BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUMERAL IMPLANT DRIVER

    MDR report key: 6092046 · Received November 10, 2016

    Report

    Report Number
    1818910-2016-31203
    Event Type
    Malfunction
    Date Received
    November 10, 2016
    Date of Event
    October 31, 2016
    Report Date
    December 13, 2016
    Manufacturer
    DEPUY FRANCE SAS 3003895575
    Product Code
    HWR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DESCRIPTION STATES THAT THE HUMERAL STEM DRIVER REF NO 2307-83-000 WAS STUCK ON TRIAL STEM. WHEN REPRESENTATIVE TRIED TO DETACH IT, THE INSTRUMENTS LOCKING DEVICE BROKE. THE DEVICE ASSOCIATED TO THE COMPLAINT WAS RETURNED FOR ANALYSIS. THE VISUAL ANALYSIS SHOWS THE BREAK OF THE 4 SCREWS OF THE LOWER PLATE. THE DHR ANALYSIS PERFORMED DID NOT REVEAL ANY ANOMALIES THAT COULD BE RELATED TO THE ISSUE REPORTED ON THE COMPLAINT. PREVIOUS COMPLAINTS WERE RECEIVED FOR A SIMILAR INCIDENT ((B)(4)). THE ANALYSIS PERFORMED BY R&D CONCLUDED THAT: THE SCREWS ARE AN M4 THREADED COUNTERSUNK HEXAGON SOCKET SCREW. THE DRAWING FOR THE SCREW (DWG-8E070273_REV_B) SPECIFIES A HEXAGON DEPTH OF 2MM±0.2MM. (I.E. MAXIMUM DEPTH CAN BE 2.2MM); THE NOTES IN THE DRAWING REFERS TO DIN 7991 (A STANDARD FOR SOCKET COUNTERSUNK SCREWS) DIN 7991 SPECIFIES A HEX DEPTH OF 1.55-1.8MM FOR AN M4 SIZE. THIS IS A CONTRADICTION, ALLOWING MUCH LESS MATERIAL IN THE CROSS SECTION OF THE SCREW WHERE THE FRACTURE OCCURS. THE 0.4MM DEVIATION IN DEPTH BETWEEN THE SPECIFICATIONS DECREASE THE WALL THICKNESS BY 25%. FURTHERMORE, THE RISK MANAGEMENT ((B)(4)) WAS REVIEWED AND IT DID NOT INCLUDE THE FAILURE MODE IDENTIFIED IN THIS COMPLAINT. THE COMPLAINTS WERE REVIEWED BY A MEDICAL SAFETY OFFICER AND IT WAS CONCLUDED THAT THERE WAS NO PATIENT HARM ASSOCIATED WITH THE FAILURE MODE AND THE OCCURRENCE WAS REMOTE. GIVEN THE LOW LEVEL OF SEVERITY AND OCCURRENCE OF THE FAILURE MODE NO IMMEDIATE ACTIONS WERE REQUIRED AND ALL PRODUCT COULD BE DISPOSITIONED ¿USE AS IS¿. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED. (B)(4). 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

    THIS COMPLAINT REMAINS UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THE INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    HUMERAL STEM DRIVER WAS STUCK ON TRIAL STEM. WHEN REPRESENTATIVE TRIED TO DETACH IT, THE INSTRUMENTS LOCKING DEVICE BROKE.

    Description of Event or Problem · 1

    DATE OF MANUFACTURE WAS CORRECTED AND PRODUCT RECEIVED DATE ADDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    745772 HUMERAL IMPLANT DRIVER SHOULDER INSTRUMENT/TRIAL HWR DEPUY FRANCE SAS 3003895575 5026573

    Patients

    Seq Age Sex Outcome Treatment
    1