BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXTRACTION SCREW F/A2FN

    MDR report key: 2925682 · Received January 22, 2013

    Report

    Report Number
    8030965-2013-00185
    Event Type
    Injury
    Date Received
    January 22, 2013
    Date of Event
    November 22, 2012
    Report Date
    December 21, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWC
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. MANUFACTURING DOCUMENTS WERE REVIEWED, AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    Additional Manufacturer Narrative · 1

    AN INTERNAL INVESTIGATION WAS CONDUCTED AT SYNTHES (B)(4). THE DEVICE PASSED THE REQUIRED FUNCTIONAL TEST SUCCESSFULLY. THE EXTRACTION SCREW CAN BE CONNECTED TO THE NAIL AS INTENDED. WE WERE NOT ABLE TO REPRODUCE THE PROBLEM AS PER EVENT DESCRIPTION. THE MICROSCOPIC INVESTIGATION SHOWS MARGINAL DEFORMATION ON THE THREAD RUN-IN CAUSED DURING THE OPERATION. POSSIBLE ROOT-CAUSES ARE INSERTION OF END CAP WAS OMITTED, APPROPRIATE INCISION OR PATIENT POSITION WHICH SHOULD ALLOW ALIGNING THE EXTRACTION SCREW WITH THE NAIL OR REMAINING BONE PARTS IN THE NAIL THREAD MAY NOT HAVE BEEN REMOVED. NO PRODUCT FAULT COULD BE DETECTED.

    Description of Event or Problem · 1

    DURING SURGERY, IT WAS NOT POSSIBLE TO CONNECT THE EXTRACTION SCREW WITH THE THREAD OF THE EXPERT NAIL. AFTER SEVERAL UNSUCCESSFUL ATTEMPTS, ALSO WITH ANOTHER EXTRACTION SCREW, THE SURGEON USED A HOOKED GUIDING ROD TO REMOVE THE NAIL. THE SURGERY WAS DELAYED 2 HOURS. NO ADDITIONAL MEDICAL TREATMENT WAS REQUIRED. THIS IS # 1 OF 2 REPORTS SUBMITTED ON THIS EVENT

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    31402 EXTRACTION SCREW F/A2FN EXTRACTION SCREW HWC SYNTHES GMBH 7841013

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Required Intervention NAIL