BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UHN Ø6.7 L240 TAN VIOL

    MDR report key: 5439570 · Received February 16, 2016

    Report

    Report Number
    3009417901-2016-10007
    Event Type
    Injury
    Date Received
    February 16, 2016
    Date of Event
    January 24, 2016
    Report Date
    January 27, 2016
    Manufacturer
    SYNTHES SALZBURG
    Product Code
    HSB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA NOT EXPLANTED. (B)(6). DEVICE IS EXPECTED TO BE RETURNED TO SYNTHES MANUFACTURER FOR EVALUATION /INVESTIGATION, BUT HAS YET TO BE RECEIVED. DEVICE HISTORY RECORDS WAS CONDUCTED. THE REPORT INDICATES THAT THE: 462.624 / 5935585, MANUFACTURING LOCATION: (B)(4), MANUFACTURING DATE: 12 OCTOBER 2015, NO NCR'S WERE GENERATED DURING PRODUCTION THAT WOULD CONTRIBUTE TO THE COMPLAINT CONDITION. THE REVIEW OF THE DEVICE HISTORY RECORD SHOWS THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THE COMPLAINT CONDITION. 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

    A PRODUCT INVESTIGATION WAS COMPLETED: THE COUPLING AND THE FIXATION THREAD ON THE UNIVERSAL HUMERAL NAIL¿S FIXATION END FOR THE INSERTION HANDLE ARE HEAVILY DAMAGED. BESIDE OF THAT NO OTHER DAMAGE EXISTS. THE INSERTION HANDLE 358.510 WAS NOT RECEIVED FOR INVESTIGATION. THE COUPLING AND THE FIXATION THREAD ON THE UNIVERSAL HUMERAL NAIL¿S FIXATION END FOR THE INSERTION HANDLE ARE HEAVILY DAMAGED. THERE IS METAL GALLING ON THE MAJOR INSIDE DIAMETER NEAR THE DISPLACED/MISSING MATERIAL. ONE SIDE-WALL IS EVEN BENT OUTWARDS BECAUSE OF APPLIED HEAVY MECHANICAL OVERLOAD. THE FIXATION THREAD IS ALSO DAMAGED BY CROSS THREADING. ALL DESCRIBED NONCONFORMITIES/DAMAGE IS NOT RELATED TO THE MANUFACTURING PROCESS AS THE ANODIZATION LAYER HAS DISAPPEARED AND THE BLANK TITAN MATERIAL HAS BECOME VISIBLE. BECAUSE OF THE DAMAGE THE COMPLAINT RELEVANT DIMENSIONS CANNOT BE CHECKED ANYMORE FOR DIMENSIONAL ACCURACY OF THE VALID MANUFACTURING SPECIFICATIONS. A MANUFACTURING CONCLUSION CANNOT BE PRESENTED DUE TO THE CONDITION OF THE PRODUCT. VISUALLY THERE DOES NOT APPEAR TO BE AN ISSUE OTHER THAN THE DAMAGE SUSTAINED BY MECHANICAL OVERLOADING. THE ROOT CAUSE IS NOT DETERMINABLE BECAUSE OF EXISTING DAMAGE, MISSING DEVICE AND ADDITIONAL EVENT INFORMATION. NO MANUFACTURING RELATED ISSUE WAS IDENTIFIED AND/OR CONFIRMED. 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 DURING SURGERY WHEN THE SURGEON PLACED THE NAIL IN THE INSERTION HANDLE THE NAME APPEARED DEFORMED. THE NAIL WAS THEN REPLACED WITH ANOTHER ONE. THE SURGERY WAS PROLONGED ABOUT 40 MINS. THERE WAS NO PATIENT HARM. THIS REPORT IS 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    94877 UHN Ø6.7 L240 TAN VIOL ROD, FIXATION, INTRAMEDULLARY HSB SYNTHES SALZBURG 5935585

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Required Intervention