Arthrex® AR-1360PRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00888867014039), received between May 22, 2023 and Mar 19, 2026 — classified as 7 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 16, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 19, 2026Break

  ON 27TH FEB 2026, IT WAS REPORTED BY AN ARTHREX'S EMPLOYEE VIA AN EMAIL THAT FOR 1 UNIT OF AR-1360P, PEEK INTERFERENCE SCREW, SHEATHED, 6 X 23 MM, ITS ANCHOR BROKE DURING INSERTION. THIS WAS DETECTED DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION SURGERY ON (B)(6) 2025. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY USING ANOTHER NEW AR-1360P. THERE WERE NO PATIENT HARM AND NO SECONDARY PROCEDURE NEEDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24637441 ↗
• MalfunctionSep 19, 2025Break; Break

  ON 2ND SEP 2025, IT WAS REPORTED BY AN ARTHREX'S EMPLOYEE VIA AN EMAIL THAT FOR (B)(4) UNIT OF AR-1360P, PEEK INTERFERENCE SCREW, SHEATHED, 6 X 23 MM, THE ANCHOR BROKE DURING INSERTION. THIS WAS DETECTED DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION SURGERY ON (B)(6) 2025. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY USING ANOTHER NEW AR-1360P. THERE WERE NO PATIENT HARM AND NO SECONDARY PROCEDURE NEEDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23095527 ↗
• MalfunctionDec 30, 2024Break; Break

  ON (B)(6) 2024 , IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT AN AR-1360P, PEEK INTERFERENCE SCREW, SHEATHED, 6 X 23 MM BROKE DURING INSERTION. THIS WAS DETECTED DURING A PATELLAR LIGAMENT RECONSTRUCTION SURGERY ON (B)(6) 2024 . ANCHOR WAS INSERTED EASILY BUT IT WAS FOUND BROKEN AT THE END. ALL FRAGMENTS WERE RETRIEVED FROM PATIENT. PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO PATIENT HARM AND NO SECONDARY PROCEDURE NEEDED BY USING ANOTHER NEW AR-1360P.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21036741 ↗
• MalfunctionDec 2, 2024Break; Break

  ON (B)(6) 2024, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT 2 UNITS OF AR-1360P,PEEK INTERFERENCE SCREW, SHEATHED, 6 X 23 MM BROKE DURING INSERTION. WHEN THE FIRST AR-1360P BROKE DURING INSERTION, THE SECOND AR-1360P WAS USED. HOWEVER, THE SAME SITUATION HAPPENED. THE BROKEN FRAGMENTS WERE RETRIEVED, AND THE CASE WAS COMPLETED USING ANOTHER NEW AR-1360P PEEK INTERFERENCE SCREW. THIS WAS DISCOVERED DURING A CRUCIATE LIGAMENT INJURY OF KNEE JOINT SURGERY ON (B)(6) 2024. THERE WAS NO PATIENT HARM AND NO SECONDARY PROCEDURE NEEDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20818511 ↗
• MalfunctionSep 26, 2024Break; Break

  ON 20TH SEPTEMBER 2024, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT 2 UNITS OF AR-1360P,PEEK INTERFERENCE SCREW, SHEATHED, 6 X 23 MM BROKE DURING INSERTION. WHEN THE FIRST AR-1360P BROKE DURING INSERTION, THE SECOND AR-1360P WAS USED. HOWEVER, THE SAME SITUATION HAPPENED. THE BROKEN FRAGMENTS WERE RETRIEVED, AND THE CASE WAS COMPLETED USING ANOTHER NEW AR-1360P PEEK INTERFERENCE SCREW. THIS WAS DISCOVERED DURING A CRUCIATE LIGAMENT INJURY OF KNEE JOINT SURGERY ON (B)(6) 2024. THERE WAS NO PATIENT HARM AND NO SECONDARY PROCEDURE NEEDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20311029 ↗
• MalfunctionMay 26, 2023Break; Break

  ON 5/5/2023, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT AN AR-1360P PEEK INTERFERENCE SCREW BROKE DURING INSERTION. THE BROKEN FRAGMENTS WERE RETRIEVED, AND THE CASE WAS COMPLETED USING ANOTHER AR-1360P PEEK INTERFERENCE SCREW. THIS WAS DISCOVERED DURING A RECONSTRUCTION OF THE PATELLAR LIGAMENT PROCEDURE ON(B)(6) 2023.

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

  MAUDE report 17010583 ↗
• MalfunctionMay 22, 2023Break; Break

  IT WAS REPORTED THAT DURING A MPFL KNEE RECONSTRUCTION WHILE THE SURGEON WAS SCREWING IN THE IMPLANT NUMEROUS RADIAL CRACKS APPEARED, WHICH MADE IT IMPOSSIBLE TO SCREW IT IN FULLY. EVERYTHING WAS RETRIEVED OUT OF THE PATIENT. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16973100 ↗