MalfunctionGAB
RICHARD-ALLAN® NEEDLE 1/2 CIRCLE TAPER
Received Jul 22, 2026 · Event occurred Jul 9, 2026
Report 25904376 · MDR key 25904376
Device
Generic name
Needle, Suturing, Disposable
Manufacturer
Aspen Surgical Products, Inc.Model number
216735Catalog number
216735
Lot number
400704
Patient
82 YR · Male
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
SURGEON WAS PASSING THE NEEDLE THROUGH A TENDON AND THE EYE OF THE NEEDLE BROKE OFF FROM THE REST OF THE NEEDLE. BOTH PIECES WERE RECOVERED FROM THE PATIENT.