KNOTLESS AC TIGHTROPE OPEN REPAIR IMPLAN
Received Aug 21, 2025 · Event occurred Aug 5, 2025
Report 1220246-2025-03569 · MDR key 22859834
Device
Generic name
Washer, Bolt, Nut
Manufacturer
Arthrex, Inc.Model number
KNOTLESS AC TIGHTROPE OPEN REPAIR IMPLANCatalog number
AR-2372BLO
Lot number
15244165
Product problems
- Premature Activation
- Premature Activation
Patient
NA · Unknown
- Insufficient Information
- Insufficient Information
Narrative
Description of Event or Problem
ON 08/05/2025, A SALES REPRESENTATIVE REPORTED VIA (B)(4) THAT (2) AR-2372BLO KNOTLESS AC TIGHTROPE® OPEN REPAIR IMPLANTS PEC BUTTON DEPLOYED TOO EARLY BOTH TIMES. THIS OCCURRED DURING USE.
Additional Manufacturer Narrative
INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED UPON AVAILABILITY OF ADDITIONAL INFORMATION.
Additional Manufacturer Narrative
ADDITIONAL INFORMATION: G3, H3, H6. COMPLAINT ALLEGATION IS NOT CONFIRMED. BASED ON THE INFORMATION PROVIDED WHICH MAY INCLUDE THE DEVICE (IF AVAILABLE AND RETURNED), PICTURES, VIDEOS, EVENT DESCRIPTION, AND ANY ADDITIONAL INFORMATION FROM THE FIELD, ARTHREX WAS ABLE TO CONCLUDE A MOST LIKELY CAUSE. THE MOST LIKELY CAUSE FOR THE REPORTED FAILURE CAN BE ATTRIBUTED TO USER ERROR OF THE DEVICE DUE TO MISALIGNMENT INSERTION, AND/OR PRYING/LEVERAGING OF THE DEVICE DURING INSERTION.