BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IN SITU BENDER-LEFT

    MDR report key: 3171566 · Received June 15, 2013

    Report

    Report Number
    8030965-2013-03394
    Event Type
    Malfunction
    Date Received
    June 15, 2013
    Date of Event
    September 22, 2011
    Report Date
    September 23, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    HXP
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    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. THE DEVICE LISTED IN THIS REPORT IS 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. THE DEVICE LISTED IN THIS REPORT IS USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. THE DEVICE WAS RETURNED FOR INSPECTION AND THE EVENT WAS CONFIRMED. THE EVALUATION OF THE RETURNED DEVICE REVEALED THAT THE TIP IS INDEED BROKEN. THE CROSS SECTION OF THE BROKEN SURFACE SHOWS NO IRREGULARITIES. EVIDENCE INDICATES THAT TOO MUCH MECHANICAL FORCE BEYOND THE CALCULATED DESIGN WAS APPLIED DURING BENDING WHICH CAUSED THE BREAKAGE OF THE TIP. A REVIEW OF THE DHR INDICATES THERE WERE NO ANOMALIES WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THIS COMPLAINT. THE MANUFACTURING RECORDS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. ALL RECORDS INDICATE THE PRODUCT WAS MANUFACTURED TO SPECIFICATIONS. NO PRODUCT FAULT COULD BE DETECTED. CONCLUSION ¿ THE COMPLAINT IS CONSIDERED INDETERMINATE FROM A MANUFACTURING PERSPECTIVE. THE INVESTIGATION RESULTS SHOW EVIDENCE THAT TOO MUCH MECHANICAL FORCE BEYOND THE CALCULATED DESIGN WAS APPLIED DURING BENDING WHICH CAUSED THE BREAKAGE OF THE TIP. THUS, THE DEVICE FAILURE IS RELATED TO THE CONDITIONS OF USE AND OPERATIONAL CONTEXT CONTRIBUTED TO THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TIP OF ONE OF THE BENDERS BROKE OFF. THE INSTRUMENT WAS BEING USED IN A NORMAL WAY. NO FURTHER INFORMATION WAS PROVIDED. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272435 IN SITU BENDER-LEFT HXP SYNTHES GMBH T932347

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR