inforMED
MalfunctionMDM

SUREFIRE SCORPION NEEDLE

Received Mar 26, 2026 · Event occurred Mar 5, 2026

Report 1220246-2026-01674 · MDR key 24700010

Device

Generic name

Manual Instr, General Surgical

Manufacturer

Arthrex, Inc.

Catalog number

AR-13991N-1

Lot number

15459746

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

IT WAS REPORTED THAT DURING THE LABRUM REFIXATION, THE NEEDLE BROKE INSIDE THE PATIENT´S SHOULDER. THE BROKEN PIECES WERE COMPLETELY RETRIEVED FROM THE PATIENT. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.