BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2520274-2013-04837

    MDR report key: 3253791 · Received July 30, 2013

    Report

    Report Number
    2520274-2013-04837
    Event Type
    Injury
    Date Received
    July 30, 2013
    Date of Event
    June 20, 2013
    Report Date
    June 20, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Additional Manufacturer Narrative · 1

    A MANUFACTURING EVALUATION WAS CONDUCTED AND IT STATES THAT THE SCREWS SHOW SIGNS OF HEAVY USE WITH THE THREADS BEING MASHED, DISCOLORATION OVERALL, AND WORN HEX HEADS. ONE SCREW IS BROKEN AND THE TIP IS MISSING. THE SCREWS ARE FROM AN UNKNOWN LOT AND UNKNOWN PART NUMBER. THE MATERIAL OF THE SCREWS WAS DETERMINED TO BE TIALNB. BASED ON THE LACK OF INFORMATION, THE UNKNOWN ROOT CAUSE, AND THE EVALUATION PERFORMED BY SYNTHES, THIS COMPLAINT IS DEEMED INDETERMINATE FROM A MANUFACTURING POSITION.

    Additional Manufacturer Narrative · 1

    SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ONGOING; NO CONCLUSION COULD BE DRAWN.

    Description of Event or Problem · 1

    PATIENT HAD AN OPEN FRACTURE MID TO DISTAL SHAFT RIGHT TIBIA ON (B)(6) 2012. ON (B)(6) 2012, PATIENT WAS IMPLANTED WITH A TIBIA NAIL WITH PROXIMAL DUAL CORE LOCKING SCREWS AND DISTAL 5.0MM LOCKING SCREWS. PATIENT HAD A REVISION SURGERY ON (B)(6) 2013 TO HAVE THE NAIL REMOVED DUE TO NONUNION AND POSSIBILITY OF INFECTION (ANTIBIOTIC CEMENT APPLIED). WHEN REMOVING THE PROXIMAL DUAL CORE SCREWS THE MOST PROXIMAL SCREW BROKE MIDSHAFT. THE NAIL WAS REMOVED AND THE REMAINING PORTION OF THE SCREW WAS LEFT IN SITU. THE PATIENT WAS REAMED AND ANOTHER NAIL WAS IMPLANTED. 30 MINUTES WAS ADDED TO THE PROCEDURE AS A RESULT. THIS REPORT IS FOR TWO UNKNOWN DUAL CORE SCREWS. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

    Description of Event or Problem · 1

    THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    355409 HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention