BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NAIL, FIXATION, BONE

    MDR report key: 5818898 · Received July 25, 2016

    Report

    Report Number
    2520274-2016-13620
    Event Type
    Injury
    Date Received
    July 25, 2016
    Report Date
    July 11, 2016
    Manufacturer
    SYNTHES USA
    Product Code
    JDS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). PATIENT WEIGHT IS UNKNOWN. EXACT DATE OF POST-OPERATIVE NON-UNION IS UNKNOWN. THIS REPORT IS FOR ONE (1) UNKNOWN EXPERT SPIRAL BLADE END CAP. (OTHER): WITHOUT A VALID PART AND LOT NUMBER, THE UDI IS NOT AVAILABLE. THE COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. UNKNOWN, AS SPECIFIC PART AND LOT NUMBERS FOR THE COMPLAINANT END CAP WERE NOT PROVIDED. HOWEVER, A POSSIBLE 510K IS K033071. INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED. WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORD REVIEW COULD NOT BE REQUESTED. DEVICE USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2016 DUE TO A SECONDARY FRACTURE AND NON-UNION. THE PATIENT ORIGINALLY SUSTAINED A FRACTURE OF THE LEFT HUMERUS FOLLOWING A FALL IN (B)(6) 2015. THE INJURY WAS TREATED ON (B)(6) 2015 WITH THE INSERTION OF AN EXPERT HUMERAL NAIL, A SPIRAL BLADE, AN END CAP, AND A 4.0MM LOCKING SCREW. ON AN UNKNOWN DATE IN (B)(6) 2016, THE PATIENT SUFFERED ANOTHER FALL AND RE-FRACTURED THE LEFT HUMERUS. THE NEW FRACTURE WAS DISTAL TO THE PREVIOUSLY IMPLANTED HUMERAL NAIL. THE DISTAL FRACTURED BONE, BELOW THE NAIL INSERTED, HEALED APPROPRIATELY; HOWEVER, THE HUMERUS BONE THAT CONTAINED THE ORIGINAL HUMERAL NAIL HAD NOT (NON-UNION/DELAYED HEALING). AS A RESULT, THE PATIENT WAS RETURNED TO THE OPERATING ROOM ON (B)(6) 2016 FOR AN OPEN REDUCTION INTERNAL FIXATION (ORIF) PROCEDURE UTILIZING A 6-HOLE HUMERAL PLATE WITH BONE GRAFT. THE SURGEON NOTED THAT THE ORIGINAL NAIL HAD MAINTAINED GOOD POSITION AND THAT REMOVAL WAS COMPLETED WITHOUT ISSUE. POST-OPERATIVELY, THE PATIENT WAS NOTED TO BE IN STABLE CONDITION. THIS REPORT IS FOR ONE (1) UNKNOWN EXPERT SPIRAL BLADE END CAP. THIS REPORT IS 3 OF 4 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    473040 NAIL, FIXATION, BONE JDS SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention