PHOTODYNAMIC BONE STABILIZATION SYSTEM

Description of Event or Problem

BALL TIP FROM 2.0 BALL TIP GUIDE WIRE SEPARATED FROM THE SHAFT. BALL TIP WAS LEFT IN THE PELVIS.

Additional Manufacturer Narrative

ROOT CAUSE INVESTIGATION: DHR REVIEW: THE DHR WAS REVIEWED AND FOUND TO BE IN SPECIFICATION AT THE TIME OF MANUFACTURE AND RELEASE. IT IS NOTED THAT THE CONSTRUCTION OF THE BALL TIPPED GUIDEWIRE IS A TWO PIECE CONSTRUCTION, IN WHICH THE BALL TIP IS WELDED TO THE SHAFT BY SUPPLIER. AN INSUFFICIENT WELD BETWEEN THE BALL TIP AND THE SHAFT COULD CAUSE THE FAILURE MODE OBSERVED IN THIS COMPLAINT. RETURNED PRODUCT EVALUATION: THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE BALL TIP REMAINS IN THE PATIENT. TESTING REVIEW: THE TESTING FOR THE 2.0MM BALL TIPPED GUIDEWIRE BALL TIP BREAK FORCE WAS REVIEWED. TESTING DEMONSTRATED THE PEAK TENSILE BREAK FORCE OF THE BALL TIPPED GUIDEWIRE FROM THE SHAFT MET THE CRITERIA OF AVERAGE PEAK TENSILE FAILURE LOAD OF 445N (100 LBS) AND THE LOWER CONTROL LIMIT MET THE CRITERIA OF 356N (80LBS). THE TIPS DID NOT FAIL AFTER THE APPLICATION OF MORE THAN 3425N (770 LBS). IN THIS COMPLAINT THE BALL TIP FELL OFF THE GUIDEWIRE WITHOUT A SIGNIFICANT APPLICATION OF FORCE, WHICH SUGGESTS THAT THE DEVICE FAILURE WAS DUE TO A MANUFACTURING PROCESS ISSUE IN WHICH COULD LEAD TO THE BALL TIP BREAK FORCE SPECIFICATION NOT BEING MET FOR THIS DEVICE. IFU REVIEW: THE IFU 900356_X STATES THAT RISKS INCLUDE INABILITY TO PROPERLY DEPLOY OR REMOVE DEVICE. THE STG FOR PELVIS 900598_A INCLUDES INSTRUCTIONS TO USE THE FLEXIBLE BURRS OR REAMER WITH THE APPROPRIATE BALL TIP GUIDE WIRE. POTENTIAL FOR USER ERROR: THERE IS NO INDICATION THAT USER ERROR CONTRIBUTED TO THIS EVENT. FOLLOW UP INFORMATION FROM THE SALES REP PRESENT DURING THE CASE IDENTIFIED THAT NO SIGNIFICANT FORCES WERE APPLIED PRIOR TO THE BALL TIP SEPARATING FROM THE GUIDEWIRE, IT WAS BEING USED AS NORMAL MOVING FORWARD AND BACKWARD. PREVIOUS INVESTIGATIONS: CAPA-1175 WAS OPENED TO INVESTIGATE CIR-0229 AND CIR-0232 WHICH HAD THE SAME FAILURE MODE OF THE BALL TIP SEPARATING FROM THE GUIDEWIRE DURING USE. CAPA-1175 IDENTIFIED THE ROOT CAUSE WAS POST-WELD OVER PROCESSING OF THE BALL TIPPED GUIDEWIRE TO INCLUDE CHAMFER ON WELD BEAD WHICH CAUSES THE BALL TIP TO SEPARATE FROM THE SHAFT DURING USE DUE TO A THIN WELD BY THE SUPPLIER. THE SUPPLIER HAS THIS POTENTIAL FAILURE MODE CAPTURED IN THEIR PFMEA#250 FOR THE MANUAL LATHE PROCESS RESULTING IN EITHER OVER OR UNDERSIZED WELD (ROW 1). CORRECTIVE ACTIONS WERE IMPLEMENTED IN CAPA-1175 TO ADDRESS THE ROOT CAUSE. THIS DEVICE WAS MANUFACTURED PRIOR TO THE IMPLEMENTATION OF CORRECTIVE ACTIONS BY THE SUPLLIER. RISK REVIEW PERFORMED USING FMEA & PMS ANALYSIS: THE FAILURE WAS IDENTIFIED DUE TO OVER PROCESSING OF THE WELD BY THE SUPPLIER OF THE BALL TIPPED GUIDEWIRE COMPONENT, FIVE STAR. FIVE STAR HAS THE FAILURE MODE AND CAUSE CAPTURED IN PFMEA#250 ROW 1 AND WAS NOTIFIED OF THIS OCCURRENCE. ILLUMINOSS HAS THE FAILURE OF GUIDEWIRE BENDS OR BREAKS (DMFEA-1002 ROW 515), WITH POTENTIAL PATIENT HARM OF MAY NEED TO REMOVE GUIDEWIRE FROM PATIENT AND A SEVERITY OF 4. MAY NEED TO RETRIEVE DETACHED PIECE OF INSTRUMENT. INSTRUMENT MAY BE RETAINED IN PATIENT. MAY NEED TO OBTAIN ALTERNATIVE GUIDEWIRE. MAY LEAD TO SURGICAL DELAY, WHICH CAPTURES THE PATIENT EFFECT IN THIS COMPLAINT BECAUSE THE INSTRUMENT WAS RETAINED IN THE PATIENT AND THERE MAY HAVE BEEN SURGICAL DELAY. WHILE THIS DFMEA ROW DOES NOT CAPTURE THE CAUSE OF THE COMPLAINT, BECAUSE IT WAS MANUFACTURING RELATED AND SUPPLIER MAINTAINS THE FMEA, THE POTENTIAL PATIENT EFFECT AND SEVERITY IS STILL CAPTURED IN THE ILLUMINOSS RISK DOCUMENTATION. CONCLUSION: THE ROOT CAUSE OF THE BALL TIP SEPARATING FROM THE GUIDEWIRE IS DUE TO POST-WELD OVER PROCESSING OF THE BALL TIPPED GUIDEWIRE TO INCLUDE A CHAMFER ON THE WELD BREAD RESULTING IN A THIN WELD BY THE SUPPLIER.