SUREFIRE SCORPION NEEDLE
Received Feb 16, 2026 · Event occurred Jan 28, 2026
Report 1220246-2026-00602 · MDR key 24344353
Device
Generic name
Manual Instr, General Surgical
Manufacturer
Arthrex, Inc.Model number
SUREFIRE SCORPION NEEDLECatalog number
AR-13991N
Lot number
15408528
Product problems
- Break
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
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 28-JAN-2026, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA (B)(4) THAT AN AR-13991N SUREFIRE SCORPION NEEDLE TIP BROKE DURING SUTURE PASSAGE THROUGH THE ROTATOR CUFF. THIS WAS DISCOVERED DURING A SINGLE-ROW TECHNIQUE PROCEDURE WITH NO PATIENT HARM. THE CASE WAS COMPLETED WITH ANOTHER NEEDLE. IT WAS FURTHER REPORTED THAT THEY BELIEVE THE SURGEON MAY HAVE ENCOUNTERED SOME RESISTANCE DURING THE PASSAGE AND ENDED UP APPLYING FORCE, WHICH CAUSED THE BREAKAGE. THE BONE QUALITY WAS REPORTED AS CANCELLOUS BONE AND NO FRAGMENT REMAINED IN THE PATIENT.