KNOTLESS AC TIGHTROPE OPEN REPAIR IMPLAN
Received Sep 8, 2025 · Event occurred Aug 13, 2025
Report 1220246-2025-03744 · MDR key 22993046
Device
Generic name
Washer, Bolt, Nut
Manufacturer
Arthrex, Inc.Model number
KNOTLESS AC TIGHTROPE OPEN REPAIR IMPLANCatalog number
AR-2372BLO
Lot number
15446464
Product problems
- Positioning Failure
- Detachment of Device or Device Component
- Positioning Failure
- Detachment of Device or Device Component
Patient
NA · Unknown
- Foreign Body In Patient
- No Clinical Signs, Symptoms or Conditions
- Foreign Body In Patient
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
ADDITIONAL INFORMATION: B5, D9, G3, H3, H6. BASED ON THE INFORMATION PROVIDED WHICH MAY INCLUDE THE 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 USE ERROR. THE KNOTLESS AC REPAIR SYSTEM SURGICAL TECHNIQUE, LT1-000162, OUTLINES THE FOLLOWING IN STEP 4: WITH THE BUTTON FIRMLY AGAINST THE BASE OF THE CORACOID, SEQUENTIALLY PULL ON THE FREE SUTURE LIMBS 1 CM TO 2 CM AT A TIME TO THE REDUCE THE CLAVICLE CUP BUTTON ONTO THE CLAVICLE. A HEMOSTAT OR BLUNT INSTRUMENT CAN BE PLACED UNDER THE CLAVICLE CUP BUTTON TO AID IN REDUCTION.
Description of Event or Problem
ADDITIONAL INFORMATION RECEIVED ON 9/8/2025: ALTHOUGH THE BUTTON FAILED TO HOLD THE REDUCTION, NOTHING BROKE INSIDE THE PATIENT. THE CASE EXPERIENCED A 10-MINUTE DELAY; HOWEVER, ADDITIONAL ANESTHESIA WAS NOT NEEDED.
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 8/18/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-2372BLO KNOTLESS AC TIGHTROPE DID NOT HOLD THE REDUCTION. DURING THE CASE, THE CLAVICLE AND CORACOID WERE DRILLED WITH A 3.7 MM DRILL AND THE AR-2372BLO KNOTLESS AC TIGHTROPE WAS INSERTED. THE CORACOID BUTTON WAS RELEASED FROM THE INSERTER AND CONFIRMED TO HAVE FLIPPED USING A C-ARM. THE SURGEON THEN TENSIONED THE TIGHTROPE BY PULLING ON THE FREE WHITE STRANDS, MANUALLY REDUCED THE CLAVICLE, AND TENSIONED THE CLAVICLE BUTTON DOWN TO THE SUPERIOR SURFACE. HOWEVER, UPON RELEASING MANUAL TENSION, THE BUTTON REPEATEDLY SLID BACKWARD AND FAILED TO HOLD THE REDUCTION DESPITE MULTIPLE ATTEMPTS. DUE TO CONCERNS ABOUT LOCATING THE CORACOID BUTTON, IT WAS DECIDED NOT TO REMOVE THE TIGHTROPE. INSTEAD, THE SURGEON RELEASED THE LUGGAGE TAG ON THE CLAVICLE BUTTON, FED ONE OF THE FREE TENSIONING STRANDS THROUGH THE BUTTON AND TIED A KNOT OVER THE TOP TO SECURE IT. THE IMPLANT WAS LEFT IN THE PATIENT. THIS WAS DISCOVERED DURING AN AC JOINT RECONSTRUCTION PROCEDURE ON (B)(6) 2025.
Description of Event or Problem
ADDITIONAL INFORMATION RECEIVED ON 9/8/2025: ALTHOUGH THE BUTTON FAILED TO HOLD THE REDUCTION, NOTHING BROKE INSIDE THE PATIENT. THE CASE EXPERIENCED A 10-MINUTE DELAY; HOWEVER, ADDITIONAL ANESTHESIA WAS NOT NEEDED.
Additional Manufacturer Narrative
ADDITIONAL INFORMATION: B5, G3, H3, H6. BASED ON THE INFORMATION PROVIDED WHICH MAY INCLUDE THE 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 USE ERROR. THE KNOTLESS AC REPAIR SYSTEM SURGICAL TECHNIQUE, LT1-000162, OUTLINES THE FOLLOWING IN STEP 4: WITH THE BUTTON FIRMLY AGAINST THE BASE OF THE CORACOID, SEQUENTIALLY PULL ON THE FREE SUTURE LIMBS 1 CM TO 2 CM AT A TIME TO THE REDUCE THE CLAVICLE CUP BUTTON ONTO THE CLAVICLE. A HEMOSTAT OR BLUNT INSTRUMENT CAN BE PLACED UNDER THE CLAVICLE CUP BUTTON TO AID IN REDUCTION.