BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSERTER F/TEN

    MDR report key: 3183596 · Received June 22, 2013

    Report

    Report Number
    8030965-2013-03637
    Event Type
    Malfunction
    Date Received
    June 22, 2013
    Report Date
    July 26, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    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. THEY USED THE GUIDE TO THE INPACTOR ADAPTED TO ENTER THE NAIL ON IMPACTION. MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. PLACEHOLDER.

    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. THE EVALUATION REVEALED THAT THE T-PIECE IS BROKEN APART. WE FOUND MARKS OF HEAVY HAMMER BLOWS AT THE TOP OF THE INSERTER, AT THE PLASTIC HANDLE, AT THE FOREFRONT OF THE CHUCK AND AT THE BROKEN T-PIECE ITSELF. BASED ON THESE FINDINGS WE SUPPOSE THAT THE EXCESSIVE USE CAUSED THE MALFUNCTION OF THIS DEVICE. APPLYING HIGH FORCES ONTO THE NAILS DURING THE INSERTION OF A NAIL CAN ALSO LEAD TO A JAMMING OF THE NAILS IN THE CHUCK. IN THIS RELATION WE WOULD LIKE TO MENTION PAGE 20 OF THE TECHNIQUE GUIDE WHERE IT IS STATED THAT JUST GENTLE BLOWS SHOULD BE APPLIED ONTO THE IMPACTION SURFACE OF THE INSERTER AND THAT BLOWS ON THE T-PIECE SHOULD BE AVOIDED. IF HIGHER FORCES ARE NECESSARY THE HAMMER GUIDE (359.218) CAN BE USED. HOWEVER SINCE WE RECEIVED SEVERAL SIMILAR COMPLAINTS A CAPA WAS INTRODUCED FOR THIS INSTRUMENT TO AVOID SUCH AN OCCURRENCE IN THE FUTURE. NO MANUFACTURING RELATED FAULT COULD BE DETECTED. HOWEVER, A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED.

    Description of Event or Problem · 1

    THEY USED THE GUIDE TO THE INPACTOR ADAPTED TO ENTER THE NAIL ON IMPACTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IMPACTOR OF THE NAILS BROKE DURING SURGERY WHEN THE NAIL WAS BEING INTRODUCED. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    284092 INSERTER F/TEN LXH SYNTHES GMBH 7854778

    Patients

    Seq Age Sex Outcome Treatment
    1