ARTHRO KNOT MANIP FULL *EA

Additional Manufacturer Narrative

THIS REPORT IS BEING SUBMITTED IN PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY MITEK OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, MITEK, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. H11 ADDITIONAL NARRATIVE: INVESTIGATION SUMMARY: A PHOTO WAS RETURNED TO DEPUY SYNTHES MITEK FOR EVALUATION. THE DEPUY SYNTHES MITEK TEAM CONDUCTED A VISUAL INSPECTION OF THE RETURNED PHOTO. VISUAL ANALYSIS OF THE PHOTO REVELED THAT BOTH DEVICES, ARTHRO KNOT MANIP FULL *EA AND CORDCUTTER *EA APPEAR TO BE IN A NORMAL USED CONDITION. WITH THE PHOTO PROVIDED IS NOT POSSIBLE TO IDENTIFY A DAMAGE/FAILURE OF THE DEVICES. THE OVERALL COMPLAINT WAS UNCONFIRMED AS THE OBSERVED CONDITIONS OF THE ARTHRO KNOT MANIP FULL *EA AND CORDCUTTER *EA WOULD HAVE NOT CONTRIBUTE TO THE COMPLAINED DEVICES ISSUES.¿ BASED ON THE INVESTIGATION FINDINGS, IT WAS CONCLUDE THAT THERE IS NO ENOUGH EVIDENCE TO ADJUDICATE A ROOT CAUSE FOR THE ISSUE EXPERIENCED BY THE CUSTOMER, BOTH DEVICE NEED TO BE PHYSICALLY EVALUATED, THEREFORE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE REPORTED COMPLAINT CONDITION. AS PART OF DEPUY SYNTHES MITEK QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST-MARKET SAFETY SURVEILLANCE ACTIVITIES. DEVICE HISTORY LOT: A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE, AND NO NON-CONFORMANCES WERE IDENTIFIED.

Description of Event or Problem

IT WAS REPORTED FROM COLOMBIA THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE IT WAS OBSERVED THAT THE ARTHRO KNOT MANIP FULL *EA KNOT REMOVER CUT TWO SUTURES WHEN LOWERING THE FIRST KNOT, WHICH CAUSE A LOT OF DISCOMFORT TO THE SURGEON. IT WAS FURTHER OBSERVED THAT THE CORDCUTTER *EA DEVICE WAS VERY HARD AND DID NOT ALLOW TO CUT THE SUTURES WELL. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS IS REPORT 1 OF 2 FOR THE SAME EVENT IN (B)(4).