PROPASS SUTURE PASSER NEEDLE

Additional Manufacturer Narrative

THIS CASE IS STILL UNDER INVESTIGATION. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON RECEIPT OF NEW AND RELEVANT INFORMATION OR UPON COMPLETION OF THE INVESTIGATION BY THE MANUFACTURING PLANT.

Description of Event or Problem

THIS REPORT IS BEING SUBMITTED IN PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ANIKA OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, ANIKA, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO A POTENTIAL PATIENT EVENT DOCUMENTED ON THIS REPORT. ON (B)(6)2024 THE DISTRIBUTOR REPORTED THAT WHEN PERFORMING A SHOULDER PROCEDURE ON A MALE PATIENT OF UNKNOWN AGE THE PROPASS NEEDLE TIP BROKE OFF IN THE PATIENT'S SHOULDER. X-RAY IMAGES INDICATED THAT THE NEEDLE FRAGMENT REMAINED IN THE PATIENT AFTER AN ATTEMPT WAS MADE TO REMOVE IT. THE SURGEON REPORTED NO CURRENT PLAN TO REMOVE THE NEEDLE FRAGMENT. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN. ADDITIONAL INFORMATION WAS SOLICITED.

Description of Event or Problem

THIS REPORT IS BEING SUBMITTED IN PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ANIKA OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, ANIKA, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO A POTENTIAL PATIENT EVENT DOCUMENTED ON THIS REPORT. ON 25JULY2024 THE DISTRIBUTOR REPORTED THAT WHEN PERFORMING A SHOULDER PROCEDURE ON A MALE PATIENT OF UNKNOWN AGE THE PROPASS NEEDLE TIP BROKE OFF IN THE PATIENT'S SHOULDER. X-RAY IMAGES INDICATED THAT THE NEEDLE FRAGMENT REMAINED IN THE PATIENT AFTER AN ATTEMPT WAS MADE TO REMOVE IT. THE SURGEON REPORTED NO CURRENT PLAN TO REMOVE THE NEEDLE FRAGMENT. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN. ADDITIONAL INFORMATION WAS SOLICITED.

Additional Manufacturer Narrative

THIS CASE IS STILL UNDER INVESTIGATION. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON RECEIPT OF NEW AND RELEVANT INFORMATION OR UPON COMPLETION OF THE INVESTIGATION BY THE MANUFACTURING PLANT. SUPPLEMENTAL REPORT: THE REPORTED EVENT WAS NOT CONFIRMED. HOWEVER THE PLAUSIBLE CAUSE WAS TRACED TO THE IFU. A NONCONFORMANCE WAS INITIATED FROM THIS COMPLAINT TO UPDATE THE PRODUCT IFU TO ADDRESS HARD TISSUE AND OR BONE WHEN THE DEVICE IS USED. A REVIEW OF THE BATCH RECORD WAS PERFORMED. THERE WAS NO NONCONFORMANCE'S IN THE BATCH RECORD. THE PRODUCT WAS MANUFACTURED TO APPLICABLE PROCEDURES AND SPECIFICATIONS. A THREE YEAR RETROSPECTIVE REVIEW AS PERFORMED FOR THE PRODUCT. THERE WAS A PREVIOUS NONCONFORMANCE ASSOCIATED TO THE REPORTED EVENT. THE NCR WAS CLOSED AS AN ISOLATED INCIDENT. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON RECEIPT OF NEW AND RELEVANT INFORMATION. THIS CASE WILL BE MONITORED AND TRENDED FOR FUTURE ANALYSIS.