Arthrex® AR-8906DSRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00888867373983), received between Mar 11, 2024 and Jan 23, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Positioning Failure” (2 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 23, 2025Positioning Failure; Positioning Failure

  ON 12/31/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-8906DS KNOTLESS MINI TIGHTROPE® IMPLANT SYSTEMS TIGHTROPE BUNCHED UP IN THE KNOTLESS MECHANISM. THIS OCCURRED DURING A CMC ARTHROPLASTY PROCEDURE WHERE ALL FRAGMENTS WERE REMOVED AND THE CASE CONTINUED USING A SECOND AR-8906DS KNOTLESS MINI TIGHTROPE. THERE WAS NO HARM ON THE PATIENT. THIS CAUSED NO MORE THAN A 30 SECOND DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21222845 ↗
• MalfunctionJan 2, 2025Positioning Failure; Positioning Failure

  ON 12/5/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-8906DS KNOTLESS MINI TIGHTROPE SUTURE ON THE METATARSAL SIDE WOULD NOT SHORTEN THE CONSTRUCT. THE OTHER LIMB WOULD SHORTEN, BUT ONE WOULD NOT SO THE BUTTON COULD NOT REDUCE TO THE FIRST METATARSAL. THE SUTURE WAS PULLED AGAIN AND ENDED UP SNAPPING BEFORE REDUCING AT ALL. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2024. THE CASE WAS COMPLETED BY OPENING ANOTHER AR-8906DS KNOTLESS MINI TIGHTROPE. ADDITIONAL INFORMATION RECEIVED ON 12/12/2024: THIS WAS DISCOVERED DURING A HALLUX VALGUS CORRECTION PROCEDURE. THE ANCHOR WAS REMOVED, AND THE CASE WAS DELAYED TWO MINUTES.

  Patient problems: Insufficient Information

  MAUDE report 21060750 ↗
• MalfunctionMar 11, 2024Material Twisted/Bent; Material Twisted/Bent

  ON 02/13/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA E-MAIL THAT AN AR-8906DS KNOTLESS MINI TIGHTROPE® IMPLANT BUNCHED UP WHEN SHUTTLING. THIS OCCURRED DURING A CASE WHERE THEY USED THE LINK PULL SUTURE TO SHUTTLE, NOT THE TIGHTROPE TENSIONING SUTURES.

  Patient problems: Insufficient Information

  MAUDE report 18873927 ↗