BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSERTER FOR TI ELASTIC NAILS

    MDR report key: 3033210 · Received April 3, 2013

    Report

    Report Number
    8030965-2013-10649
    Event Type
    Malfunction
    Date Received
    April 3, 2013
    Date of Event
    April 26, 2012
    Report Date
    April 30, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE DEVICE WAS RETURNED FOR A MANUFACTURING EVALUATION AND IT SHOWED MARKS OF FORCIBLE AND INADEQUATE USE. HAMMER BLOWS WERE VISIBLE. THE BROKEN T-HANDLE BAR WAS MISSING. IT WAS DETERMINED THAT THE DEVICE GOT DAMAGED DURING MISHANDLING AND FORCIBLE USE. THIS COMPLAINT IS DEEMED INDETERMINATE FROM A MANUFACTURING STANDPOINT.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE OPEN REDUCTION INTERNAL FIXATION OF A RADIUS PROCEDURE, THE SURGEON WAS MALLETING THE NAIL INTO THE BONE CANAL OF THE RADIUS AND THE INSERTER FOR THE TI ELASTIC NAILS BROKE. THE INSERTER WOULD NOT TIGHTEN. THE SURGEON WAS ABLE TO USE THE SECOND SET OF INSTRUMENTS TO COMPLETE THE PROCEDURE WITH NO FURTHER PROBLEMS. NO ADVERSE EFFECT TO THE PATIENT.

    Description of Event or Problem · 1

    THIS IS REPORT 1 OF 1 FOR FILE (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    135830 INSERTER FOR TI ELASTIC NAILS LXH SYNTHES GMBH 3325276

    Patients

    Seq Age Sex Outcome Treatment
    1