSEMBLE FROM THE SPINDLE. THERE WERE SCRATCHES ON THE DEVICE BUT HAS NO IMPACT ON THE FUNCTIONALITY OF THE DEVICE. DEVICE FAILURE/DEFECT IDENTIFIED? YES. DIMENSIONAL INSPECTION: THE DIMENSIONAL INSPECTION WAS PERFORMED ON THE RETURNED DEVICE. DOCUMENT/SPECIFICATION REVIEW BASED ON THE DATE OF MANUFACTURE THE DRAWINGS REFLECTING THE CURRENT AND MANUFACTURED REVISION WERE REVIEWED . COMPLAINT CONFIRMED? YES, THE DEVICE RECEIVED WAS BROKEN. HENCE CONFIRMING THE ALLEGATION. INVESTIGATION CONCLUSION THE COMPLAINT CONDITION IS CONFIRMED FOR THE SYNCAGE EVOLUTION SPINDLE (P/N:03.825.002, LOT #: H143326). THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE ISSUE AND HENCE THE ROOT CAUSE CANNOT BE DETERMINED. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST MARKET SAFETY SURVEILLANCE ACTIVITIES. DEVICE HISTORY LOT MANUFACTURING LOCATION: SUPPLIER - (B)(4) AND RELEASED BY: MONUMENT RELEASE TO WAREHOUSE DATE: OCT 28, 2016, PART NUMBER: 03.825.002, SPINDLE FOR EVOLUTION, LOT NUMBER: H143326 (NON-STERILE), LOT QUANTITY: 26. WORK ORDER TRAVELER MET ALL INSPECTION ACCEPTANCE CRITERIA. INSPECTION SHEET, INCOMING FINAL INSPECTION NS069512 REV C MET ALL INSPECTION ACCEPTANCE CRITERIA. CERTIFICATE OF COMPLIANCE RECEIVED FROM AVALIGN DATED OCT 07, 2016 WAS REVIEWED AND DETERMINED TO BE CONFORMING. PACKAGING LABEL LOG LPPF, LMD/LPF REV AA WAS REVIEWED AND DETERMINED TO BE CONFORMING. THIS LOT MET ALL DIMENSIONAL, VISUAL AND PACKAGING CRITERIA AT THE TIME OF RELEASE WITH NO ISSUES DOCUMENTED DURING THE INSPECTION OR RELEASE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. DEC 27, 2019: DHR REVIEWED: THIS LOT MET ALL DIMENSIONAL, VISUAL AND PACKAGING CRITERIA AT THE TIME OF RELEASE WITH NO ISSUES DOCUMENTED DURING THE INSPECTION OR RELEASE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. REPORTER IS A COMPANY REPRESENTATIVE. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED DURING INSPECTION OF DEVICES AT THE STORAGE FACILITY THE WELDING SEAM FROM HEAD TO SHAFT IS BROKEN OFF TWO (2) SYNCAGE SPINDLE INSTRUMENTS. THE HEAD CAN NOW BE MOVED AND TURNED WHICH LEAVES THE DEVICES NONFUNCTIONAL. THERE WAS NO PATIENT INVOLVEMENT THIS IS REPORT 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    58309 SPINDLE FOR EVOLUTION MISC ORTHO SURGICAL INSTR LXH OBERDORF SYNTHES PRODUKTIONS GMBH H143326 07611819542303

    Patients

    Seq Age Sex Outcome Treatment
    1