BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLAVICLE PIN ASSEMBLY 2.5MM

    MDR report key: 1170243 · Received September 10, 2008

    Report

    Report Number
    1818910-2008-03633
    Event Type
    Malfunction
    Date Received
    September 10, 2008
    Date of Event
    August 11, 2008
    Report Date
    August 11, 2008
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    JDW
    PMA / PMN Number
    K991649
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION WAS NOT POSSIBLE, AS THE PRODUCT WAS NOT RETURNED. THE SURGICAL TECHNIQUE STATE TAPPING REDUCES THE TORQUE REQUIRED TO INSERT THE PIN AND REDUCES THE POSSIBILITY OF PIN FAILURE. SHOULD THE TAP BE A TIGHT FIT, CONSIDER RE-DRILLING WITH THE NEXT LARGER DRILL SIZE. AGAIN, HAND TAPPING IS HIGHLY RECOMMENDED, ESPECIALLY FOR MORE SLIGHT PATIENT ANATOMIES AND SMALLER DIAMETER-SIZED CLAVICLE PINS. A SEARCH OF THE COMPLAINT DATABASE FOUND NO PRIOR REPORTS FOR THIS PART AND LOT NUMBER COMBINATION. THE INVESTIGATION COULD NOT VERIFY OR IDENTITY ANY PRODUCT CONTRIBUTION TO 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 ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    Description of Event or Problem · 1

    CLAVICLE PIN ASSEMBLY BROKE DURING INSERTION ON HAND-POWERED CHUCK AND T-HANDLE. SURGEON ELECTED TO LEAVE BROKEN DEVICE IN PATIENT, AS HE WAS ABLE TO ACHIEVE COMPRESSION OF FRACTURE (LEFT SIDE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLAVICLE PIN ASSEMBLY 2.5MM 87JDW JDW DEPUY ORTHOPAEDICS, INC. NA B58JX1000

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR