inforMED
MalfunctionHTN

KNOTLESS AC TIGHTROPE OPEN REPAIR IMPLAN

Received Apr 10, 2026 · Event occurred Mar 17, 2026

Report 1220246-2026-02148 · MDR key 24844815

Device

Generic name

Washer, Bolt, Nut

Manufacturer

Arthrex, Inc.

Catalog number

AR-2372BLO

Lot number

15516192

Product problems

  • Detachment of Device or Device Component

Patient

NA · Unknown

  • 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

IT WAS REPORTED THAT DURING AN ACROMIOCLAVICULAR SEPARATION SURGERY THE BUTTON OF THE TIGHTROPE FELL FROM THE IMPLANT HOLDER AFTER PASSING THROUGH THE CLAVICLE TWICE. 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.