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 ON THE FOURTH SUTURE PASS DURING A ROTATOR CUFF REPAIR PROCEDURE. NO PATIENT WAS AFFECTED.

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, INCLUDING 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). THE COMPLAINT ALLEGATION WAS CONFIRMED UPON REVIEWING THE CUSTOMER'S ATTACHED PICTURE, WHICH DISPLAYED AN AR-13991N SUREFIRE SCORPION NEEDLE WITH THE TIP BROKEN OFF.