BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXTRACTSCR F/TIBIAL+FEM NAILS

    MDR report key: 3060964 · Received April 16, 2013

    Report

    Report Number
    8030965-2013-01667
    Event Type
    Malfunction
    Date Received
    April 16, 2013
    Date of Event
    March 14, 2013
    Report Date
    March 18, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. OUR INVESTIGATIONS HAVE SHOWN THAT THE THREAD OF THE EXTRACTION SCREW IS STRIPPED. WE SUPPOSE THAT EITHER THE THREAD HAS NOT BEEN POSITIONED - SCREWED DOWN ACCORDINGLY OR THE THREAD OF THE NAIL HAD BEEN DAMAGED PREVIOUSLY. DUE TO SEVERAL COMPLAINTS WITH THE SAME PROBLEM OUR PDC HAS DECIDED TO ENHANCE THE DESIGN AND CAPA 487 HAS BEEN INITIATED. THE THREAD IS NOW MANUFACTURED WITH ONE INSTEAD OF THREE GROVES TO GET BETTER STABILITY WHEN ENGAGED. THE NEW DESIGN IS NOW AVAILABLE. NO PRODUCT FAULT COULD BE DETECTED.

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: DURING A PROCEDURE ON (B)(6) 2013 WHILE REMOVING THE IMPLANT, THE TOP OF THE EXTRACTION SCREW BECAME DAMAGED. REPORTEDLY THERE WAS NO IMPACT TO THE PROCEDURE AND THE OPERATION WAS COMPLETED SUCCESSFULLY. NO FURTHER INFORMATION WAS PROVIDED. THIS IS 1 OF 1 REPORT FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    163145 EXTRACTSCR F/TIBIAL+FEM NAILS LXH SYNTHES GMBH 1702405

    Patients

    Seq Age Sex Outcome Treatment
    1