MalfunctionMDM
GUIDE PIN W/ SUTURE EYE 2.4 MM X 435 MM
Received Jul 6, 2026 · Event occurred Jun 9, 2026
Report 1220246-2026-03602 · MDR key 25715489
Device
Generic name
Manual Instr, General Surgical
Manufacturer
Arthrex, Inc.Model number
GUIDE PIN W/ SUTURE EYE 2.4 MM X 435 MMCatalog number
AR-1297LS
Lot number
UNKNOWN
Product problems
- Naturally Worn
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 THE SINGLE USE NEEDLES WERE BEING REUSED BY THE CUSTOMER AND NEED REPLACEMENT DUE TO WEAR CAUSED BY USE. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE CUSTOMER HAS BEEN INFORMED THAT THE REPORTED NEEDLES ARE SINGLE-USE ARTICLES AND WERE NOT BEING USED IN ACCORDANCE WITH THE MANUFACTURER'S INSTRUCTIONS.