UNK

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: D6B, G3, H3, H6 BASED ON THE INFORMATION PROVIDED ¿ WHICH MAY INCLUDE CLINICAL REPORTS, FOLLOW-UP DOCUMENTATION, EVENT DESCRIPTIONS, AND ANY ADDITIONAL SITE INPUT ¿ ARTHREX HAS DETERMINED THE MOST LIKELY CAUSE. THE MOST LIKELY CAUSE CAN BE ATTRIBUTED TO PATIENT-SPECIFIC FACTORS, INCLUDING IMPAIRED WOUND HEALING ASSOCIATED WITH CONTINUED SMOKING AND PERSISTENT WOUND COMPLICATIONS.

Description of Event or Problem

ON (B)(6) 2025, A CLINDEX NOTIFICATION WAS RECEIVED INDICATING THAT A SUBJECT LISTED IN THE FOOT AND ANKLE REGISTRY EXPERIENCED MEDIAL ANKLE WOUND DEHISCENCE. THE PATIENT WAS TAKEN TO THE OPERATING ROOM FOR IRRIGATION AND DEBRIDEMENT, AND MEDIAL ANKLE HARDWARE WAS REMOVED. A SKIN MATRIX WAS APPLIED TO ENCOURAGE HEALING, WHILE THE STUDY HARDWARE WAS RETAINED. THE ONSET DATE OF THIS ISSUE WAS 07/17/2025. THE WOUND COMPLICATION PERSISTED AND WAS NOTED AS A SIGNIFICANT ONGOING ISSUE. THE PATIENT CONTINUES TO SMOKE. THE PATIENT WAS SUBSEQUENTLY RECOMMENDED FOR FULL HARDWARE REMOVAL AND SECONDARY WOUND CLOSURE. THE PATIENT WAS WITHDRAWN FROM THE STUDY DUE TO COMPLICATIONS AND HARDWARE REMOVAL, WITH THE ONSET OF THIS EVENT ON 11/04/2025. THE EVENT WAS INDICATED AS UNRELATED TO THE ANKLE FRACTURE FIXATION PRODUCTS IMPLANTED ON (B)(6) 2025.

Additional Manufacturer Narrative

INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED UPON AVAILABILITY OF ADDITIONAL INFORMATION.