BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPINDLE FOR EVOLUTION

    MDR report key: 10605881 · Received September 30, 2020

    Report

    Report Number
    8030965-2020-07536
    Event Type
    Malfunction
    Date Received
    September 30, 2020
    Report Date
    September 29, 2020
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    LXH
    UDI-DI
    07611819542303
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PART NUMBER: 03.825.002, SYNTHES LOT NUMBER: H052900, SUPPLIER LOT NUMBER: N/A, RELEASE TO WAREHOUSE DATE: 13JUL2016, EXPIRATION DATE: N/A, SUPPLIER: (B)(4). NO NCRS WERE GENERATED DURING PRODUCTION. VISUAL INSPECTION: UPON VISUAL INSPECTION, IT WAS OBSERVED THAT THE WELD CONNECTING THE KNOB WITH THE SPINDLE WAS BROKEN DUE TO WHICH THE KNOB IS ABLE TO ROTATE AND DISASSEMBLE FROM THE SPINDLE. MOREOVER, THERE ARE HEAVY SIGNS OF USE, SUCH AS SCRATCHES AND MARKS VISIBLE ON THE ENTIRE SURFACE. THE OBSERVED DAMAGE IS CONSISTENT WITH THE REPORTED COMPLAINT CONDITION AS SUCH THE COMPLAINT CONDITION CAN BE CONFIRMED. ALL FEATURES RELATED TO THE REPORTED COMPLAINT CONDITION WERE REVIEWED AND NO OTHER ISSUES WERE IDENTIFIED. DIMENSIONAL INSPECTION: PART: SPINDLE, FEATURE: OUTER DIAMETER (BESIDES BROKEN LASER WELD), RESULT: PASS. DOCUMENT/SPECIFICATION REVIEW: THE MANUFACTURING REVIEW SHOWS THAT THE PRODUCTION PROCEDURE WAS ACCORDING TO THE SPECIFICATIONS AND THERE WERE NO ISSUES THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. INVESTIGATION CONCLUSION: OUR INVESTIGATION HAS SHOWN THAT THE COMPLAINT CONDITION IS CONFIRMED DUE TO THE RECEIVED CONDITION OF THE DEVICE. THE MICROSCOPIC OBSERVATION SHOWS REMAINING LASER WELDS ON BOTH INVOLVED COMPONENTS SHOWING THAT THE WELD JOINT WAS CORRECT AT THE TIME OF MANUFACTURING. THE FOR THE COMPLAINT RELEVANT DIMENSIONS WERE CHECKED AS FAR AS POSSIBLE AND FOUND TO BE WITHIN SPECIFICATIONS. WE DO SUPPOSE THAT THE DEVICE ENCOUNTERED UNINTENDED FORCES, SUCH AS EXCESSIVE FORCE APPLICATION DURING ITS USE, WHICH FINALLY RESULTED IN THE BREAKAGE. DURING THE INVESTIGATION, NO PRODUCT DESIGN OR MANUFACTURING ISSUES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION; THEREFORE, FURTHER CORRECTIVE AND/OR PREVENTIVE ACTION IS NOT REQUIRED. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST MARKET SAFETY SURVEILLANCE ACTIVITIES. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. 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 (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020 AFTER THE SURGERY THE HANDLE OF THE HAMMER WAS DISCOVERED TO BE LOOSE AND WOBBLY. THIS REPORT IS FOR ONE (1) SPINDLE FOR EVOLUTION. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1069996 SPINDLE FOR EVOLUTION ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH OBERDORF SYNTHES PRODUKTIONS GMBH H052900 07611819542303

    Patients

    Seq Age Sex Outcome Treatment
    1