ARTHRO KNOT MANIP FULL *EA

Additional Manufacturer Narrative

THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY DEPUY SYNTHES, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, DEPUY SYNTHES, 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 REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. H11 ADDITIONAL NARRATIVE: THE PRODUCT WAS RETURNED TO DEPUY SYNTHES FOR EVALUATION. VISUAL INSPECTION OF THE RETURNED DEVICE FOUND THAT IT COMES IN USED CONDITION. THE SHAFT AND HANDLE HAVE NO STRUCTURAL ANOMALIES. THE DEVICE WAS VIEWED UNDER THE MICROSCOPE, AND IT WAS OBSERVED THAT THERE WAS NO DEFORMATION AT THE TIP. NO OTHER ANOMALIES WERE NOTED. A FUNCTIONAL TEST WAS PERFORMED BY PLACING A FRAGMENT OF SUTURE INSIDE THE TIP, TIGHTENING IT, AND CHECKING THAT IT DID NOT BREAK. THE OVERALL COMPLAINT WAS NOT CONFIRMED AS THE OBSERVED CONDITION OF THE ARTHRO KNOT MANIP FULL *EA WOULD NOT CONTRIBUTE TO THE COMPLAINED DEVICE ISSUE. DEVICE HISTORY REVIEW: THERE WAS NO NON-CONFORMANCE REGARDING THIS LOT. BASED ON THE FINDINGS, THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS AND NO POTENTIAL CAUSE ABOUT THE REPORTED EVENT CAN BE ESTABLISHED DUE TO THE INSUFFICIENT EVIDENCE PROVIDED. 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 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.

Additional Manufacturer Narrative

THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY DEPUY SYNTHES, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, DEPUY SYNTHES, 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 REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

Description of Event or Problem

INITIALLY IT WAS REPORTED BY SALES REP VIA PHONE THAT THE ARTHRO KNOT MANIP FULL *EA HAD AN UNSPECIFIED MALFUNCTION. IT WAS FURTHER REPORTED THAT THE DEVICE WAS CUTTING SUTURE WHEN TYING KNOTS. THE EXACT DATE OF THE EVENT WAS UNKNOWN. HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN 2026.