InjuryHTN
KL AC TIGHTROPE REPAIR IMP. W/DOG BONE
Received Sep 19, 2025 · Event occurred Aug 6, 2025
Report 1220246-2025-03951 · MDR key 23095042
Device
Generic name
Washer, Bolt, Nut
Manufacturer
Arthrex, Inc.Model number
KL AC TIGHTROPE REPAIR IMP. W/DOG BONECatalog number
AR-2370BL
Lot number
15369502
Product problems
- Material Split, Cut or Torn
- Material Split, Cut or Torn
Patient
NA · Unknown
- Failure of Implant
- Failure of Implant
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 AN ACROMIOCLAVICULAR JOINT SURGERY A TIGHTROPE WAS USED. THE INITIAL SURGERY WAS PERFORMED ON (B)(6) 2025. AFTER THE SURGERY THE DEVICE TORE INSIDE THE PATIENT. THE REVISION SURGERY WAS PERFORMED ON (B)(6) 2025. THE REVISION SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER.