BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PFC 3INHDLES STEINMN PIN PKG10

    MDR report key: 7300556 · Received February 27, 2018

    Report

    Report Number
    1818910-2018-54209
    Event Type
    Malfunction
    Date Received
    February 27, 2018
    Report Date
    February 8, 2018
    Manufacturer
    DEPUY ORTHOPAEDICS INC US 1818910
    Product Code
    LXH
    UDI-DI
    10603295218142
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    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.

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY: THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. THE INITIAL REPORT STATED THE DEVICE WOULD NOT BE RETURNED FOR EVALUATION. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY PRODUCT CONTRIBUTION TO THE REPORTED EVENT WITH THE INFORMATION PROVIDED AS THE REPORTED DEVICE WAS NOT RETURNED FOR EVALUATION. 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

    I¿VE RECEIVED A COMPLAINT FROM (B)(6) TODAY RE SOME PROBLEMS THEY HAVE HAD WITH KNEE PIN JACK CODE D254500060. THEY HAVE RETURNED X2 OF THESE PIN JACKS BOTH FROM LOT D254500060. THEY HAVE BEEN USING THEM WITH PFC SIGMA KNEES REUSABLE PINS (I KNOW THEY WERE DESIGNED FOR ATTUNE DISPOSABLE PINS) BUT WE WERE INFORMED SHOULD STILL BE COMPATIBLE WITH PFC PINS AS SAME DIAMETER AND SURGEON PARTICULARLY LIKES THE INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    144293 PFC 3INHDLES STEINMN PIN PKG10 BONE SCREWS AND PINS : FIXATION PINS LXH DEPUY ORTHOPAEDICS INC US 1818910 UNKNOWN 10603295218142

    Patients

    Seq Age Sex Outcome Treatment
    1