Arthrex® AR-8923BCRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00888867131491), received between Apr 25, 2022 and Aug 27, 2026 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Break” (4 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 27, 2026Break

  On (b)(6) 2026, it was reported by an Arthrex employee via email that for an AR-8923BC, Suture Anchor, BioComposite PushLock®, Short, DX 2.9 x 12.5 mm, while a 2 mm SutureButton Tape was threaded through the distal eyelet, tension was applied to the tape during insertion. The eyelet fractured and detached from the device. At the time tension was applied, the eyelet was in contact with the bone. This was detected during use in unknown procedure on (b)(6) 2026. The procedure was completed successfully using a newly opened product with the same part number.No significant surgery delay reported. No additional anesthesia administered to the patient.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50473242 ↗
• MalfunctionMay 1, 2023Break; Break

  ON (B)(6) 2023, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT AN AR-8923BC BIOCOMPOSITE PUSHLOCK SHAFT BROKE WHILE INSERTING THE ANCHOR. ALL BROKEN PIECES WERE REMOVED FROM INSIDE THE PATIENT. CASE WAS COMPLETED USING ANOTHER AR-8923BC BIOCOMPOSITE PUSHLOCK. THIS WAS DISCOVERED DURING AN ATFL REPAIR ON (B)(6) 2023.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16847807 ↗
• MalfunctionJul 25, 2022Break

  ON (B)(6) 2022, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT AN AR-8923BC BIOCOMPOSITE PUSHLOCK EYELET BROKE OFF WHEN AN AR-7500 SUTURETAPE WAS PASSED THROUGH THE EYELET AND INSERTED. A NEW PRODUCT WAS USED AND CASE WAS COMPLETED WITHOUT FURTHER ISSUES. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2022.

  Patient problems: Insufficient Information

  MAUDE report 15093386 ↗
• MalfunctionApr 25, 2022Break

  ON (B)(6) 2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-8923BC BIO-COMPOSITE PUSHLOCK SUTURE ANCHOR INSERTER BROKE INSIDE THE PATIENT'S BONE. THE IMPACTOR CAP ON THE BACK OF THE PUSHLOCK BROKE BEFORE IT MET THE PURPLE PLASTIC INSERTER BODY AND A PORTION OF THE INSERTER SOMEHOW SNAPPED WITHIN THE PATIENT'S BONE, WHILE THE ANCHOR AND EYELET WAS STILL ABLE TO BE REMOVED. THE INSERTER BROKEN FRAGMENT REMAINS INSIDE THE PATIENT. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2022.

  Patient problems: Foreign Body In Patient

  MAUDE report 14192808 ↗