BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOCKING SCREWDRIVER BODY

    MDR report key: 3932621 · Received July 14, 2014

    Report

    Report Number
    1818910-2014-23279
    Event Type
    Malfunction
    Date Received
    July 14, 2014
    Date of Event
    June 24, 2014
    Report Date
    June 24, 2014
    Manufacturer
    DEPUY FRANCE SAS 3003895575
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

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

    Additional Manufacturer Narrative · 1

    A DEPUY (B)(4) SUPPLIER EXAMINED THE RETURNED INSTRUMENT AND CONFIRMED TWO OF THE FOUR TEETH BROKE OFF. REVIEW OF THE DEVICE HISTORY RECORDS FOUND THE PRODUCT CONFORMED TO THE REQUIRED SPECIFICATIONS AND FOUND NO MANUFACTURING DEVIATIONS OR ANOMALIES. PREVIOUS INVESTIGATIONS FOUND A TREND HAS BEEN IDENTIFIED FOR THIS FAILURE MODE. A HEALTH HAZARD EVALUATION MEETING WAS CONDUCTED ON JULY 2, 2013 AND IDENTIFIED A POTENTIAL HARM; DOCUMENTED IN (B)(4), COMPLETED ON SEPTEMBER 25, 2013. MDD (B)(4) WAS INITIATED ON JULY 19, 2013 TO DETERMINE ROOT CAUSE AND CORRECTIVE ACTIONS NEEDED. THE ISSUE AND HARM WAS FORWARDED TO THE QUALITY REVIEW BOARD WHO DETERMINED NO BOND IS REQUIRED. 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.

    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.

    Description of Event or Problem · 1

    PROCEDURE: REVERSE TOTAL SHOULDER REPLACEMENT. THE CROWNS ON THE TIP OF THE SCREWDRIVER BROKE OFF. NOTHING FELL INTO PATIENT. CONTINUED TO USE THE SAME INSTRUMENT TO FINISH THE TASK. NO DELAY TO PROCEDURE. NO ADVERSE EVENT TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    409702 LOCKING SCREWDRIVER BODY SHOULDER INSTRUMENT/TRIAL LXH DEPUY FRANCE SAS 3003895575 5024145

    Patients

    Seq Age Sex Outcome Treatment
    1