inforMED
MalfunctionMDM

SCORPION NEEDLE, KNEE

Received Apr 23, 2026 · Event occurred Feb 10, 2026

Report 1220246-2026-02378 · MDR key 24964890

Device

Generic name

Manual Instr, General Surgical

Manufacturer

Arthrex, Inc.

Catalog number

AR-12990N

Lot number

15529679

Product problems

  • Break

Patient

Unknown

  • Foreign Body In Patient

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 02-APR-2026, AN FDA MEDWATCH NOTIFICATION WAS RECEIVED VIA EMAIL. A FACILITY REPRESENTATIVE REPORTED THAT AN AR-12990N SCORPION NEEDLE, KNEE BROKE DURING A KNEE PROCEDURE PERFORMED ON (B)(6) 2026. THE TIP OF THE NEEDLE FRACTURED AND BECAME EMBEDDED IN THE PATIENT¿S SOFT TISSUE. A RETAINED NEEDLE FRAGMENT MEASURING APPROXIMATELY 2 MM WAS LEFT IN SITU IN THE PATIENT. ADDITIONAL INFORMATION WAS RECEIVED ON 10-APR-2026: DURING THE PROCEDURE, A HANDPIECE WAS USED WITH AN AR-12990N SCORPION NEEDLE, KNEE. APPROXIMATELY HALFWAY THROUGH THE SURGERY, THE NEEDLE FRACTURED. THE PROCEDURE WAS DELAYED FOR APPROXIMATELY 30-45 MINUTES WHILE AN X-RAY WAS OBTAINED, AND ADDITIONAL ANESTHESIA WAS ADMINISTERED DURING THIS TIME.