BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATTUNE PIN PULLER

    MDR report key: 7300819 · Received February 27, 2018

    Report

    Report Number
    1818910-2018-54212
    Event Type
    Malfunction
    Date Received
    February 27, 2018
    Report Date
    February 8, 2018
    Manufacturer
    DEPUY IRELAND - 9616671
    Product Code
    HWB
    UDI-DI
    10603295130574
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY: EVALUATION AND FUNCTIONAL TESTING OF THE RETURNED DEVICE WAS UNABLE TO CONFIRM 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. 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

    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).

    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
    142532 ATTUNE PIN PULLER ATTUNE INSTRUMENTS : EXTRACTION INSTRUMENTS HWB DEPUY IRELAND - 9616671 PG246436 10603295130574

    Patients

    Seq Age Sex Outcome Treatment
    1