BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UHN Ø6.7 L280 TAN VIOL

    MDR report key: 5745470 · Received June 23, 2016

    Report

    Report Number
    3009417901-2016-10018
    Event Type
    Injury
    Date Received
    June 23, 2016
    Date of Event
    June 5, 2016
    Report Date
    June 8, 2016
    Manufacturer
    SYNTHES SALZBURG
    Product Code
    JDS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION IS UNKNOWN. DEVICE WAS NOT IMPLANTED/EXPLANTED. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. (B)(6). DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. MANUFACTURING LOCATION: (B)(4), SUPPLIER: (B)(4). MANUFACTURING DATE: AUGUST 19, 2013. NO NON-CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. DEVICE WAS 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.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. A PRODUCT DEVELOPMENT INVESTIGATION WAS PERFORMED FOR THE COMPLAINT DEVICE (UHN Ø6.7 L280 TAN VIOL, PART NUMBER 462.628, LOT NUMBER 5924715). THE COMPLAINT DEVICE WAS RECEIVED WITH LIGHT SCRATCHES LOCATED DISTALLY AND PROXIMALLY FROM NORMAL USE. NAIL DIMENSIONS CONFIRMED TO SPECIFICATIONS AS Ø6.62 X 280 MM. NO DEFORMATIONS, TRACES OF MISUSE OR ANY EVIDENCE POTENTIALLY EXPLAINING THE REPORTED HARM WERE OBSERVED. BASED UPON THE DESCRIPTION OF THE COMPLAINT REPORT THERE ARE SEVERAL POSSIBLE ROOT CAUSES FOR THE INCIDENT. NO X-RAY IMAGES AND PATIENT DATA SUCH AS AGE, SIZE, WEIGHT, AND BONE QUALITY WERE MADE AVAILABLE TO SUPPORT POTENTIAL FINDINGS. IN SUMMARY, THE AVAILABLE DATA AND PRODUCT DOES NOT ALLOW A MEANINGFUL STATEMENT. FOR CONCLUSIVE FINDINGS MORE EVIDENCE MUST BE MADE AVAILABLE. THE COMPLAINT IS UNCONFIRMED. 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

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE PATIENT HAS A CROSS-DISPLACED FRACTURE IN THE MIDDLE THIRD OF THE LEFT DISTAL HUMERUS WHICH WAS TREATED ON JUNE 05, 2016. WHEN THE SURGEON USED THE SOLID HUMERAL NAIL (UHN) THE FRACTURE BECAME COMMINUTED. DUE TO THIS SITUATION, THE SURGEON USED PRODUCTS FROM ANOTHER MANUFACTURER TO COMPLETE THE PROCEDURE; NO SYNTHES DEVICES WERE IMPLANTED. THE SURGERY WAS PROLONGED FOR SIXTY (60) MINUTES WHILE GETTING THE NEW EQUIPMENT. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    399871 UHN Ø6.7 L280 TAN VIOL NAIL, FIXATION, BONE JDS SYNTHES SALZBURG 5924715

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention