BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNFRAME EXTENSION-ADJUSTABLE

    MDR report key: 9912433 · Received April 1, 2020

    Report

    Report Number
    2939274-2020-01664
    Event Type
    Malfunction
    Date Received
    April 1, 2020
    Report Date
    March 6, 2020
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    LXH
    UDI-DI
    10705034771038
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PART: 387.334, LOT: L881359, MANUFACTURING SITE: (B)(6), RELEASE TO WAREHOUSE DATE: 14.MAY 2018. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. VISUAL INSPECTION: THE SYNFRAME EXTENSION-ADJUSTABLE (PART # 387.334, LOT # L881359, MFG # 14-MAY-2018) WAS RECEIVED AT US CUSTOMER QUALITY (CQ) WITH THE EXTENSION ADJUSTED TO AN ANGLE AND TIGHTENED. FUNCTIONAL TEST: THE SCREW THAT HOLDS THE STRUCTURE IN PLACE WAS VERY TIGHT AND A LOT OF FORCE WAS REQUIRED TO UNTIGHTEN IT. THE SCREW COULD ONLY BE UNTIGHTENED TO A CERTAIN POINT AND THEN JAMMED AGAIN. EVEN THOUGH THE DEVICE IS NOT DEFORMED OR BENT, IT IS IN THE BENT STATE AND UNABLE TO BE CHANGED TO THE ORIGINAL POSITION, THEREFORE THE COMPLAINT IS CONFIRMED. DIMENSIONAL INSPECTION: DIMENSIONAL ANALYSIS WAS NOT PERFORMED AS RELEVANT FEATURES ARE INACCESSIBLE. DOCUMENT/SPECIFICATION REVIEW: THE FOLLOWING DRAWING(S) WAS REVIEWED; - VERLAENG M/RASTVERRIEG. CONCLUSION: THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE CONTRIBUTED TO THE COMPLAINT. WHILE NO DEFINITIVE ROOT CAUSE COULD BE DETERMINED IT IS POSSIBLE THAT THE DEVICE ENCOUNTERED UNINTENDED FORCES. NO NEW MALFUNCTIONS WERE OBSERVED DURING THE COURSE OF THIS INVESTIGATION. 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

    IT WAS REPORTED ON FEBRUARY 17, 2020, DURING EVALUATION OF THE DEVICES TWO (2) SYNFRAME EXTENSIONS WERE FOUND UNABLE TO BE STRAIGHTENED. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) SYNFRAME EXTENSION-ADJUSTABLE. THIS IS REPORT 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    375049 SYNFRAME EXTENSION-ADJUSTABLE MISC ORTHO SURGICAL INSTR LXH WRIGHTS LANE SYNTHES USA PRODUCTS LLC 387.334 L881359 10705034771038

    Patients

    Seq Age Sex Outcome Treatment
    1