BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GAMMA NAIL 11X140 DEGREE

    MDR report key: 2190414 · Received July 28, 2011

    Report

    Report Number
    9610622-2011-00331
    Event Type
    Injury
    Date Received
    July 28, 2011
    Date of Event
    July 7, 2011
    Report Date
    July 7, 2011
    Manufacturer
    STRYKER OSTEOSYNTHESIS KIEL
    Product Code
    HSB
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADD/L INFO HAS BEEN REQUESTED. ONCE THE INVESTIGATION HAS BEEN COMPLETED ANY ADD'L INFO WILL BE REPORTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    THE PRODUCT MGR FOR TRAUMA, REPORTED THAT HE RECEIVED A TELEPHONE CALL FROM A PERSON WHO CLAIMED TO BE A SURGEON AT (B)(6) HOSP WHO ASKED FOR INFO REGARDING REHAB PROTOCOLS RELATING TO FRACTURED GAMMA NAILS. THE PRODUCT MGR PROVIDED GENERAL INFO REGARDING THE POTENTIAL ROOT CAUSES OF GAMMA NAIL FRACTURES, SUCH AS MISALIGNMENT UPON INSERTION, BUT EMPHASISED THAT SPECIFIC REHAB PROTOCOLS ARE TO BE DETERMINED SOLELY BY THE RELEVANT CONSULTANT. IN ADDITION, THE PRODUCT MGR ALSO REITERATED THAT IN ORDER TO DETERMINE THE ROOT CAUSE OF GAMMA NAIL FRACTURES, FURTHER DETAILS WOULD NEED TO BE OBTAINED, INCLUDING THE PRODUCT CODE AND LOT NUMBER OF THE DEVICE, PT DETAILS, MEDICAL HISTORY, AS WELL AS X-RAYS AND PT IMAGES. TOWARDS THE END OF THE CALL, IT WAS LATER REVEALED THAT THE PERSON CALLING WAS ACTUALLY A PT AT (B)(6) HOSP, NOT A SURGEON, WHO WAS CALLING AFTER SUFFERING FROM A GAMMA NAIL FRACTURE. THE PRODUCT MGR HAS CONTACTED THE JUNIOR DR AT THE ACCOUNT AND INFORMED HIM OF THIS DISCUSSION WITH THE PT. THE JUNIOR DR WILL ESCALATE THIS TO THE PT'S SURGEON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GAMMA NAIL 11X140 DEGREE IMPLANT HSB STRYKER OSTEOSYNTHESIS KIEL NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention