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Description of Event or Problem

EVENT DESCRIPTION: ON 23 JAN 2026, ARTHREX WAS NOTIFIED VIA EMAIL OF A CASE STUDY PUBLISHED ON NOV 2021 BY THE JOURNAL OF FOOD AND ANKLE SURGERIES ¿EXTENDED DISTAL CHEVRON OSTEOTOMY AND AKIN OSTEOTOMY USING BIOABSORBABLE MATERIALS FOR TREATMENT OF MODERATE TO SEVERE HALLUX VALGUS.¿ THE STUDY REVIEWED 42 PATIENTS IDENTIFIED THAT EPIPHYSEAL DEFICIENCIES IN 1 PATIENT DURING THE 3-YEAR FOLLOW-UP FOR THE TRIM-IT PINS. IT WAS IDENTIFIED THAT 1 PATIENT EXPERIENCED DORSAL ANGULATION. REF: SONG JH, KANG C, PARK WH, ET AL. EXTENDED DISTAL CHEVRON OSTEOTOMY AND AKIN OSTEOTOMY USING BIOABSORBABLE MATERIALS FOR TREATMENT OF MODERATE TO SEVERE HALLUX VALGUS. J FOOT ANKLE SURG. NOV-DEC 2021;60(6):1110-1116. DOI:10.1053/J.JFAS.2021.01.010.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: G3, H3, H6ARTHREX WAS ABLE TO CONCLUDE A MOST LIKELY CAUSE USING THE MINIMAL INFORMATION PROVIDED, WHICH INCLUDES THE EVENT DESCRIPTION AND THE STUDY, FOR THIS CLINICAL EVENT. THE MOST LIKELY CAUSE OF THE REPORTED FAILURE CAN BE ATTRIBUTED TO A PATIENT-SPECIFIC EVENT. IF FURTHER INFORMATION IS RECEIVED, INCLUDING ADDITIONAL INFORMATION, PICTURES, VIDEOS, OR DEVICE RETURN, ARTHREX WILL REVIEW AND UPDATE THE CASE ACCORDINGLY.