BEUDAMED
    FDA Adverse Event Injury Summary report: N

    4.0 CANN.CANC.BONE SCREW

    MDR report key: 1240007 · Received November 19, 2008

    Report

    Report Number
    1818910-2008-05167
    Event Type
    Injury
    Date Received
    November 19, 2008
    Report Date
    October 26, 2008
    Manufacturer
    DEPUY ACE S.A. 'R.L.
    Product Code
    HWC
    PMA / PMN Number
    K903810
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION WAS NOT POSSIBLE, AS THE PRODUCT WAS NOT RETUNED. A SEARCH OF THE COMPLAINT DATABASE FOUND NO PRIOR REPORTS FOR THIS PART AND LOT NUMBER COMBINATION. PROVIDED INFORMATION STATES THE PATIENT'S BONE WAS TOO HARD. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY PRODUCT CONTRIBUTION TO THE REPORTED EVENT. BASED ON THE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD THE PRODUCT AND/OR ANY ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    Description of Event or Problem · 1

    DURING THE SURGERY, WHEN THE DOCTOR WAS INSERTING THE SCREW AROUND ACETABULUM BY THE HANDS, THE SCREW HEAD WAS BROKEN. THE BROKEN SCREW SHAFT REMAINED IN THE PATIENT'S BODY AND SURGERY WAS COMPLETED. ONLY SCREW HEAD WAS REMOVED FROM THE PATIENT'S BODY. ACCORDING TO THE DOCTOR, THE PATIENT'S BONE WAS TOO HARD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 4.0 CANN.CANC.BONE SCREW 87HWC HWC DEPUY ACE S.A. 'R.L. NA DGBBP8

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention