BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCAGE EVOLUTION SPINDLE

    MDR report key: 9198463 · Received October 16, 2019

    Report

    Report Number
    8030965-2019-69373
    Event Type
    Malfunction
    Date Received
    October 16, 2019
    Report Date
    September 23, 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
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION FLOW: DAMAGE. VISUAL INSPECTION: THE SYNCAGE EVOLUTION SPINDLE (PART # 03.825.002 LOT # H052900) WAS RECEIVED AT US CQ. UPON MAGNIFICATION, THE WELD THAT JOINS THE SHAFT AND THE KNOB HAS A HAIRLINE CRACK ALONG THE ENTIRE CIRCUMFERENCE OF THE WELD. THE KNOB CAN TOGGLE SLIGHTLY WHEN APPLYING ROTATIONAL FORCE, THE SHAFT CANNOT BE SEPARATED FROM THE KNOB. THERE ARE SURFACE SCRATCHES ALONG THE SHAFT OF THE DEVICE THAT ARE CONSISTENT WITH NORMAL WEAR. THE RECEIVED CONDITION IS CONSISTENT WITH THE COMPLAINT CONDITION THUS THE COMPLAINT IS CONFIRMED DEVICE FAILURE/DEFECT IDENTIFIED? YES; WELD FAILURE. DIMENSIONAL INSPECTION: SHAFT DIAMETER JUST PROXIMAL TO THE WELD WAS MEASURED. SPECIFIED DIMENSIONS SHAFT DIAMETER = 6.2MM +/- 0.05. MEASURED DIMENSIONS: SHAFT DIAMETER = 6.20MM; CONFORMING. MANUFACTURING RECORD EVALUATION: THE RECEIVED SYNCAGE EVOLUTION SPINDLE (PART # 03.825.002, LOT # H052900) WAS MANUFACTURED AT AVALIGN TECHNOLOGIES ¿ (B)(4) ON (B)(6) 2016. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. CONCLUSION: THE COMPLAINT WAS CONFIRMED FOR THE RECEIVED SYNCAGE EVOLUTION SPINDLE (PART # 03.825.002, LOT # H052900) AS THE WELD FAILED. THE WELD IS CRACKED ALONG ITS ENTIRE CIRCUMFERENCE WHICH RESULTED IN A LOOSE SHAFT. THE KNOB CAN BE TOGGLED WITH A LIGHT APPLICATION OF ROTATIONAL FORCE, THE KNOB DOES NOT COME COMPLETELY UNDONE. DISASSEMBLY OF THE DEVICE IS STILL NOT POSSIBLE. ALTHOUGH NO DEFINITIVE ROOT-CAUSE CAN BE DETERMINED, IT IS POSSIBLE THAT THE DEVICE EXPERIENCED UNINTENDED FORCES THAT LEAD TO THE WELD FAILURE. THERE WAS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE CONTRIBUTED TO THE COMPLAINT. NO DESIGN ISSUES WERE OBSERVED DURING THE DOCUMENT/SPECIFICATION REVIEW. 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 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 AN UNKNOWN DATE THE KNOB OF THE SYNCAGE EVOLUTION SPINDLE HAS UNSCREWED FROM THE SHAFT. WHEN THE KNOB IS TURNED IT UNSCREWS FROM THE SHAFT AND THE SPINDLE CANNOT RELEASE THE TRIAL. AN ADDITIONAL SPINDLE WAS USED TO COMPLETE THE SURGERY WITHOUT PATIENT CONSEQUENCE. CONCOMITANT MEDICAL PRODUCTS: UNKNOWN TRIAL SPACER, (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1). UNKNOWN EVOLUTION IMPLANT HOLDER, (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) SYNCAGE EVOLUTION SPINDLE. THIS IS REPORT 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    993842 SYNCAGE EVOLUTION SPINDLE MISC. ORTHO SURGICAL INSTR.    LXH OBERDORF SYNTHES PRODUKTIONS GMBH H052900 07611819542303

    Patients

    Seq Age Sex Outcome Treatment
    1