GRAFTS ADVANTA VXT W/GDS

Additional Manufacturer Narrative

UPON COMPLETION OF THE INVESTIGATION INTO THIS EVENT A FOLLOW UP REPORT WILL BE SUBMITTED.

Description of Event or Problem

DURING A PROCEDURE THE GRAFT BROKE WHEN USED, THERE WAS NO PATIENT HARM.

Additional Manufacturer Narrative

INVESTIGATION SUMMARY: THE INFORMATION PROVIDED INDICATES THAT THE 4-7 X45 SW NH ADVANTA VXT WITH GDS GRAFT BROKE DURING USE, THE GRAFT WAS BLOODY AND THERE WAS NO PATIENT HARM. THE GDS PORTION OF THE GRAFT WAS RETURNED. THERE WERE NO FURTHER DETAILS PROVIDED. THE DEVICE IN QUESTION WAS RECEIVED AND EVALUATED. ONLY THE GDS SECTION OF THE GRAFT WAS PROVIDED. UPON INSPECTION IT WAS CLEAR THAT THE TUNNELING SWIVEL CORE SEPARATED FROM THE SWIVEL ROD CONFIRMING THE COMPLAINT AND A DEVICE NONCONFORMANCE. THE CRIMP MARKS ON THE SWIVEL ROD WERE VERY FAINT INDICATING THAT THE CRIMP WAS NOT LIKELY SUFFICIENT DURING THE PROCESS OF MANUFACTURING. THE COMPLAINT HISTORY REVIEW IDENTIFIED 7 OTHER COMPLAINTS WHERE THE SWIVEL ROD SEPARATED FROM THE SWIVEL CORE AND 3 OTHER COMPLAINTS WHERE THERE WAS A LARGER THAN EXPECTED GAP BETWEEN THE COMPONENTS OF THE GDS. OF THE 10 COMPLAINTS, 7 OF THE INVESTIGATIONS ARE COMPLETE AND ALL 7 FOUND THE ROOT CAUSE TO BE RELATED TO THE MANUFACTURING ASSEMBLY PROCESS. FOR THE THREE COMPLAINTS RELATED TO THE GAP, THE ROOT CAUSE ALSO NOTED A CONTRIBUTING FACTOR OF DESIGN. THE EQUIPMENT USED TO CRIMP THE SWIVEL ROD ONTO THE SWIVEL CORE WAS FOUND TO BE OUT OF SPECIFICATION, RESULTING IN THE INADEQUATE CRIMP. THE ASSOCIATED NCR INVESTIGATIONS CONCLUDED THAT MACHINE IS FOUND TO BE THE MOST PROBABLE ROOT CAUSE FOR THIS NON-CONFORMANCE. INVESTIGATIONS PERFORMED PROVED THAT LOOSE FACEPLATE LEADS TO POOR CRIMPING. THE REASON FOR HAVING A LOOSE FACEPLATE COULD BE DUE TO STUD SLIPPAGE OVER TIME DUE TO MACHINE VIBRATIONS AND WEAR. IT WAS ALSO FOUND ONE OF THE ORIGINAL STUDS OF THE EQUIPMENT TO BE SHEARED TO A SHORTER LENGTH. ADDITIONALLY, METHOD IS A CONTRIBUTOR FOR THIS NCR AS THE INSPECTIONS IN PLACE ARE NOT ADEQUATE TO CATCH A NONCONFORMANCE UNDER TYPICAL USE IN THE FIELD. A RISK REVIEW FOUND THAT THE RISK MANAGEMENT DOCUMENTS FOR THIS PRODUCT ADEQUATELY ADDRESS THE REPORTED DEFECT AND THE SEVERITY AND ANTICIPATED OCCURRENCE LEVEL ARE APPROPRIATE. ACTIONS TO ADDRESS THIS ISSUE ARE ONGOING AS PER THE OUTCOME OF (B)(4).

Description of Event or Problem

N/A