SCORPION-MULTIFIRE NEEDLE

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 12TH JAN 2026, IT WAS REPORTED BY AN ARTHREX'S EMPLOYEE VIA AN EMAIL THAT FOR 1 UNIT OF AR-13995N, MULTIFIRE¿ SCORPION¿ NEEDLE, IT BROKE DURING A SURGERY. THE NURSE USED THE C-ARM X-RAY MACHINE FOR IMAGING AND INSPECTION WHERE THE SURGEON REPEATEDLY EXPLORED. HOWEVER, THE SURGEON FAILED TO LOCATE THE BROKEN PART, AND IT WAS INFORMED THAT IT WAS LOST. THIS WAS DETECTED DURING A PROCEDURE ON (B)(6) 2025. THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: G3, H3, H6. THE COMPLAINT DEVICE WAS NOT RECEIVED FOR EVALUATION. 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 THE MOST LIKELY CAUSE. THE MOST LIKELY CAUSE OF THE REPORTED FAILURE IS USER ERROR, SUCH AS STRIKING BONE OR APPLYING EXCESSIVE FORCE WHEN ATTEMPTING TO PASS THE NEEDLE THROUGH FIBROUS OR CALCIFIED TISSUE, AS WARNED IN THE DIRECTIONS FOR USE. (DFU-0392-SUB). "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 COMPLAINT ALLEGATION COULD NOT BE CONFIRMED, AS THE DEVICE WAS NOT RECEIVED FOR EVALUATION, AND NO EVIDENCE OF THE REPORTED FAILURE WAS PROVIDED.