BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TI RIB HOOK

    MDR report key: 3052995 · Received April 11, 2013

    Report

    Report Number
    2530088-2013-10396
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Date of Event
    April 5, 2012
    Report Date
    April 5, 2012
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    MDI
    PMA / PMN Number
    H03009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, 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.(B)(4)

    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 THE DEVICE HAD POST-MANUFACTURING DAMAGE (TAB BROKEN OFF, WHICH WAS NOT RETURNED), PLUS LIGHT SCRATCHES ON THE EXTERIOR SURFACES WHICH IS CONSISTENT WITH FIELD USE. SINCE ALL RELEVANT DIMENSIONS COULD NOT BE MEASURED, THIS COMPLAINT IS INDETERMINATE FROM A MANUFACTURING POSITION. A PRODUCT DEVELOPMENT EVENT EVALUATION WAS ALSO PERFORMED. IT IS UNCLEAR HOW THE PIN FELL OUT OF THE NUT DRIVER SHAFT. THE PIN IS A K7 PRESS FIT. THIS PRESS FIT IS APPROPRIATE FOR THE NUT DRIVER USE IN CENTERING THE DRIVER OF THE NUT. THIS COMPLAINT IS INDETERMINATE AS IT IS UNCLEAR HOW THE DEVICE WAS BEING USED AT THE TIME OF THE EVENT. EXTREME FORCES OR SEVERE PATIENT ANATOMY DURING IMPLANTATION MAY CAUSE OFF AXIS LOADING OR BENDING OF THE IMPLANTS OR INSTRUMENT FOR WHICH THEY WERE NOT DESIGNED TO ACCOMMODATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A VERTICAL EXPANDABLE PROSTHETIC TITANIUM RIB (VEPTR) CASE, THE SMALL PIN IN THE VEPTR NUT DRIVER SHAFT FELL OUT WHILE THE SURGEON WAS TIGHTENING THE NUT. THE PIN WAS RETRIEVED AND SURGEON USED A BACKUP DRIVER SHAFT. A PIECE OF THE BOTTOM OF A RIB HOOK BROKE OFF AND WAS RETRIEVED. THE SURGEON USED A BACKUP RIB HOOK TO COMPLETE THE PROCEDURE WITHOUT ANY OTHER ISSUES OR HARM TO THE PATIENT. THIS IS REPORT 2 OF 2 FOR THIS EVENT.

    Description of Event or Problem · 1

    THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    155621 TI RIB HOOK MDI SYNTHES BRANDYWINE 6524121

    Patients

    Seq Age Sex Outcome Treatment
    1