BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTER-LOCK SCREWDRIVER T25/3.5MM HEX/224MM

    MDR report key: 9257113 · Received October 30, 2019

    Report

    Report Number
    2939274-2019-61836
    Event Type
    Malfunction
    Date Received
    October 30, 2019
    Date of Event
    October 11, 2019
    Report Date
    October 14, 2019
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HXX
    UDI-DI
    10886982068941
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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. PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND 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 NUMBER: 03.010.473. SYNTHES LOT NUMBER: 9920536. MANUFACTURING SITE: HÄGENDORF. RELEASE TO WAREHOUSE DATE: JULY 08, 2016. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. 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

    THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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 (B)(6) 2019, THE PATIENT UNDERWENT A FEMORAL NAILING PROCEDURE. DURING THE PROCEDURE, THE TIP OF AN INTER-LOCK SCREWDRIVER BECAME TWISTED BUT FUNCTIONED PROPERLY. IT DID NOT AFFECT THE CASE AND THE PATIENT. HOWEVER, AFTER THE CASE WHEN THE HOSPITAL STAFF WAS CLEANING AND PUTTING THE TRAY BACK TOGETHER IT WAS NOTICED THAT THE TIP OF THE INTER-LOCK SCREWDRIVER LOOKS BENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY. THERE WAS NO IMPACT ON THE PATIENT. THIS REPORT IS FOR ONE (1) INTER-LOCK SCREWDRIVER T25/3.5MM HEX/224MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1049553 INTER-LOCK SCREWDRIVER T25/3.5MM HEX/224MM SCREWDRIVERS HXX WRIGHTS LANE SYNTHES USA PRODUCTS LLC 03.010.473 9920536 10886982068941

    Patients

    Seq Age Sex Outcome Treatment
    1