BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PW QDRILL PIN PACK (6 PINS)

    MDR report key: 3894515 · Received June 25, 2014

    Report

    Report Number
    1818910-2014-21947
    Event Type
    Malfunction
    Date Received
    June 25, 2014
    Date of Event
    June 6, 2014
    Report Date
    June 6, 2014
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. 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

    THE INSTRUMENT ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. REVIEW OF A SUPPLIED PHOTOGRAPH CONFIRMED THE REPORTED BREAKAGE.. REVIEW OF THE DEVICE HISTORY RECORDS AND/OR A COMPLAINT DATABASE SEARCH WAS NOT POSSIBLE AS THE PRODUCT LOT CODE REQUIRED WAS NOT PROVIDED. A SEARCH OF THE COMPLAINT DATABASE FOUND PREVIOUS REPORTS OF 217842010 PIN BREAKAGE. PREVIOUS INVESTIGATIONS HAVE FOUND AN OVERLOAD CONDITION IS THE MOST LIKELY ROOT CAUSE. HOWEVER, A TREND OF THIS ISSUE WAS IDENTIFIED AND CAPA (B)(4) WAS INITIATED TO INVESTIGATE THIS TYPE OF FRACTURE. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS ABOUT THE CURRENT REPORTED EVENT WITH THE PROVIDED INFORMATION. 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.

    Description of Event or Problem · 1

    THE LONG LCS PINS ON THE LOAN SET WERE SLIGHTLY BENT. ONE OF THE DRILL PINS (LONG LCS PINS ON DR VERTZYAS PREFERENCES) BROKE IN HALF WHILST PINNING THE DISTAL FEMORAL BLOCK ON. THERE WAS NO DELAY IN THE PROCEDURE. SURGEON CONTINUED ON USING SPARE PINS THAT ARE ON CONSIGNMENT. THE PIN WAS ACCIDENTALLY THROWN OUT BY THE SCRUB NURSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    371236 PW QDRILL PIN PACK (6 PINS) KNEE INSTRUMENT/TRIAL LXH DEPUY ORTHOPAEDICS, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1