UNK

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: G3, H3, H6. COMPLAINT ALLEGATION IS NOT CONFIRMED. BASED ON THE INFORMATION PROVIDED WHICH MAY INCLUDE THE DEVICE (IF AVAILABLE AND RETURNED), PICTURES, VIDEOS, EVENT DESCRIPTION, AND ANY ADDITIONAL INFORMATION FROM THE FIELD, ARTHREX WAS ABLE TO CONCLUDE A MOST LIKELY CAUSE. PER DFU-0392-SUB-EO - WARNING - TO HELP AVOID NEEDLE BREAKAGE AND POTENTIAL PATIENT INJURY: - DO NOT RESTERILIZE OR REUSE THE SCORPION¿ SUTURE PASSER NEEDLE. - AVOID STRIKING BONE OR USING EXCESSIVE FORCE TO PASS THE NEEDLE THROUGH FIBROUS/CALCIFIC TISSUE. IF EXCESSIVE FORCE IS ENCOUNTERED, REPLACE THE NEEDLE, REPOSITION THE DEVICE AND PASS IN A DIFFERENT AREA. - ENSURE A SECURE GRASP OF TISSUE TO PREVENT THE NEEDLE FROM BUCKLING UNDER THE TISSUE. - AVOID ¿DRY¿ REPETITIVE ACTUATIONS OUTSIDE THE SURGICAL SITE. ABRASION OF THE NEEDLE SURFACE CAN OCCUR THAT MAY INHIBIT PROPER FUNCTION. THE MOST LIKELY CAUSE OF THE REPORTED FAILURE CAN BE ATTRIBUTED TO USER ERROR DUE TO EXCESSIVE FORCE BEING APPLIED DURING FIRING OF THE NEEDLE, RESULTING IN THE NEEDLE BREAKING.

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 12/02/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-12990 KNEE SCORPION NEEDLE BROKE OFF INSIDE OF THE INSTRUMENT AND DID NOT COME OUT. THIS WAS DISCOVERED DURING THE CASE WITH NO PATIENT HARM.