Arthrex® AR-5100-09Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00888867035768), received between Feb 1, 2021 and Mar 30, 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 18, 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.

• MalfunctionMar 30, 2026Break

  ON 10TH MARCH 2026, IT WAS REPORTED BY AN ARTHREX'S EMPLOYEE VIA AN EMAIL THAT FOR 1 UNIT OF AR-5100-09, GRAFTBOLT®, TIBIAL, 9 MM, ITS ANCHOR BROKE DURING INSERTION. THIS WAS DETECTED DURING A ROTATOR CUFF REPAIR AND LIGAMENT RECONSTRUCTION SURGERY ON (B)(6) 2025. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY USING ANOTHER NEW AR-5100-09. THERE WERE NO PATIENT HARM AND NO SECONDARY PROCEDURE NEEDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24715662 ↗
• MalfunctionJul 24, 2024Break; Break

  ON 1ST JULY 2024, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT FOR AN AR-5100-09, GRAFTBOLT®, TIBIAL, 9 MM, THE SHEATH WAS BROKEN. THIS WAS DETECTED DURING AN ARTHROSCOPIC ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION OF THE KNEE ON (B)(6) 2024. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AS A NEW AR-5100-09 WAS USED. THERE WAS NO PATIENT HARM AND NO SECONDARY PROCEDURE NEEDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19818739 ↗
• MalfunctionMar 13, 2023Break; Break

  ADDITIONAL INFORMATION RECEIVED ON 2/23/2023: THIS WAS DISCOVERED DURING AN ACL PROCEDURE AND COMPLETED USING ANOTHER AR-5100-09 GRAFTBOLT SCREW. ALL BROKEN PIECES WERE REMOVED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Foreign Body In Patient

  MAUDE report 16528552 ↗
• MalfunctionFeb 1, 2021Break

  IT WAS REPORTED THAT DURING A PROCEDURE, WHEN THE SURGEON WAS INSERTING THE TIBIAL GRAFTBOLT, AR-5100-09, THE SHEATH OF THE SCREW BROKE UP. THE SCREW WAS REMOVED FROM THE PATIENT AND THE CASE WAS COMPLETED WITH A SECOND TIBIAL GRAFTBOLT. NO ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11259300 ↗