NITINOL GUIDE PIN, 1.1 MM
Received May 18, 2026 · Event occurred Apr 28, 2026
Report 1220246-2026-02889 · MDR key 25200181
Device
Generic name
Manual Instr, General Surgical
Manufacturer
Arthrex, Inc.Model number
NITINOL GUIDE PIN, 1.1 MMCatalog number
AR-1249-1S
Lot number
15569607
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 A KNEE SURGERY THE TIP OF THE NITINOL PIN BROKE INSIDE THE PATIENT WITHOUT THE SURGEON APPLYING ANY PARTICULAR FORCE. THE BROKEN PIECE WAS RETRIEVED FROM THE PATIENT. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH THE SAME DEVICE USING THE OTHER END OF THE PIN. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.