Arthrex® AR-5207Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00888867265813), received between Jun 14, 2021 and May 15, 2025 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Break” (7 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 15, 2025Break; Break

  ON 04/23/2025, AN ARTHREX SUBSIDIARY EMPLOYEE REPORTED VIA EMAIL THAT AN AR-5207 TENSIONLOC COLLAR AND PLUG IMPLANT HAD A BROKEN COLLAR WHEN INSERTED. THE BROKEN PIECES WERE RETRIEVED FROM THE PATIENT. THE CASE WAS COMPLETED USING ANOTHER AR-5207 TENSIONLOC COLLAR AND PLUG IMPLANT. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2025, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22030371 ↗
• MalfunctionMay 1, 2025Break; Break

  ON 4/3/2025, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT THE COLLAR FROM AN AR-5207 TENSIONLOC COLLAR AND PLUG CRACKED WHEN THE PLUG WAS HAMMERED IN. ALL THE BROKEN FRAGMENTS WERE REMOVED. THE CASE WAS COMPLETED USING ANOTHER AR-5207 TENSIONLOC COLLAR AND PLUG. THIS WAS DISCOVERED DURING A PCL RECONSTRUCTION PROCEDURE ON (B)(6) 2025.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21942112 ↗
• MalfunctionJan 24, 2024Break; Break

  ON 01/05/2024, IT WAS REPORTED BY A ARTHREX EMPLOYEE VIA EMAIL THAT AN AR-5207 TENSION LOCK COLLAR WAS BROKEN WHILE MALLETING. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18573892 ↗
• MalfunctionJan 24, 2024Break; Break

  ON 01/05/2024, IT WAS REPORTED BY A ARTHREX EMPLOYEE VIA EMAIL THAT AN AR-5207 TENSION LOCK COLLAR WAS BROKEN WHILE MALLETING. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18573749 ↗
• MalfunctionNov 9, 2022Break

  ON (B)(6) 2022, IT WAS REPORTED BY A ARTHREX EMPLOYEE VIA EMAIL THAT AN AR-5207 TENSIONLOC COLLAR AND PLUG IMPLANT BROKE DURING INSERTION. ALL BROKEN FRAGMENTS WERE RETRIEVED AND A NEW AR-5207 TENSIONLOC COLLAR AND PLUG IMPLANT WAS USED TO COMPLETE THE CASE. THIS WAS DISCOVERED DURING AN ACLR PROCEDURE ON (B)(6) 2022.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15758790 ↗
• MalfunctionMay 19, 2022Break

  ON (B)(6) 2021 IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT AN AR-5207 TENSION-LOC COLLAR BROKE WHEN SURGEON IMPACTED IMPLANT DURING THE TIBIAL FIXATION. THIS WAS DISCOVERED DURING AN ACL RECONSTRUCTION ON (B)(6) 2021. ALL BROKEN FRAGMENTS WERE RETRIEVE AND PATIENT WAS NOT AFFECTED. A NEW DEVICE WAS USED TO COMPLETE CASE SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14435496 ↗
• MalfunctionNov 2, 2021Material Separation

  ON 10/05/2021 IT WAS REPORTED BY A ARTHREX EMPLOYEE VIA EMAIL THAT AN AR-5207 TENSIONLOC COLLAR BROKE. THIS OCCURRED DURING AN ACL RECONSTRUCTION. THE CASE WAS COMPLETED USING A NEW PRODUCT. THERE WAS NO PATIENT EFFECT REPORTED. ADDITIONAL INFORMATION REQUESTED. ADDITIONAL INFORMATION PROVIDED 10/05/2021 THE DEVICE BROKE IN THE PATIENT, ALL FRAGMENTS WERE REMOVED. THE CASE WAS COMPLETED USING A NEW AR-5207.

  Patient problems: Foreign Body In Patient

  MAUDE report 12738629 ↗
• MalfunctionJun 14, 2021Break; Difficult to Remove

  IT WAS REPORTED THAT THE AR-5207 TENSIONLOC COLLAR, WAS USED IN ACL RECONSTRUCTION. WHEN THE COLLAR WAS FIXED TO THE BONE HOLE USING A SILICON HAMMER AND THE PLUG OF THE PRODUCT WAS INSERTED INTO THE COLLAR, THE COLLAR OF THE PLUG JOINT BROKE CAUSING THE PRODUCT TO BECOME UNUSABLE. THE SURGEON COULD NOT REMOVE THE PLUG, AND THE PLUG IS STILL LEFT IN THE PATIENT. THE SURGERY WAS COMPLETED USING A PRODUCT FROM ANOTHER MANUFACTURER.

  Patient problems: Foreign Body In Patient

  MAUDE report 11991234 ↗