BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSERTER F/TEN

    MDR report key: 3193240 · Received June 27, 2013

    Report

    Report Number
    8030965-2013-03970
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Date of Event
    April 6, 2012
    Report Date
    April 10, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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). THE DHR WAS REVIEWED AND NO ISSUES THAT WOULD HAVE RESULTED IN THIS COMPLAINT WERE FOUND. THE ADDITIONAL EVALUATION VISUAL INSPECTION REVEALED THAT THE CHUCK OF THE INSERTER F/TEN IS INDEED JAMMED UP. THE DEVICE ALSO SHOWS HAMMER MARKS. BASED ON THESE FINDINGS WE SUPPOSE THAT EXCESSIVE FORCE HAS LEAD TO THE JAMMING UP OF THE CHUCK. PLEASE NOTE THAT ACCORDING TO THE SURGICAL TECHNIQUE JUST GENTLE TAPS SHOULD AFFECT DIRECTLY ON THE INSERTER AND THAT NO STRIKES ELSEWHERE ARE ALLOWED. THE MANUFACTURING RECORDS WERE REVIEWED AND NO DEVIATION TO THE SPECIFICATION WAS FOUND. NO PRODUCT FAULT COULD BE DETECTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TEN INSERTER BECAME STUCK ONTO THE TENS NAIL AND COULD NOT BE REMOVED. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    292463 INSERTER F/TEN LXH SYNTHES GMBH 3747212

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR