BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2520274-2013-02134

    MDR report key: 3081508 · Received April 29, 2013

    Report

    Report Number
    2520274-2013-02134
    Event Type
    Injury
    Date Received
    April 29, 2013
    Report Date
    March 28, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    RETRACTING DHR RESULTS AS PREVIOUSLY REPORTED. INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED OR LOT NUMBER PROVIDED. THIS DEVICE WAS USED FOR TREATMENT NOT DIAGNOSIS.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. A REVIEW OF SYNTHES DEVICE HISTORY RECORDS FOR MANUFACTURING REVEALED NO COMPLAINT RELATED ISSUES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SURGERY FOR THE REMOVAL OF A TIBIAL NAIL WAS MADE NECESSARY BY A NON-UNION AND FIBROUS GROWTH AROUND A LINE OF FRACTURE. AN X-RAY ON AN UNKNOWN DATE REVEALED THE NON-UNION. DURING SURGERY, THE 11MM X 375MM TIBIAL NAIL WAS REMOVED ALONG WITH THREE 5MM LOCKING SCREWS. THEY WERE REPLACED WITH A 12MM X 375MM TIBIAL NAIL AND THREE 5MM LOCKING SCREWS. DURING THE REVISION SURGERY, THE SURGEON USED A 3.5 CORTICAL BLOCKING SCREW TO INSERT THE NEW 12MM TIBIAL NAIL. THE BLOCKING SCREW WAS NICKED AND A FRAGMENT CAME OFF DURING REAMING. AN X-RAY ON THE DAY OF SURGERY REVEALED THAT THE PIECE WAS SUCCESSFULLY RETRIEVED. THIS REPORT IS FOR AN UNKNOWN SCREW. THIS IS 3 OF 5 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185796 HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention