BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMPRESSION FORCEPS

    MDR report key: 3071875 · Received April 22, 2013

    Report

    Report Number
    8030965-2013-10976
    Event Type
    Malfunction
    Date Received
    April 22, 2013
    Report Date
    December 15, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    HTD
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    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. ORIGINAL AWARENESS DATE IS 12/15/2011.

    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. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE MANUFACTURING EVALUATION SHOWED THAT THERE IS RUST ON THE RATCHETING MECHANISM. THE CUTTER CORRESPONDS TO THE DRAWING AND PROCESSES AT THE TIME OF MANUFACTURE. THE FORCEPS HAVE BEEN CLEANED IN THE CLOSED POSITION WHICH IS NOT RECOMMENDED, BECAUSE OF GENERAL CLEANING ISSUES.

    Description of Event or Problem · 1

    (B)(6) OFFICE REPORTED THAT SOME OF THE INSTRUMENTS OF SET 2.7 LCP VA FOREFOOT/MID-FOOT SET (01.211.220) ARE BEGINNING TO RUST. THE COMPRESSION FORCEPS ARE RUSTING AT THE LOCKING/RELEASE MECHANISM. THE PINS ARE LOOSE AND COME OUT. FORCEPS HAVE BEEN PULLED FROM SET. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171638 COMPRESSION FORCEPS HTD SYNTHES GMBH T954256

    Patients

    Seq Age Sex Outcome Treatment
    1