BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APG+ STRAIGHT HANDLE OUTER

    MDR report key: 7872213 · Received September 13, 2018

    Report

    Report Number
    1818910-2018-69226
    Event Type
    Malfunction
    Date Received
    September 13, 2018
    Date of Event
    August 20, 2018
    Report Date
    August 20, 2018
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    LXH
    UDI-DI
    10603295102984
    PMA / PMN Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # ==> (B)(4). INVESTIGATION SUMMARY ==> NO DEVICE WAS RECEIVED. DEPUY SYNTHES CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION MAY BE RE-OPENED AS NECESSARY. DEVICE HISTORY LOT ==> NULL. DEVICE HISTORY BATCH ==> NULL. DEVICE HISTORY REVIEW ==> NULL. 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

    HANDLE (2230-00-025) WOULD NOT FIT INTO EITHER RASP GUIDE 2230-10-282 OR PERIPHERAL DRILL GUIDE (2230-00-081). THIS FORCED THE SURGEON TO USE KOCHERS TO SET THE GUIDES WHICH LACKED STABILITY WHILE PERFORMING SURGICAL STEPS ASSOCIATED WITH EACH PIECE. THIS CAUSED 10 MINUTES OF ADDITIONAL SURGICAL TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    714413 APG+ STRAIGHT HANDLE OUTER EXTREMITY INSTRUMENTS : SCREWDRIVERS LXH DEPUY ORTHOPAEDICS INC US PC3366436 10603295102984

    Patients

    Seq Age Sex Outcome Treatment
    1