KNOTLESS MINI TR IMPLANT, 2.7MM, TI
Received Jun 8, 2026 · Event occurred May 21, 2026
Report 1220246-2026-03267 · MDR key 25427289
Device
Generic name
Washer, Bolt, Nut
Manufacturer
Arthrex, Inc.Model number
KNOTLESS MINI TR IMPLANT, 2.7MM, TICatalog number
AR-8908DS
Lot number
15546403
Product problems
- Break
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT DURING A LISFRANC REPAIR SURGERY USING KNOTLESS MINI TIGHTROPE THE DRILL HIT THE TIP OF THE CLAMP AND THE TIP OF THE DRILL BROKE. THE SURGEON REPEATED THE STEP WITH THE SECOND PACK AND THE SAME THING HAPPENED. THE FRAGMENTS WERE 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.
Additional Manufacturer Narrative
INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED UPON AVAILABILITY OF ADDITIONAL INFORMATION.