BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROTEC SLV/ FLEX/ LG FOR NL 8-11 / -S

    MDR report key: 12721327 · Received October 29, 2021

    Report

    Report Number
    2939274-2021-06381
    Event Type
    Malfunction
    Date Received
    October 29, 2021
    Date of Event
    October 5, 2021
    Report Date
    October 5, 2021
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    LXH
    UDI-DI
    10886982298850
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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 HISTORY LOT, PART #: 03.043.033S, SYNTHES LOT #: 10239557, SUPPLIER LOT #: N/A, RELEASE TO WAREHOUSE DATE: 26 JUL 2021, MANUFACTURED BY: WERK SELZACH, SUPPLIER: GEMÜ GMBH, NO NCR'S GENERATED DURING PRODUCTION. DEVICE HISTORY REVIEW: REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT, AND ANY SUB-COMPONENTS, 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2021 DURING A SUPRAPATELLAR TIBIAL NAIL PROCEDURE, THE SURGEON EXPERIENCED DIFFICULTY ADVANCING THE REAMER INSIDE THE PROTEC SLEEVE AND UNKNOWN SLEEVE. THE FIRST SLEEVE WAS DAMAGED AND A SECOND WAS OPENED WHICH WAS USED TO SUCCESSFULLY COMPLETE THE SURGERY. THERE WAS A SURGICAL DELAY OF FIVE (5) MINUTES. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR ONE (1) PROTEC SLV/ FLEX/ LG FOR NL 8-11 / -S. THIS IS REPORT 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1621771 PROTEC SLV/ FLEX/ LG FOR NL 8-11 / -S ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH WRIGHTS LANE SYNTHES USA PRODUCTS LLC 03.043.033S 10239557 10886982298850

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR UNK - DRILL| UNK - GUIDES/SLEEVES/AIMING: SLEEVE| UNK - REAMERS