BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3.5MM CORT LOCK SCRW 26MM

    MDR report key: 1080107 · Received July 18, 2008

    Report

    Report Number
    1818910-2008-02675
    Event Type
    Injury
    Date Received
    July 18, 2008
    Date of Event
    June 20, 2008
    Report Date
    June 20, 2008
    Manufacturer
    DEPUY ACE S.A. 'R.L.
    Product Code
    HRS
    PMA / PMN Number
    K072832
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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 LOT NUMBER REQUIRED TO REVIEW THE DEVICE HISTORY RECORDS WAS NOT PROVIDED. PROVIDED INFO STATES THE SCREW WOULD NOT LOCK BECAUSE IT WOULD NOT ENGAGE THE FAR CORTEX. ALTHOUGH THE COMPLAINT IS NON-VERIFIABLE, THE PT'S AGE, ACTIVITY LEVEL, AND BONE QUALITY MAY BE A CONTRIBUTING FACTOR. 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

    THE SCREW HEAD BROKE DURING INSERTION CAUSING A 20 MINUTE DELAY IN SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 3.5MM CORT LOCK SCRW 26MM 87HRS HRS DEPUY ACE S.A. 'R.L. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR