Arthrex® AR-5210Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00888867265820), received between May 31, 2023 and Mar 2, 2026 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 2, 2026Break

  ON 10-FEB-2026, AN ARTHREX SUBSIDIARY EMPLOYEE REPORTED VIA EMAIL THAT AN AR-5210 TENSIONLOC COLLAR AND PLUG IMPLANT (10 MM) EXPERIENCED AN ISSUE DURING A PROCEDURE PERFORMED ON (B)(6) 2026. A PORTION OF THE COLLAR BROKE WHILE IT WAS BEING HAMMERED IN. THE BROKEN PIECE WAS REMOVED USING AN ELEVATOR, AND A REPLACEMENT AR-5210 IMPLANT WAS SUCCESSFULLY INSERTED. THE PROCEDURE WAS COMPLETED WITHOUT SIGNIFICANT DELAY. NO ADDITIONAL ANESTHESIA WAS REQUIRED, AND NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24482219 ↗
• MalfunctionAug 25, 2025Break; Break

  ON 08/05/2025, AN ARTHREX SUBSIDIARY EMPLOYEE REPORTED VIA EMAIL THAT AN AR-5210 TENSIONLOC COLLAR AND PLUG IMPLANT HAD AN ISSUE WHEN THE COLLAR WAS INSERTED; IT SANK INTO THE BONE, CAUSING DAMAGE AROUND THE COLLAR. ALL BROKEN PIECES WERE REMOVED FROM THE PATIENT. THE CASE WAS COMPLETED USING A REPLACEMENT AR-5210 TENSIONLOC COLLAR AND PLUG IMPLANT. THIS ISSUE WAS DISCOVERED DURING AN ACL RECONSTRUCTION PROCEDURE ON (B)(6) 2025, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION WAS RECEIVED ON 08/13/2025: THERE WAS NO SIGNIFICANT CASE DELAY, AND NO ADDITIONAL ANESTHESIA WAS ADMINISTERED. NO ADVERSE EFFECTS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED ON 08/21/2025: IT WAS FURTHER CLARIFIED THAT THE DAMAGE WAS LIMITED TO THE DEVICE AND THAT THE PATIENT'S BONE TISSUE REMAINED UNAFFECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22888663 ↗
• MalfunctionMay 12, 2025Positioning Failure; Positioning Failure

  ON 04/14/2025, AN ARTHREX SUBSIDIARY EMPLOYEE REPORTED VIA EMAIL THAT AN AR-5210 TENSIONLOC¿ COLLAR AND PLUG IMPLANT HAD A FIXATION FORCE THAT WAS WEAK AND AS A RESULT COULD NOT BE USED. THE CASE WAS COMPLETED BY USING ANOTHER DEVICE FROM A DIFFERENT COMPANY. THIS WAS DISCOVERED DURING A CASE (B)(6) 2025, WITH NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22001834 ↗
• MalfunctionSep 8, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON 08/14/2023, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT AN AR-5210 TENSIONLOC COLLAR AND PLUG COULD NOT BE SECURED AFTER IMPLANTATION. THIS WAS DISCOVERED DURING A TIBAL FIXATOR FOR ACLR PROCEDURE ON (B)(6) 2023. A NEW PRODUCT WAS USED TO COMPLETE THE CASE. ADDITIONAL INFORMATION RECEIVED ON 8/23/2023: AFTER THE GRAFT WAS IMPLANTED AND PASSED THROUGH THE TENSIONLOC COLLAR, THERE WAS A LOSS IN FIXATION, AND THE PLUG COULD NOT BE SECURED.

  Patient problems: Failure of Implant

  MAUDE report 17710215 ↗
• MalfunctionMay 31, 2023Break; Break

  ON (B)(4) 2023, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT AN AR-5210 COLLAR AND PLUG IMPLANT BROKE. THIS OCCURRED DURING A CASE ON (B)(6) 2023, DURING INSERTION A PORTION OF THE COLLAR WAS BROKEN. ALL FRAGMENTS OF THE BROKEN DEVICE WERE RETRIEVED. THE CASE WAS COMPLETED USING ANOTHER AR-5210.

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

  MAUDE report 17030504 ↗