BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOLDING SLEEVE

    MDR report key: 10182588 · Received June 22, 2020

    Report

    Report Number
    2939274-2020-02927
    Event Type
    Malfunction
    Date Received
    June 22, 2020
    Report Date
    June 8, 2020
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HXX
    UDI-DI
    10887587037196
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    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. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. H10 ADDITIONAL NARRATIVE: D10. G1. H3, H4, H6: LOT 3192913 IS ASSOCIATED TO ARTICLE 313.940 WHICH BELONGS TO ARTICLE 313.970. HENCE, DHR REVIEW WILL BE PERFORMED WITH 313.940 AND LOT 3192913: PART: 313.940. LOT: 3192913. MANUFACTURING SITE: HÄGENDORF. RELEASE TO WAREHOUSE DATE: 19.JUN.2009. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. VISUAL INSPECTION: THE HOLDING SLEEVE (PRODUCT CODE: 313.97 & LOT NO: 3192913) WAS RECEIVED AT US CUSTOMER QUALITY (CQ) WITH ALL COMPONENTS DISASSEMBLED. UPON VISUAL INSPECTION AND ASSEMBLY OF ALL COMPONENTS, NO BREAKAGE OR DEFECT WAS OBSERVED ON THE DEVICE. NO OTHER ISSUES WERE IDENTIFIED ON THE DEVICE. DEVICE FAILURE/DEFECT IDENTIFIED? NO FAILURE DETECTED. INVESTIGATION CONCLUSION: THE COMPLAINT WAS NOT CONFIRMED FOR THE RECEIVED HOLDING SLEEVE AS NO DEFECT OR FAILURE IDENTIFIED ON THE DEVICE. 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.

    Additional Manufacturer Narrative · 1

    COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING INCOMING INSPECTION OF A LOANER SET, IT WAS OBSERVED THAT THE 2.4MM CRUCIFORM SCREWDRIVER WITH HOLDING SLEEVE WAS DAMAGED WITH A BROKEN HANDLE. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES 1 DEVICE. THIS REPORT IS FOR (1) HOLDING SLEEVE. THIS IS REPORT 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    641795 HOLDING SLEEVE SCREWDRIVERS HXX WRIGHTS LANE SYNTHES USA PRODUCTS LLC 313.97 3192913 10887587037196

    Patients

    Seq Age Sex Outcome Treatment
    1