BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIM-ARM F/AFN

    MDR report key: 3175661 · Received June 18, 2013

    Report

    Report Number
    8030965-2013-03494
    Event Type
    Malfunction
    Date Received
    June 18, 2013
    Report Date
    August 4, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. (B)(6). DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO A DEVICE MARKETED IN THE USA. MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE INVESTIGATION OF THE TOP OF THE INSERTION GUIDE HAS SHOWN THAT THE PROTECTIVE SLEEVE IS TOTALLY JAMMED. THE TIP OF THE PROTECTIVE SLEEVE IS DEFORMED. ACCORDING TO THE CURRENT DAMAGE PATTERN, THE REASON CANNOT BE DETERMINED, NEITHER HOW THE MATERIAL ABRASION WHEN ATTACHING THE DEVICE TO THE RECON-LOCK HAPPENED. THERE IS EVIDENCE THE DAMAGE TOOK PLACE BECAUSE OF SHORT TERM STRESS. NO PRODUCT FAULT COULD BE DETECTED.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: ON AN UNKNOWN DATE, THE BORE SLEEVE OF THE INSERTION GUIDE JAMMED INTEROPERATIVELY AND COULD NOT BE REMOVED. THERE WAS ABRASION WHEN INTRODUCING THE BORE SLEEVE IN FIXTURE FOR RECON LOCK. THIS IS REPORT 1 OF 3 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    275618 AIM-ARM F/AFN LXH SYNTHES GMBH 2662624

    Patients

    Seq Age Sex Outcome Treatment
    1