BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSERTER F/TEN

    MDR report key: 3181097 · Received June 20, 2013

    Report

    Report Number
    8030965-2013-03732
    Event Type
    Malfunction
    Date Received
    June 20, 2013
    Report Date
    April 30, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: 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. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED. THE INVESTIGATION HAS SHOWN THAT THE HAMMERING ANVIL IS BROKEN APART. THE DEVICE SHOWS MARKS OF OFTEN AND FORCIBLE USE. WE SUPPOSE THAT 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 CAN BE USED. HOWEVER, SINCE WE HAVE HAD SIMILAR COMPLAINTS, A CAPA WAS INTRODUCED FOR THIS INSTRUMENT TO AVOID SUCH OCCURRENCE IN THE FUTURE. NO MANUFACTURING RELATED FAULT COULD BE DETECTED.

    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. MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSERTER BROKE DURING THE OPERATION. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280152 INSERTER F/TEN LXH SYNTHES GMBH 1883898

    Patients

    Seq Age Sex Outcome Treatment
    1