UNK

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: G3, H3, H6 ARTHREX 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.

Additional Manufacturer Narrative

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

Description of Event or Problem

ON 23 JAN 2026, ARTHREX WAS NOTIFIED VIA EMAIL OF A CASE STUDY PUBLISHED ON MAY 28, 2025, BY THE FOOT AND ANKLE SURGERY JOURNAL ¿FUNCTIONAL AND RETURN-TO-SPORT OUTCOMES AFTER ARTHROSCOPIC ANATOMIC RECONSTRUCTION OF THE LATERAL LIGAMENTS OF THE ANKLE.¿ THE STUDY REVIEWED 93 PATIENTS AND IDENTIFIED ANKLE INSTABILITY WITH INTERFERENCE AND TENODESIS SCREWS IN 6 PATIENTS DURING THE 3-5 YEAR FOLLOW-UP PERIOD. IT WAS IDENTIFIED THAT 1 PATIENT EXPERIENCED A GRAFT RUPTURE AND RECURRENT INSTABILITY. REF: ANCELIN D, PHILIPPE C. FUNCTIONAL AND RETURN-TO-SPORT OUTCOMES AFTER ARTHROSCOPIC ANATOMIC RECONSTRUCTION OF THE LATERAL LIGAMENTS OF THE ANKLE. FOOT ANKLE SURG. MAY 28, 2025; DOI:10.1016/J.FAS.2025.05.010.