BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_TRAUMA_AND_EXTREMITY_PRODUCT

    MDR report key: 4213641 · Received October 30, 2014

    Report

    Report Number
    0008031020-2014-00517
    Event Type
    Injury
    Date Received
    October 30, 2014
    Date of Event
    June 27, 2014
    Report Date
    September 16, 2014
    Manufacturer
    STRYKER TRAUMA SELZACH
    Product Code
    HTY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WILL NOT BE RETURNED. ADDITIONAL INFORMATION WAS REQUESTED AND IF RECEIVED WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: SUBCLINICAL NERVE DAMAGE MAY POSSIBLY OCCUR AS A RESULT OF THE SURGICAL TRAUMA, THEREFORE THE REPORTED FAILURE APPEARS TO BE DEVICE UNRELATED PATIENT/MEDICAL/SURGICAL CONDITIONS. AS PER IFUS A DAMAGE TO THE NERVE IS A COMPLICATION ASSOCIATED WITH THE SURGERY ITSELF. BASED ON CURRENTLY AVAILABLE INFORMATION IT IS UNKNOWN WHAT ANATOMICAL SEGMENT HAS BEEN TREATED, THE SURGICAL APPROACH AND THE IMPLANTED DEVICE. FURTHERMORE, AS PER VARIAX ELBOW PLATING SYSTEM TECHNIQUES SPECIAL CARE HAS TO BE TAKEN IN ORDER TO NOT DAMAGE THE ULNAR NERVE. THE ULNAR NERVE SHOULD BE EXPLORED AND PROTECTED AS PART OF THE SURGICAL APPROACH AND THE RADIAL NERVE MAY REQUIRE EXPLORATION WITH PROXIMAL SHAFT EXTENSION (SEE ORIGINAL STATEMENTS). AN UNINTENDED DEVIATION FROM HE SURGICAL TECHNIQUE COULD NEITHER BE EXCLUDED NOR CONFIRMED. MORE DETAILED INFORMATION ABOUT THE COMPLAINT EVENT AS WELL AS THE AFFECTED DEVICE MUST BE AVAILABLE IN ORDER TO DETERMINE THE ROOT CAUSE OF THE COMPLAINT EVENT. IF THE DEVICE IS RETURNED OR IF ANY ADDITIONAL INFORMATION IS PROVIDED, THE INVESTIGATION WILL BE REASSESSED. A DEVICE INVESTIGATION WAS NOT POSSIBLE, SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY WAS NOT POSSIBLE BECAUSE THE LOT NUMBER WAS NOT COMMUNICATED. A REVIEW OF THE LABELING DID NOT INDICATE ANY ABNORMALITIES. NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME. IFU VARIAX ELBOW PLATING SYSTEM ADVERSE EFFECTS IN MANY INSTANCES, ADVERSE RESULTS MAY BE CLINICALLY RELATED RATHER THAN DEVICE RELATED. THE FOLLOWING ARE THE MOST FREQUENT ADVERSE EFFECTS INVOLVING THE USE OF INTERNAL FRACTURE FIXATION DEVICES, SUBCLINICAL NERVE DAMAGE MAY POSSIBLY OCCUR AS A RESULT OF THE SURGICAL TRAUMA. CARE IS TAKEN NOT TO DAMAGE THE ULNAR NERVE.

    Description of Event or Problem · 1

    THE PATIENT UNDERWENT THE SURGERY WITH THE VARIAX ELBOW PLATE. AFTERWARDS, ALTHOUGH THE BONE UNION OF THE FRACTURE PART WAS SEEN, PARESTHESIA OCCURRED IN ULNAR NERVE. THIS CASE WAS ACQUIRED FROM THE (B)(6) REPAIR CASE 2.

    Description of Event or Problem · 1

    THE PATIENT UNDERWENT THE SURGERY WITH THE VARIAX ELBOW PLATE. AFTERWARDS, ALTHOUGH THE BONE UNION OF THE FRACTURE PART WAS SEEN, PARESTHESIA OCCURRED IN ULNAR NERVE. THIS CASE WAS ACQUIRED FROM THE JOURNAL OF (B)(4) SOCIETY FOR FRACTURE REPAIR (2 CASE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    695793 UNKNOWN_TRAUMA_AND_EXTREMITY_PRODUCT IMPLANT HTY STRYKER TRAUMA SELZACH UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention