MalfunctionHTN
KNOTLESS T-ROPE SYN-DESMOSIS REPR TI
Received Oct 9, 2025 · Event occurred Oct 2, 2025
Report 1220246-2025-04536 · MDR key 23260296
Device
Generic name
Washer, Bolt Nut
Manufacturer
Arthrex, Inc.Model number
KNOTLESS T-ROPE SYN-DESMOSIS REPR TICatalog number
AR-8926T
Lot number
33256
Product problems
- Dull, Blunt
- Dull, Blunt
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- 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 SYNDESMOSIS STABILISATION SURGERY THE DRILL WAS DULL. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH THE SAME DEVICE. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.