SUREFIRE SCORPION NEEDLE
Received Jun 22, 2026 · Event occurred May 2, 2026
Report 1220246-2026-03512 · MDR key 25586199
Device
Generic name
Manual Instr, General Surgical
Manufacturer
Arthrex, Inc.Model number
SUREFIRE SCORPION NEEDLECatalog number
AR-13991N
Lot number
15476965
Product problems
- Break
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
ON 01-JUN-2026, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA SEMS-(B)(4) THAT AN AR-13991N SUREFIRE SCORPION NEEDLE BROKE WHEN PASSING THROUGH THE STITCH. THIS WAS DISCOVERED DURING USE WITH NO PATIENT HARM. ADDITIONAL INFORMATION WAS PROVIDED 17-JUN-2026: IT WAS FURTHER REPORTED THAT THE NEEDLE FRACTURED AT THE TIP, HOWEVER NO FRAGMENTS REMAINED INSIDE THE PATIENT. THIS OCCURRED DURING A ROTATOR CUFF REPAIR SHOULDER PROCEDURE, AND THE CASE WAS COMPLETED WITH A NEW NEEDLE. NO PROCEDURAL DELAY WAS EXPERIENCED, AND NO ADDITIONAL ANESTHESIA WAS ADMINISTERED.
Additional Manufacturer Narrative
INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED UPON AVAILABILITY OF ADDITIONAL INFORMATION.