BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OLECRANON OSTEOTOMY END CAP

    MDR report key: 3062352 · Received April 16, 2013

    Report

    Report Number
    8030965-2013-01699
    Event Type
    Injury
    Date Received
    April 16, 2013
    Report Date
    March 21, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    HSB
    PMA / PMN Number
    K073402
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN. THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    THIS DEVICE WAS USED AS TREATMENT AND NOT DIAGNOSIS. A REVIEW OF THE PRODUCT DRAWINGS FOR THE END CAP AND NAIL INDICATE THAT THE DESIGN OF THE RETENTION FEATURE ON THE END CAP IS APPROPRIATE FOR RETENTION OF THE END CAP ON THE NAIL. UPON EXAMINING THE RETURNED END CAP, IT WAS CLEAR THAT THE RETENTION TAB WAS NOT BENT IN THE MANNER THAT IT IS SUPPOSED TO BE. IT IS UNCLEAR WHETHER THE PART WAS MANUFACTURED THIS WAY OR WHETHER SOMETHING HAPPENED INTRAOPERATIVELY TO CHANGE THE LOCATION OF THE RETENTION TAB, I.E. STRAIGHTENING THE BEND). A REVIEW OF THE RISK ANALYSIS REVEALED THAT THIS RISK WAS CAPTURED; HOWEVER, THE APPROPRIATE SEVERITY OF HARM AND RATE OF OCCURRENCE WERE NOT ASSIGNED. THIS DESIGN AND CLINICAL RISK ANALYSIS HAS BEEN REVISED TO REFLECT THE APPROPRIATE VALUES FOR SEVERITY OF HARM AND RATE OF OCCURRENCE. IN ADDITION A RISK MANAGEMENT SUMMARY FOR THIS PROJECT HAS BEEN COMPLETED. BOTH ITEMS WILL BE AVAILABLE IN (B)(4). IN CONCLUSION, IF THE RETENTION TAB HAD BEEN ORIENTED AS SHOWN ON THE PRODUCT DRAWING IT IS THE OPINION OF PRODUCT DEVELOPMENT THAT THE IMPLANT WOULD HAVE FUNCTIONED AS INTENDED. IT IS UNCLEAR WHY THE ORIENTATION OF THE RETENTION TAB IS INCORRECT; HOWEVER, IT IS CLEAR THAT IT IS NOT A RESULT OF THE DESIGN. THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 1

    PATIENT WITH LEFT DISTAL HUMERUS FRACTURE WITH OLECRANON OSTEOTOMY WAS IMPLANTED WITH OLECRANON NAIL, END CAP, TWO SCREWS AND A HUMERAL PLATE AND SCREWS ON (B)(6) 2013. ON AN UNKNOWN POST-OPERATIVE DATE, X-RAYS REVEALED THAT THE NAIL END CAP LOOSENED CAUSING THE OLECRANON OSTEOTOMY TO DISPLACE. PATIENT RETURNED TO THE OR ON (B)(6) 2013 FOR REVISION SURGERY. AT THIS TIME, END CAP WAS REMOVED, THE OSTEOTOMY SITE WAS CLEANED, NEW END CAP WAS PLACED, AND A FIVE HOLE LOCKING COMPRESSION PLATE WAS IMPLANTED FOR ROTATIONAL CONTROL. THIS IS REPORT 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    163437 OLECRANON OSTEOTOMY END CAP HSB SYNTHES GMBH 5919167

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention