BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMALL TI RIB HOOK

    MDR report key: 3247415 · Received July 25, 2013

    Report

    Report Number
    2520274-2013-04624
    Event Type
    Malfunction
    Date Received
    July 25, 2013
    Date of Event
    July 5, 2013
    Report Date
    July 5, 2013
    Manufacturer
    SYNTHES (U.S.A.) BRANDYWINE
    Product Code
    MDI
    PMA / PMN Number
    H030009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. INVESTIGATION IS ONGOING. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. NO CONCLUSION HAS BEEN DRAWN.

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: THE MANUFACTURING EVALUATION WAS CONDUCTED AND IT STATES THAT THE INSTRUMENT (SMALL TI RIB HOOK, PART NUMBER 04.641.002.1; LOT 5832089) WAS RECEIVED WITH POST MANUFACTURING DAMAGE ON THE EXTERIOR SURFACES OF THE DEVICE CONSISTING OF NICKS, SCRATCHES, AND AREAS OF MISSING ANODIZE WHICH IS CONSISTENT WITH USE. A BARREL (PART NUMBER 04.641.001.2, LOT 5852620) WAS RECEIVED WITH POST MANUFACTURING DAMAGE CONSISTING OF THE THREADED STEM BEING BROKEN IN TWO PIECES. THE NUT (PART NUMBER 04.641.001.3, LOT 5852618) WAS RECEIVED WITH POST MANUFACTURING DAMAGE CONSISTING OF THE UPPER THREADED STEM OF THE BARREL WEDGED INTO THE INTERNAL THREADS OF THE NUT. THERE WERE NO ISSUES IDENTIFIED DURING THE EVALUATION THAT ARE RELATED TO THE COMPLAINT CONDITION. BECAUSE THE COMPONENTS WERE RECEIVED WITH POST MANUFACTURING DAMAGE, NOT ALL RELATED FEATURES COULD BE VERIFIED THEREFORE THE CONCLUSION IS INDETERMINATE. A PRODUCT DEVELOPMENT EVALUATION WAS CONDUCTED AND IT STATES THAT THE IMPLANT (PART NUMBER 04.641.002) IS A SMALL RIB HOOK USED AS PART OF THE VERTICAL EXPANDABLE PROSTHETIC TITANIUM RIB (VEPTR) SYSTEM. THE VEPTR DEVICES ARE DESIGNED TO MECHANICALLY STABILIZE AND DISTRACT THE THORAX TO CORRECT DEFORMITIES. THE SYSTEM DEVICES ARE ATTACHED PERPENDICULAR TO THE PATIENT¿S NATURAL RIBS, OR THE LUMBAR VERTEBRA OF ILIUM. THE RIB HOOK IS DESIGNED TO CONNECT TO THE PROXIMAL EXTENSION TO THE PATIENT¿S RIB(S). THE RIB IS ENCIRCLED BY THE RIB HOOK AND A CAP HELD TOGETHER BY A DISTRACTION LOCK. THE PROXIMAL EXTENSION IS LOCKED BY TIGHTENING THE NUT AND BARREL ASSEMBLY OF THE RIB HOOK. UPON INSPECTION OF THE RETURNED PART, THE REPORTED CONDITION OF THREADED PORTION OF THE CONSTRUCT SHEARED OFF WAS CONFIRMED. THE BARREL BROKE OFF AND REMAINS JAMMED INSIDE THE NUT ORIFICE. CLOSER EXAMINATION REVEALS SIGNS THAT SUGGEST THAT WHEN THE PART WAS IN TORSION, IT IS POSSIBLE THAT THE NUT DRIVER (PART 03.641.003) USED WAS SLIGHTLY LEANING ON ONE SIDE AND POTENTIALLY CONTRIBUTED TO BREAK THE BARREL. THE RECEIVED IMPLANT (PART 04.641.002, LOT 6082475) REVIEW WAS COMPLETED. THE DRAWING OF INVOLVED COMPONENTS CALL OUT THE APPROPRIATE DIMENSIONS, MATERIAL AND FINISHING PROCESSES FOR A SUCCESSFUL RIB HOOK DESIGN. THE HISTORY OF DRAWING CHANGES WAS REVIEWED AND IT SHOWS THAT THE DRAWING OF AFFECTED BARREL COMPONENT PART 04.641.002.2 WAS CHANGED. THE VIEW-HOLE DIAMETER OF THE BARREL WAS REDUCED TO PROVIDE A LARGER CROSS-SECTIONAL AREA, AND THEREFORE, A STRONGER PART WHEN PLACED IN TORSION. THE RETURNED DEVICE WAS MANUFACTURED PRIOR TO THIS CHANGE. IT IS LIKELY THAT INADVERTENT NUT DRIVER LEANING ON ONE SIDE WHILE THE PART WAS IN TORSION CONTRIBUTED TO CAUSE THE CONFIRMED CONDITION IN COMBINATION WITH THE LARGE VIEW HOLE IN THE BARREL. BASED ON THIS EVALUATION, THIS COMPLAINT IS CONSISTENT WITH THE CONDITION OF THE RIB HOOK BARREL AND THEREFORE THE DISPOSITION IS DEEMED VALID FROM A DESIGN PERSPECTIVE. HOWEVER, IT IS DETERMINED THAT THE MOST RECENT DESIGN OF RIB HOOK PART 04.641.002 IS ADEQUATE FOR ITS INTENDED USE. IT IS LIKELY THAT INADVERTENT NUT DRIVER LEANING ON ONE SIDE WHILE THE PART WAS IN TORSION CONTRIBUTED TO CAUSE THE CONFIRMED CONDITION IN COMBINATION WITH THE LARGE VIEW HOLE IN THE BARREL. (B)(4). DEVICE USED FOR TREATMENT NOT DIAGNOSIS. THE 510K: REPORTED INCORRECTLY, IT SHOULD BE H030009.

    Description of Event or Problem · 1

    DURING A PLANNED VERTICAL EXPANDABLE PROSTHETIC TITANIUM RIB II (VEPTR II) EXCHANGE IN (B)(6), THE SURGEON WAS ATTEMPTING TO LOOSEN THE LOCKING NUT ON THE SMALL RIB HOOK TO EXCHANGE THE VEPTR II ROD, WHEN THE THREADED PORTION OF THE LOCKING CONSTRUCT SHEARED OFF. IN ADDITION, THE CENTERING PIN OF THE VEPTR NUT DRIVER SHAFT BROKE OFF. ALL PIECES WERE RETRIEVED. THERE WAS REPORTEDLY NO EXCESSIVE FORCE USED IN ATTEMPTING TO RELEASE THE NUT. THERE WAS A MINOR DELAY (REPORTED AS 1 TO 2 MINUTES) AS THE SMALL RIB HOOK NEEDED TO BE EXCHANGED FOR A NEW ONE. THE INTENDED SMALL RIB HOOK CAP WAS MAINTAINED. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    347422 SMALL TI RIB HOOK MDI SYNTHES (U.S.A.) BRANDYWINE 6082475

    Patients

    Seq Age Sex Outcome Treatment
    1