Arthrex® AR-1370TCRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00888867014725), received between Oct 10, 2017 and Apr 8, 2026 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Break” (5 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 8, 2026Break

  IT WAS REPORTED THAT DURING THE ANTERIOR CRUCIATE LIGAMENT SURGERY, THE SCREWS BROKE AT THE LEVEL OF THE SCREW HEAD. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH THE SAME DEVICE WAS USED ANYWAY. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24818430 ↗
• MalfunctionJun 4, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ACL SURGERY THE TIGHTROPE BROKE OFF FEMORALLY. THE SCREW BROKE OFF FEMORALLY DURING INSERTION AND DID NOT HOLD. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22142747 ↗
• MalfunctionJun 10, 2024Break; Break

  IT WAS REPORTED THAT, DURING AN ANTERIOR CRUCIATE LIGAMENT SURGERY, THE SCREW BROKE OFF WHEN IT WAS IMPLANTED. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY. UPDATE (B)(6) 21-MAY-2024: FURTHER INFORMATION WAS PROVIDED THAT ALL BROKEN PIECES WERE RETRIEVED OUT OF THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19498638 ↗
• MalfunctionSep 29, 2023Defective Device; Material Twisted/Bent; Defective Device; Material Twisted/Bent

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT SURGERY THE THREAD ON THE SCREW HAS TWISTED OFF. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE (AR-1380TC). IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: Failure of Implant; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17843038 ↗
• MalfunctionJun 7, 2023Break; Break

  IT WAS REPORTED THAT DURING A CRUCIATE LIGAMENT PLASTIC THE THREAD OF THE IMPLANT BROKE OFF WHEN IT WAS INSERTED. HERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY. 11-MAY-2023 UPDATE DW FURTHER INFORMATION WERE PROVIDED THAT THE BROKEN PIECES WERE RETRIEVED OUT OF THE PATIENT.

  Patient problems: Failure of Implant; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17077783 ↗
• InjuryOct 10, 2017Break

  IT WAS REPORTED THAT THERE WAS A THREAD FAILURE PREVENTING COMPRESSION IN THE BONE TUNNEL. THE HEAD OF THE SCREW BROKE INSIDE THE PATIENT BUT THE SURGEON WAS ABLE TO REMOVE THIS BROKEN FRAGMENT. THE REST OF THE PARTIAL SCREW IS IMPLANTED IN THE TIBIA. FOLLOW UP INVESTIGATION 26 SEPTEMBER 2017: THE SURGEON CONFIRMED THAT THE TENDON IS SECURELY FIXED IN TUNNEL ONLY THE SCREWDRIVER'S FOOTPRINT BROKE, ABOUT 3 MM, AND WAS REMOVED. THE REMAINING 20 MM OF THE SCREW WAS LEFT IN THE TIBIAL TUNNEL AS A PARTIAL IMPLANT AND WAS REPORTED TO HAVE A GOOD HOLD.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6934408 ↗