AC TIGHTROPE REPAIR KIT, TITANIUM
Received Apr 1, 2026 · Event occurred Mar 11, 2026
Report 1220246-2026-01764 · MDR key 24752992
Device
Generic name
Washer, Bolt, Nut
Manufacturer
Arthrex, Inc.Model number
AC TIGHTROPE REPAIR KIT, TITANIUMCatalog number
AR-2257
Lot number
34166
Product problems
- Material Split, Cut or Torn
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT DURING THE ACROMIOCLAVICULAR JOINT RECONSTRUCTION, THE SUTURE OF THE TIGHTROPE TORE DURING TENSIONING. ALL BROKEN PIECES 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.