BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRILL TWIST SCP 2.9X120MM

    MDR report key: 772550 · Received August 15, 2006

    Report

    Report Number
    1818910-2006-02566
    Event Type
    Malfunction
    Date Received
    August 15, 2006
    Date of Event
    August 10, 2006
    Report Date
    August 10, 2006
    Manufacturer
    DEPUY ACE S.R. 'R.L.
    Product Code
    HTW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION WAS NOT POSSIBLE, AS THE PRODUCT WAS LEFT INSIDE THE PT. THE INVESTIGATION WAS LIMITED TO THE INFO PROVIDED, AS THE LOT NUMBER TO REVIEW THE DEVICE HISTORY RECORDS WAS NOT PROVIDED. A TWO-YEAR SEARCH OF THE COMPLAINT DATABASE FOUND NO PRIOR REPORTS FOR THIS PRODUCT NUMBER. BASED ON THE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. DEPUY WARSAW CONSIDERS THE INVESTIGATION CLOSED. SHOULD ANY ADD'L INFO BE RECEIVED, THE INVESTIGATION WILL BE REOPENED.

    Description of Event or Problem · 1

    DURING SURGERY, THE DRILL BIT BROKE IN THE PT'S TIBIA DUE TO IMPACTION WITH A WIRE FROM AN EXTERNAL FIXATOR. THE DRILL BIT WAS LEFT IN THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DRILL TWIST SCP 2.9X120MM MANUAL INSTRUMENT HTW DEPUY ACE S.R. 'R.L. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention