BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOCKING SCREWDRIVER BODY

    MDR report key: 7236742 · Received February 2, 2018

    Report

    Report Number
    1818910-2018-52601
    Event Type
    Malfunction
    Date Received
    February 2, 2018
    Date of Event
    December 19, 2017
    Report Date
    January 16, 2018
    Manufacturer
    DEPUY FRANCE SAS - 3003895575
    Product Code
    HXX
    UDI-DI
    10603295116561
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # PC-(B)(4). INVESTIGATION SUMMARY THE COMPLAINT DESCRIPTION STATES THAT THE JNJ REP NOTICED THE TIP HAD BROKEN OFF. THE DEVICE ASSOCIATED TO THE COMPLAINT WAS RETURNED FOR ANALYSIS. THE REPORTED ISSUE IS CONFIRMED, ONE OF THE TAB OF THE SCREWDRIVER IS BROKEN. PREVIOUS INVESTIGATIONS IDENTIFIED A TREND FOR THE TEETH BREAKING. THE ISSUE WAS REVIEWED WITH THE QUALITY REVIEW BOARD IN (B)(4) 2013 (DVA-(B)(4)) AND (B)(4), (B)(4) 2017 ((B)(4)). FOR BOTH REVIEWS, THE QRB DETERMINED THAT NO FIELD ACTION WAS NECESSARY DUE TO THE LOW OCCURRENCE. MDD CAPA-001649 WAS INITIATED FOR THIS ISSUE. THE ROOT CAUSE WAS DETERMINED TO BE INADEQUATE DESIGN FOR UNINTENDED OFF-AXIS USE. A REDESIGN OF THE DELTA EXTEND SCREWDRIVER GUIDE IS ONGOING TO ENSURE THAT THE SCREWS ARE CAPTURED PROPERLY AND TORQUED "ON-AXIS," THUS PREVENTING OVERLOADING OF THE TEETH IN THE SCREWDRIVER, WHICH COULD RESULT IN THE FRACTURING OF THE TEETH AS SEEN IN THE INITIAL COMPLAINTS. BASED ON THE INFORMATION RECEIVED AND THE INVESTIGATION PERFORMED, THE ROOT CAUSE OF THE INCIDENT IS RELATED TO PRODUCT DESIGN. THE ISSUE WILL BE MONITORED THROUGH POST MARKET SURVEILLANCE REVIEWS. 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

    (B)(4). 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

    DURING A SALES TRAINING PROCEDURE, THE JNJ REP NOTICED THE TIP HAD BROKEN OFF. "THIS CASE HAS BEEN REPORTED BY THE LOAN KIT TECHNICIAN DURING LOAN KIT INSPECTION. IT HAS BEEN FORWARDED TO DEPUY ENGINEERING FOR ASSESSMENT. NO FURTHER INFORMATION CAN BE OBTAINED AS THE CASE WAS NOT REPORTED BY THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    81590 LOCKING SCREWDRIVER BODY EXTREMITY INSTRUMENTS : SCREWDRIVERS HXX DEPUY FRANCE SAS - 3003895575 5282305 10603295116561

    Patients

    Seq Age Sex Outcome Treatment
    1