BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3RD BLADE HOLDER

    MDR report key: 8805391 · Received July 18, 2019

    Report

    Report Number
    2939274-2019-59270
    Event Type
    Malfunction
    Date Received
    July 18, 2019
    Report Date
    June 25, 2019
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    GAD
    UDI-DI
    10705034730653
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED, THE INVESTIGATION IS IN PROGRESS, NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING THIS REPORT. A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN REQUESTED. DEVICE HISTORY LOT- PART: 03.816.004, LOT: L881230. MANUFACTURING SITE: (B)(4). RELEASE TO WAREHOUSE DATE: 23. NOVEMBER 2018. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. INVESTIGATION SUMMARY BACKGROUND: VISUAL INSPECTION, FUNCTIONAL TESTING, AND DOCUMENT SPECIFICATION REVIEW OF THE RECEIVED DEVICE WAS PERFORMED AT CQ. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. DURING THE INVESTIGATION NO UNIDENTIFIED PRODUCT DESIGN/MANUFACTURING 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. THIS COMPLAINT INVOLVES TWO (2) DEVICES. INVESTIGATION FLOW: FUNCTIONAL/ DEVICE INTERACTION. VISUAL INSPECTION: 3RD BLADE HOLDER WAS RECEIVED AT CQ. UPON VISUAL INSPECTION AT CQ, IT IS OBSERVED THAT THE SURFACE OF THE DEVICE DOES NOT SHOW ANY DAMAGE THAT WOULD CONTRIBUTE TO THE COMPLAINT CONDITION. FUNCTIONAL TEST: FUNCTIONAL TEST WAS PERFORMED AT CQ. THE THIRD BLADE HOLDER WAS TRIED TO BE INSERTED INTO RETRACTOR BODY AND IT WAS SLIDING PROPERLY INTO RETRACTOR BODY (03.816.001). THUS, THE REPORTED DEVICE INTERACTION CONDITION CANNOT BE CONFIRMED. BUT, THE REPORTED DEVICE INTERACTION CONDITION CANNOT BE CONFIRMED. DIMENSIONAL INSPECTION: DIMENSIONAL INSPECTION IS NOT REQUIRED AS THE COMPLAINT CANNOT BE CONFIRMED DURING FUNCTIONAL TESTING. DOCUMENT/ SPECIFICATION REVIEW: NO DESIGN ISSUES OR DISCREPANCIES WERE FOUND DURING THIS INVESTIGATION. INVESTIGATION CONCLUSION: VISUAL INSPECTION, FUNCTIONAL TESTING, AND DOCUMENT SPECIFICATION REVIEW OF THE RECEIVED DEVICE WAS PERFORMED AT CQ. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. DURING THE INVESTIGATION NO UNIDENTIFIED PRODUCT DESIGN/MANUFACTURING 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 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 (B)(6) 2019, DURING AN INSPECTION OF THE LOANER SET, A RETRACTOR BODY AND A 3RD BLADE HOLDER WERE NOT FUNCTIONING CORRECTLY. THE 3RD BLADE HOLDER WAS DISCOVERED NOT ALLOWING THE BLADE TO BE INSERTED FLUSH. THE ISSUE WAS DISCOVERED DURING AN OVERVIEW BEFORE CHECKING THE SET IN  STERILE PROCESSING DEPARTMENT (SPD). THERE WAS NO PATIENT AND PROCEDURE INVOLVEMENT.  THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    599493 3RD BLADE HOLDER RETRACTOR GAD WRIGHTS LANE SYNTHES USA PRODUCTS LLC 03.816.004 L881230 10705034730653

    Patients

    Seq Age Sex Outcome Treatment
    1