SUREFIRE SCORPION 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 11/27/2025, AN ARTHREX SUBSIDIARY EMPLOYEE REPORTED VIA (B)(4) THAT AN AR-13991N SUREFIRE SCORPION NEEDLE TIP BROKE DURING A SUTURE PASSAGE, AND ANOTHER SUTURE PASSER WAS USED. THE NEEDLE TIP REMAINED INSIDE THE JOINT, CAUSING A 30-MINUTE DELAY IN THE ROTATOR CUFF REPAIR PROCEDURE. ADDITIONAL INFORMATION WAS RECEIVED ON 12/05/25. THE REP ADVISED THAT IT WAS REPORTED THAT THE SURGEON WAS ATTEMPTING TO PASS THE NEEDLE THROUGH THE CUFF TO PLACE THE STITCH, WITH NO OTHER DEVICE INVOLVED AT THE TIME. THEY ATTEMPTED TO REMOVE THE FRAGMENT OF THE BROKEN NEEDLE BUT WERE UNSUCCESSFUL. THE EXACT ADDITIONAL TIME COULD NOT BE QUANTIFIED; HOWEVER, IT WAS REPORTED THAT THE SURGEON SPENT SOME TIME TRYING TO REMOVE THE FRAGMENT AND EVENTUALLY GAVE UP.

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.