BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEAK FX KEY ASSY NS

    MDR report key: 1230749 · Received October 27, 2008

    Report

    Report Number
    1818910-2008-04948
    Event Type
    Malfunction
    Date Received
    October 27, 2008
    Date of Event
    October 13, 2008
    Report Date
    October 13, 2008
    Manufacturer
    DEPUY ACE S.A. 'R.L
    Product Code
    KTT
    PMA / PMN Number
    K063509
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION WAS NOT POSSIBLE, AS THE PRODUCT WAS NOT RETURNED. THE INVESTIGATION WAS LIMITED TO THE INFO PROVIDED, AS THE LOT NUMBER REQUIRED TO REVIEW THE DEVICE HISTORY RECORDS WAS NOT PROVIDED. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS ABOUT THE REPORTED EVENT. BASED ON THE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. DEPUY WARSAW CONSIDERS THE INVESTIGATION CLOSED. SHOULD THE PRODUCT AND/OR ANY ADD'L INFO BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    Description of Event or Problem · 1

    KEY WOULD NOT ENGAGE/LOCK LAG SCREW IN PLACE. EXTENDED THE SURGICAL PROCEDURE BY MORE THAN 15 MINUTES. SURGEON WENT WITH A DIFFERENT SCREW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PEAK FX KEY ASSY NS 87KTT KTT DEPUY ACE S.A. 'R.L NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention