KNOTLESS AC TIGHTROPE OPEN REPAIR IMPLAN
Received Mar 12, 2026 · Event occurred Feb 17, 2026
Report 1220246-2026-01351 · MDR key 24578538
Device
Generic name
Washer, Bolt, Nut
Manufacturer
Arthrex, Inc.Model number
KNOTLESS AC TIGHTROPE OPEN REPAIR IMPLANCatalog number
AR-2372BLO
Lot number
15500856
Product problems
- Device Dislodged or Dislocated
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT DURING THE ACROMIOCLAVICULAR JOINT REPAIR, THE BUTTON OF THE FIRST AR-2372BLO (15500856) DID NOT FLIP AND THE BUTTON WAS PULLED OUT. THE SECOND AR-2372BLO (15474037) HAVE A FAILURE WITH THE SHAFT, SO THEY COULD NOT INSERT THE BUTTON. THEY USED A DIFFERENT SHAFT FROM ANOTHER AR-2372BLO TO INSERT THE BUTTON. 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.