BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 14287075 · Received May 5, 2022

    Report

    Report Number
    2939274-2022-01609
    Event Type
    Malfunction
    Date Received
    May 5, 2022
    Date of Event
    April 10, 2022
    Report Date
    May 4, 2022
    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
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL NARRATIVE: COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. INITIAL REPORTER IS A J&J EMPLOYEE. 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 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 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. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. H10: ADDITIONAL NARRATIVE: A1. H3, H4, H6: PART 03.043.033S-US, LOT 10282112: MANUFACTURING SITE: SELZACH. SUPPLIER: GEMÜ GMBH. RELEASE TO WAREHOUSE DATE: JANUARY 19, 2022. EXPIRATION DATE: OCTOBER 31, 2026. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED ARTICLE LOT AND NO NON-CONFORMANCES WERE IDENTIFIED. H3, H6: A PHOTO INVESTIGATION WAS COMPLETED: VISUAL ANALYSIS OF THE PHOTO REVEALED THAT THE DEVICE APPEARS TO BE DEFORMED ALONG THE SHAFT. BROKEN CONDITION CANNOT BE CONFIRMED SINCE EVIDENCE PROVIDED DOES NOT DISPLAY THE DEVICE COMPLETELY. AS THE DEVICE WAS NOT RETURNED, AN AS-RECEIVED CONDITION COULD NOT BE ASSESSED, AND A DIMENSIONAL INSPECTION AND DOCUMENT/SPECIFICATION REVIEW WERE NOT COMPLETED. AS PART OF DEPUY SYNTHES QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. THE OVERALL COMPLAINT WAS NOT CONFIRMED. THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE COMPLAINT CONDITION AND HENCE THE ROOT CAUSE CANNOT BE DETERMINED. 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. H11: CORRECTED DATA: G4: AWARENESS DATE ON INITIAL REPORTED AS APRIL 11, 2022; SHOULD HAVE BEEN APRIL 10, 2022.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON (B)(6) 2022 DURING AN UNKNOWN PROCEDURE THE PROTECTION SLEEVE OVER COLLAPSED AFTER INSERTION AND CAUSED NUMEROUS PROBLEMS INCLUDING REMOVING THE TROCAR AND SEQUENTIALLY REAMING FOR THE NAIL. A REAMER HEAD EVENTUALLY BECAME LODGED IN THE SLEEVE AND HAD TO REPLACE IT. PROCEDURE WAS COMPLETED WITH A SURGICAL DELAY OF 15-20 MINUTES. THIS REPORT IS FOR ONE PROTEC SLV/ FLEX/ LG FOR NL 8-11 / -S. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1462896 PROTEC SLV/ FLEX/ LG FOR NL 8-11 / -S ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH WRIGHTS LANE SYNTHES USA PRODUCTS LLC 03.043.033S 10282112 10886982298850

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Male UNK - INSERTION INSTRUMENTS: TROCAR: TRAUMA| UNK - NAILS| UNK - REAMERS