Arthrex® AR-5100-07Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00888867035744), received between Feb 1, 2021 and Jun 26, 2025 — 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.

• MalfunctionJun 26, 2025Break; Break

  ON 5TH JUNE 2025, IT WAS REPORTED BY AN ARTHREX'S EMPLOYEE VIA EMAIL THAT FOR AN AR-5100-07, GRAFTBOLT®, TIBIAL, 7 MM, ITS ANCHOR BROKE DURING INSERTION. THIS WAS DETECTED DURING RECONSTRUCTION OF POSTERIOR FORK LIGAMENT SURGERY ON (B)(6) 2025. THE CASE WAS COMPLETED SUCCESSFULLY BY CHANGING TO A NEW AR-5100-07. THERE WAS NO PATIENT HARM, AND NO SECONDARY PROCEDURE NEEDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22336819 ↗
• MalfunctionJan 14, 2025Break; Break

  ON 24TH DECEMBER 2024, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT FOR AN AR-5100-07, GRAFTBOLT®, TIBIAL, 7 MM, THE ANCHOR BROKE DURING INSERTION. THIS WAS DETECTED DURING A RECONSTRUCTION OF POSTERIOR FORK LIGAMENT SURGERY ON (B)(6) 2024. AR-5107 WAS USED TO PREPARE THE BONE SOCKET. THE ANCHOR BROKE DURING INSERTION AND NO FRAGMENTS WERE LEFT IN THE PATIENT. PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO PATIENT HARM AND NO SECONDARY PROCEDURE NEEDED BY USING ANOTHER NEW AR-5100-07.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21149327 ↗
• MalfunctionSep 18, 2024Break; Break

  ON 4TH SEPTEMBER 2024, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT FOR AN AR-5100-07, GRAFTBOLT®, TIBIAL, 7 MM, THE SHEATH BROKE DURING INSERTION. THIS WAS DETECTED DURING USE IN AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION SURGERY ON (B)(6) 2024. THE CASE WAS COMPLETED SUCCESSFULLY USING ANOTHER NEW AR-5100-07. ALL FRAGMENTS WERE RETRIEVED FROM PATIENT. THERE WAS NO PATIENT HARM AND NO SECONDARY PROCEDURE NEEDED. AR-5108 WAS USED TO PREPARE THE BONE SOCKET.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20244848 ↗
• MalfunctionFeb 1, 2021Break

  IT WAS REPORTED THAT DURING A PROCEDURE, WHEN THE SURGEON WAS INSERTING THE TIBIAL GRAFTBOLT, AR-5100-07, 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 11259003 ↗