BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMPRESSION FORCEPS

    MDR report key: 3070062 · Received April 22, 2013

    Report

    Report Number
    8030965-2013-10928
    Event Type
    Malfunction
    Date Received
    April 22, 2013
    Date of Event
    July 5, 2012
    Report Date
    July 5, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    HTD
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, 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. BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNAVAILABLE OR UNCHANGED. 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. 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. NO IRREGULARITIES WERE FOUND DURING THE DEVICE HISTORY RECORD REVIEW. THE PRODUCT EVALUATION VISUAL INSPECTION REVEALED THAT THE SPRING HAD BROKEN AT THE RETAINING SCREW. THE CUTTER CORRESPONDS TO THE DRAWINGS AND PROCESSES AT THE TIME OF MANUFACTURE. THIS COMPLAINT IS INVALID FROM A MANUFACTURING STANDPOINT. THE DESIGN OF THE FORCEPS WAS ASSESSED THROUGH MECHANICAL TESTING, AND PERFORMED AS INTENDED. THIS COMPLAINT IS DEEMED INVALID FROM A DESIGN PERSPECTIVE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A METATARSAL PHALANGEAL FUSION THE SURGEON WAS ABOUT TO COMPRESS THE JOINT WHEN IT WAS NOTICED THAT A PIECE HAD BROKEN OFF THE SELF RATCHETING FEATURE OF THE DEVICE. SURGEON COMPLETED PROCEDURE USING THAT SAME DEVICE BUT WITHOUT THE SELF RATCHETING FEATURE. THERE WAS NO HARM TO THE PATIENT. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172597 COMPRESSION FORCEPS HTD SYNTHES GMBH T949343

    Patients

    Seq Age Sex Outcome Treatment
    1