IMPL DELIVERY SYS,DISTAL BICEPS REPR
Received Jul 30, 2026 · Event occurred Jul 9, 2026
Report 1220246-2026-04104 · MDR key 50081598
Device
Generic name
Bone Fixation Plate
Manufacturer
Arthrex, Inc.Model number
IMPL DELIVERY SYS,DISTAL BICEPS REPRCatalog number
AR-2260
Lot number
15561356
Product problems
- Material Twisted/Bent
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
On 13-Jul-2026, a sales representative reported via email that an AR-2260 Distal Biceps Repair Implant System experienced an issue during a procedure on (b)(6) 2026. The tip of the blue-handle inserter reportedly bent and could no longer retract, preventing release and deployment of the button. All components were retrieved. The case was completed using two AR-1915FT Corkscrew FT with needle devices. No patient harm was reported.Additional information was received on 16-Jul-2026:The procedure being performed was a distal biceps repair. The inserter tip became bent during insertion, preventing successful implantation of the button. It was reported that no device components remained in the patient. The procedure was delayed by approximately 5 minutes, and an additional 5 minutes of anesthesia was administered. No patient harm was reported.
Additional Manufacturer Narrative
Investigation is in process. A follow-up report will be provided upon availability of additional information.