inforMED
MalfunctionMDM

SCORPION-MULTIFIRE NEEDLE

Received Jun 12, 2026 · Event occurred Apr 15, 2026

Report 1220246-2026-03389 · MDR key 25490897

Device

Generic name

Manual Instr, General Surgical

Manufacturer

Arthrex, Inc.

Catalog number

AR-13995N

Lot number

15392935

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 27-MAY-2026, A COMPETENT AUTHORITY REPORTED VIA EMAIL THAT AN ISSUE OCCURRED WITH AN AR-13995N MULTIFIRE SCORPION NEEDLE ON (B)(6) 2026. MINIMAL HARM WAS REPORTED, AND NO ADDITIONAL INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION WAS RECEIVED ON 03-JUN-2026: ON 03-JUN-2026, A COMPETENT AUTHORITY REPORTED VIA EMAIL THAT AN AR-13995N MULTIFIRE SCORPION NEEDLE WAS USED DURING A SURGICAL PROCEDURE. AFTER SEVERAL USES, THE TIP OF THE DEVICE WAS OBSERVED TO HAVE BROKEN OFF IN THE PATIENT¿S SHOULDER. THE REPORTED FRAGMENT SIZE WAS LESS THAN 1 MM. THE SURGEON ATTEMPTED TO SURGICALLY LOCATE AND RETRIEVE THE FRAGMENT; HOWEVER, RETRIEVAL WAS UNSUCCESSFUL. A REPLACEMENT SCORPION DEVICE WAS OPENED, AND THE PROCEDURE WAS COMPLETED.