BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HP QUICK DRILL PINS 6PK

    MDR report key: 7966558 · Received October 15, 2018

    Report

    Report Number
    1818910-2018-72551
    Event Type
    Malfunction
    Date Received
    October 15, 2018
    Date of Event
    October 8, 2018
    Report Date
    October 8, 2018
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    LHX
    UDI-DI
    10603295227885
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT #: (B)(4). INVESTIGATION SUMMARY: EXAMINATION OF THE RETURNED DEVICE CONFIRMS THE REPORTED EVENT. 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. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (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

    PRODUCT COMPLAINT #: (B)(4). INVESTIGATION SUMMARY: EXAMINATION OF THE RETURNED DEVICE CONFIRMS THE REPORTED EVENT. 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. 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 THE TIBIA CUTTING BLOCK WAS FOUND WITH A HEADED DRILL PIN STUCK AND BROKEN INSIDE A PIN HOLE BEFORE THE CASE STARTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    806237 HP QUICK DRILL PINS 6PK DRILLS (BITS, SLEEVES, GUIDES) : DRILLS LHX DEPUY ORTHOPAEDICS INC US UNKNOWN 10603295227885

    Patients

    Seq Age Sex Outcome Treatment
    1