K-LESS T-ROPE W/DRV IMP ONLY,SYN REPR,TI
Received Oct 24, 2025 · Event occurred Oct 16, 2025
Report 1220246-2025-04801 · MDR key 23378129
Device
Generic name
Washer, Bolt, Nut
Manufacturer
Arthrex, Inc.Model number
K-LESS T-ROPE W/DRV IMP ONLY,SYN REPR,TICatalog number
AR-8925T-01
Lot number
15432794
Product problems
- Positioning Failure
- Positioning Failure
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 LIGAMENT SURGERY WITH A TIGHTROPE THE BUTTON DID NOT FLIP ON THE TIBIA AND MOVED BACK INTO THE DRILL CHANNEL. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH A DIFFERENT PART NUMBER (AR-8926T). IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.