BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEX ARM

    MDR report key: 8336539 · Received February 13, 2019

    Report

    Report Number
    2939274-2019-56439
    Event Type
    Malfunction
    Date Received
    February 13, 2019
    Date of Event
    January 23, 2019
    Report Date
    January 23, 2019
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    LXH
    UDI-DI
    10705034714486
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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. H3, H4, H6: VISUAL INSPECTION THE FLEX ARM (PART 03.612.010, LOT P160243) WAS RETURNED TO US CUSTOMER QUALITY. UPON VISUAL INSPECTION, THE FLEX ARM DID WAS NOTED TO WIGGLE AS IT IS NO LONGER STIFF. THE REMAINDER OF THE DEVICE REVEALED NO DAMAGE OR DEFECT TO ANY OF THE ARM¿S COMPONENTS. MINOR WEAR WAS NOTED TO INTERIOR SURFACE OF THE BAND CLAMP, WHICH DID NOT CAUSE ANY FUNCTIONAL ISSUES. THE COMPLAINT CONDITION IS CONFIRMED AS THE DEVICE COULD NO LONGER RETAIN ITS RIGID CONSTRUCT AS INTENDED TO BE. NO DEFINITIVE ROOT CAUSE WAS ABLE TO BE DETERMINED HOWEVER THE FAILURE MODE IS CONSISTENT WITH WEAR/TEAR FOR MULTIUSE INSTRUMENT. FUNCTIONAL TESTING THE COMPLAINT COULD BE REPLICATED WITH THE RETURNED DEVICE. THE FUNCTIONAL TESTING WAS DONE BY TIGHTENING THE TENSIONING KNOB TO CREATE SUFFICIENT RIGIDITY OF THE FLEX ARM. THE BAND CLAMP KNOB WAS ALSO TIGHTENED COMPLETELY AS WELL. HOWEVER, THE ARM WAS NOT SUFFICIENTLY RIGID AFTER TIGHTENING. THE COMPLAINT CONDITION IS CONFIRMED. DOCUMENT REVIEW REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT, AND ANY SUBCOMPONENTS, WHICH WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. DIMENSIONAL INSPECTION : NO DIMENSIONAL ANALYSIS COULD NOT BE PERFORMED DUE TO POST MANUFACTURING DAMAGES. CONCLUSION: THE COMPLAINT CONDITION IS CONFIRMED. WHILE A DEFINITIVE ROOT CAUSE COULD BE DETERMINED, IT IS VERY LIKELY THAT THE AGE OF THE DEVICE (9+ YEARS) IS A CONTRIBUTING FACTOR FOR THIS FAILURE MODE. DURING THE INVESTIGATION, NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. 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 PART NUMBER: 03.612.010, SYNTHES LOT NUMBER: P160243, SUPPLIER LOT NUMBER: N/A, RELEASE TO WAREHOUSE DATE: 08SEP2009, EXPIRATION DATE: N/A, MANUFACTURED BY SYNTHES MONUMENT. NO NCRS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT, AND ANY SUBCOMPONENTS, WHICH 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 · 0

    DEPUY SYNTHESE IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHESE HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHESE OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHESE, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. 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. OUR TRACKING NUMBER :(B)(4). WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. PRODUCT WAS NOT RETURNED. 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 THAT A PATIENT UNDERWENT SPINAL FUSION ON (B)(6) 2019. THE SURGEON WAS DOING A MINIMALLY INVASIVE SURGERY (MIS) DECOMPRESSION, WHILE SETTING FOR THE CASE, IT WAS FOUND OUT THAT TWO (2) MIS FLEX ARMS WERE NOT AS STIFF AS WHAT IT WAS USED TO. THE CASE WAS COMPLETED WITHOUT USING OTHER MIS FLEX ARMS. THERE WAS NO SURGICAL DELAY. PROCEDURE OUTCOME IS UNKNOWN. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR ONE (1) FLEX ARM. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    130277 FLEX ARM MISC ORTHO SURGICAL INSTR LXH WRIGHTS LANE SYNTHES USA PRODUCTS LLC 03.612.010 10705034714486

    Patients

    Seq Age Sex Outcome Treatment
    1