BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VEPTR NUT DRIVER SHAFT 6MM HXC

    MDR report key: 3051365 · Received April 10, 2013

    Report

    Report Number
    1719045-2013-10617
    Event Type
    Malfunction
    Date Received
    April 10, 2013
    Date of Event
    April 5, 2012
    Report Date
    April 5, 2012
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    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. 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 VEPTR NUT DRIVER SHAFT WAS MANUFACTURED BY (B)(4). THE DOWEL PIN WAS NOT ASSEMBLED ONTO THE VEPTR NUT DRIVER SHAFT ASSEMBLY. THE DOWEL PIN WAS NOT INCLUDED WITH THIS COMPLAINT. THE 11MM DIAMETER SURFACE HAD NUMEROUS SCRATCHES AND MARKS. THE DRIVER END AND THE SHAFT EXHIBITED MARKS AND SCRATCHES. THE COMPLAINT CONDITION IS DUE TO AN UNKNOWN CAUSE AND THIS COMPLAINT IS DEEMED INDETERMINATE FROM A MANUFACTURING POSITION. A PRODUCT DEVELOPMENT EVENT EVALUATION WAS ALSO PERFORMED. IT IS UNCLEAR HOW THE RIB HOOK WAS USED OR HOW IT BROKE. THEREFORE, IT IS INDETERMINATE IF THIS WAS PATIENT ACTIVITY, PATIENT ANATOMY, OR SURGEON TECHNIQUE RELATED. A DESIGN CHANGE WAS PROCESSED ON (B)(4) 2010 TO ADD AN INNER CHAMFER TO THE UPPER TAB AND MODIFY THE NOSE RADIUS. THIS CHAMFER AND RADIUS HAS INCREASED THE STRENGTH OF THIS TAB BY APPROXIMATELY 17 PERCENT. THE RIB HOOK RETURNED ON THIS COMPLAINT WAS MANUFACTURED PRIOR TO THE DESIGN CHANGE. 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.

    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.(B)(4).

    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 1 OF 2 FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    153109 VEPTR NUT DRIVER SHAFT 6MM HXC LXH SYNTHES MONUMENT 6374135

    Patients

    Seq Age Sex Outcome Treatment
    1