Arthrex® AR-1370PRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00888867014695), received between Jan 5, 2026 and Sep 17, 2026 — classified as 4 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 16, 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.

• MalfunctionSep 17, 2026Break

  On 3rd September 2026, it was reported by an Arthrex's employee via an Email that 1 unit of AR-1370P, PEEK Interference Screw, Sheathed, 7 x 23 mm, was fractured.This was detected during an arthroscopic left knee joint exploration + synovectomy + harvest of peroneus longus tendon, ACL revision and reconstruction on 13th August 2026. The procedure was completed successfully by using a new AR-1370P for the fixation. There were no patient harm and no secondary surgery needed

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50802265 ↗
• MalfunctionApr 10, 2026Break

  ON 23RD MARCH 2026, IT WAS REPORTED BY AN ARTHREX'S EMPLOYEE VIA AN EMAIL THAT FOR 1 UNIT OF AR-1370P, PEEK INTERFERENCE SCREW, SHEATHED, 7 X 23 MM, ITS ANCHOR BROKE DURING INSERTION. THIS WAS DETECTED DURING AN ARTHROSCOPIC ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION ON (B)(6) 2025. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY USING ANOTHER NEW AR-1370P. THERE WERE NO PATIENT HARM AND NO SECONDARY PROCEDURE NEEDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24839661 ↗
• MalfunctionMar 30, 2026Break

  ON 10TH MARCH 2026, IT WAS REPORTED BY AN ARTHREX'S EMPLOYEE VIA AN EMAIL THAT FOR 1 UNIT OF AR-1370P, PEEK INTERFERENCE SCREW, SHEATHED, 7 X 23 MM, ITS ANCHOR BROKE DURING INSERTION. THIS WAS DETECTED DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION SURGERY ON (B)(6) 2026. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY USING ANOTHER NEW AR-1370P. THERE WERE NO PATIENT HARM AND NO SECONDARY PROCEDURE NEEDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24716544 ↗
• MalfunctionJan 5, 2026Crack

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC SURGERY A LONGITUDINAL CRACK ALONG THE SCREW HAS FORMED DURING INSERTION. ALL PARTS WERE RETRIEVED FROM THE PATIENT. 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 23956622 ↗