KNOTLESS AC TIGHTROPE OPEN REPAIR IMPLAN
Received Oct 7, 2025 · Event occurred Sep 30, 2025
Report 1220246-2025-04491 · MDR key 23237993
Device
Generic name
Washer, Bolt, Nut
Manufacturer
Arthrex, Inc.Model number
KNOTLESS AC TIGHTROPE OPEN REPAIR IMPLANCatalog number
AR-2372BLO
Lot number
15296156
Product problems
- Break
- Detachment of Device or Device Component
- Break
- Detachment of Device or Device Component
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
ON 09/30/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-2372BLO KNOTLESS AC TIGHTROPE BUTTON CAME OFF THE INSERTER WHEN GOING THROUGH THE CLAVICLE. THE INSERTER WAS RETRIEVED TO INSPECT AND THE STYLET BROKE OFF OUTSIDE THE PATIENT. IMPLANT WAS ABLE TO BE RETREIVED. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT. 10 MINUTE DELAY TO CASE. CASE WAS COMPLETED USING A SECOND IMPLANT.
Additional Manufacturer Narrative
ADDITIONAL INFORMATION: G3, H3, H6. 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 CAN BE ATTRIBUTED MISUSE DUE TO MISALIGNED INSERTION; OR PRYING/LEVERAGING THE SCREW DURING INSERTION.