BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLADE/SCREW GUIDE SLEEVE

    MDR report key: 9252662 · Received October 29, 2019

    Report

    Report Number
    2939274-2019-61815
    Event Type
    Malfunction
    Date Received
    October 29, 2019
    Report Date
    October 25, 2019
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    FZX
    UDI-DI
    10886982070333
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). A REVIEW OF THE DEVICE HISTORY RECORD. DEVICE HISTORY LOT: PART: 03.037.017, LOT: 9359339, MANUFACTURING SITE: BETTLACH, RELEASE TO WAREHOUSE DATE: 04 FEBRUARY 2015. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCE'S WERE IDENTIFIED. INVESTIGATION SUMMARY COMPLAINT SUMMARY: IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING ROUTINE INSPECTION, THE BUTTRESS NUT DID NOT GLIDE SMOOTHLY OVER THE THREADS OF THE TROCAR. THE TROCAR WAS WORN FROM USE. THERE WAS NO PATIENT INVOLVEMENT. CONCOMITANT DEVICE REPORTED: UNKNOWN BUTTRESS NUT (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY # 1), BLADE/SCREW GUIDE SLEEVE (PART # 03.037.017, LOT # UNKNOWN, QUANTITY # 4). THIS COMPLAINT INVOLVES ONE (1) DEVICE. UPON RECEIPT AT US CUSTOMER QUALITY (CQ), IT WAS OBSERVED THAT ONE (03.037.017; LOT 9359339) BLADE/SCREW GUIDE SLEEVE'S THREADS WERE NICKED AND THE DISTAL TOOTH WAS DEFORMED. THE RED POLYURETHANE ALIGNMENT MARKERS WERE MISSING. CQ INVESTIGATION FLOW: DAMAGE. VISUAL INSPECTION: THE GUIDE SLEEVE WAS RECEIVED WITH A SMALL NICK IN THE THREADS. THE DISTAL TOOTH WAS DEFORMED. THE RED POLYURETHANE ALIGNMENT MARKERS WERE PEELED OFF AND MISSING. THE MISSING POLYURETHANE MARKERS WERE INVESTIGATED UNDER CAPA (B)(4) AND DO NOT REQUIRE ANY ADDITIONAL INVESTIGATION FOR THIS DEFECT. NO OTHER ISSUES WERE OBSERVED WITH THE RETURNED DEVICE. DIMENSIONAL INSPECTION: DOCUMENT/SPECIFICATION REVIEW: THE FOLLOWING MANUFACTURED AND CURRENT DRAWING REVISIONS WERE REVIEWED; PROTECTION/GUIDE SLEEVE SE_405959 REV.'S I AND L DCO 094931 (REV. J) ADDED A STEP TO THE MANUFACTURING PROCESS TO COVER THE THREADS. SINCE THIS DEVICE'S THREADS MEASURED IN MULTIPLE LOCATIONS WITHIN SPECIFICATION, IT WAS DETERMINED DURING INVESTIGATION THAT DESIGN CHANGE WAS NOT RELEVANT TO THE COMPLAINT CONDITION. CONCLUSION: THE COMPLAINT CONDITION WAS CONFIRMED. DURING INVESTIGATION NO PRODUCT DESIGN OR MANUFACTURING ISSUES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. A ROOT CAUSE FOR THE THREAD AND DISTAL TOOTH DEFORMATION COULD NOT BE DETERMINED, HOWEVER, IT IS LIKELY THAT ROUGH HANDLING AND USE CONTRIBUTED TO THE DAMAGE. THE MISSING POLYURETHANE MARKERS WERE INVESTIGATED UNDER CAPA (B)(4) AND DO NOT REQUIRE ANY ADDITIONAL INVESTIGATION FOR THIS DEFECT. 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 THAT ON AN UNKNOWN DATE, DURING ROUTINE INSPECTION, THE BUTTRESS NUT DID NOT GLIDE SMOOTHLY OVER THE THREADS OF THE TROCAR. THE TROCAR WAS WORN FROM USE. THERE WAS NO PATIENT INVOLVEMENT. CONCOMITANT DEVICE REPORTED: UNKNOWN BUTTRESS NUT (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY # 1), BLADE/SCREW GUIDE SLEEVE (PART # 03.037.017, LOT # UNKNOWN, QUANTITY # 4). THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1046034 BLADE/SCREW GUIDE SLEEVE GUIDE FZX WRIGHTS LANE SYNTHES USA PRODUCTS LLC 03.037.017 9359339 10886982070333

    Patients

    Seq Age Sex Outcome Treatment
    1