Arthrex® AR-1390CRecalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00888867015517), received between Jul 28, 2016 and Sep 18, 2025 — classified as 6 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 18, 2025Break; Break

  ON 08/27/2025, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA SEMS-07048401 THAT AN AR-1390C BIO-COMP INTERFSCRW W/DISP SHTH SCREW BROKE DURING SURGERY. THIS WAS DISCOVERED DURING THE CASE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23083717 ↗
• MalfunctionJun 7, 2024Damaged Thread; Damaged Thread

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT SURGERY THE IMPLANT BROKE OFF AS IT WAS SCREWED IN. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH A DIFFERENT PART NUMBER (AR-1380TC). IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY. 28-OCT-2021 UPDATE FURTHER INFORMATION WERE PROVIDED THAT THE INITIAL PROVIDED DESCRIPTION WAS INCORRECT. THE SCREW WAS FLATTENED AND THEREFORE LOST ITS EDGES AND REMAINED FLAT. THIS ISSUE PREVENTING IT FROM CATCHING THE THREAD IN THE BONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19487925 ↗
• MalfunctionDec 15, 2023Failure to Capture; Failure to Capture

  ON 11/21/2023, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA (B)(4) THAT AN AR-1390C BIOCOMPOSITE INTERFERENCE SCREW LOST THE THREAD. THIS OCCURRED DURING A CASE WHERE ANOTHER DEVICE WAS USED TO COMPLETE THE CASE.

  Patient problems: Insufficient Information

  MAUDE report 18340832 ↗
• MalfunctionJun 6, 2022Break

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION SURGERY THE DEVICE TWISTED AND BROKE IN HALF OF ITS LENGTH WHEN SCREWED IN. ALL BROKEN PARTS COULD BE RETRIEVED FROM THE PATIENT. ACCORDING TO THE SURGEON NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY OCCURRED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A DIFFERENT DEVICE BY SWITCHING THE SURGICAL TECHNIQUE. IT WAS NOT NECESSARY TO DO A SECOND SURGERY. NO FURTHER INFORMATION WAS RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14603568 ↗
• InjuryApr 25, 2022Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2022, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT ON (B)(6) 2022, PATIENT HAD AN ACL PROCEDURE DONE USING AN AUTOGRAFT, WHICH WAS FIXED WITH A TIGHTROPE SYSTEM IN THE FEMUR AND A BIO-COMPOSITE SCREW IN THE TIBIA. ON (B)(6) 2022, SURGEON PERFORMED A REVISION SURGERY ON PATIENT TO REMOVE ALL IMPLANTS DUE TO AN INFECTION. ADDITIONAL INFORMATION RECEIVED ON 4/12/2022: THE PART AND LOT NUMBER FOR THE AUTOGRAFT USED IN THE ORIGINAL PROCEDURE REMAINS UNKNOWN. THIS INFECTION WAS DISCOVERED FIVE DAY AFTER PROCEDURE ON (B)(6) 2022 AND AN AR-1588RT ACL TIGHTROPE, LOT 13822428, AND AN AR-1390C BIO-COMPOSITE INTERFERENCE SCREW, LOT 10964516, WERE REMOVED FROM THE PATIENT DURING THE REVISION SURGERY ON (B)(6) 2022. SURGEON HAD THE INFECTED AREAS BIOPSIED AND THE RESULTS CAME BACK AS A (B)(6) CULTURE TO (B)(6). THE EXPLANTED DEVICES HAVE BEEN SENT TO THE LAB FOR FURTHER TESTING. CURRENTLY, THE PATIENT IS BEING TREATED WITH ANTIBIOTICS.

  Patient problems: Unspecified Infection

  MAUDE report 14192882 ↗
• MalfunctionNov 16, 2021Break

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT SURGERY MULTIPLE SCREWS BROKE OR CRUMBLED. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. NO FURTHER INFORMATION RECEIVED. 13-NOV-2021 UPDATE: FURTHER INFORMATION WERE PROVIDED THAT THE HE 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. THE SURGEON WAS ABLE TO RETRIEVE THE BROKEN FRAGMENTS OUT OF THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12819522 ↗
• MalfunctionJun 1, 2021Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY THE SCREW BROKE OFF INSIDE THE PATIENT. THE BROKEN FRAGMENT WAS RETRIEVED. NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY WAS 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: Failure of Implant

  MAUDE report 11912238 ↗
• InjuryNov 4, 2020Patient-Device Incompatibility

  IT WAS REPORTED THAT THE SCREW WAS IMPLANTED ON (B)(6) 2017 DURING AN ACL PROCEDURE INTO THE TIBIA. THE PATIENT DEVELOPED AN INFLAMMATION REACTION IN THE TIBIA AFTER THE ACL PROCEDURE. THE SCREW REMAINS IN THE PATIENT. NO MORE INFORMATION HAS BEEN MADE AVAILABLE.

  Patient problems: Inflammation; Reaction

  MAUDE report 10784457 ↗
• InjuryNov 4, 2020Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT TWO SCREWS WERE IMPLANTED ON (B)(6) 2015 DURING AN ACL PROCEDURE. THE PATIENT DEVELOPED AN INFLAMMATION REACTION IN THE TIBIA AFTER THE ACL PROCEDURE. ONLY THE TIBIAL SCREW LEAD TO A REACTION. AS THE TIBIAL AND FEMORAL SCREW HAVE THE SAME DIMENSION THE SURGEON IS UNABLE TO TELL WHICH BATCH CREATED THE REACTION. THE SCREW REMAINS IN THE PATIENT. NO MORE INFORMATION HAS BEEN MADE AVAILABLE.

  Patient problems: Inflammation; Reaction

  MAUDE report 10784428 ↗
• InjuryNov 4, 2020Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT TWO SCREWS WERE IMPLANTED ON (B)(6) 2015 DURING AN ACL PROCEDURE. THE PATIENT DEVELOPED AN INFLAMMATION REACTION IN THE TIBIA AFTER THE ACL PROCEDURE. ONLY THE TIBIAL SCREW LEAD TO A REACTION. AS THE TIBIAL AND FEMORAL SCREW HAVE THE SAME DIMENSION THE SURGEON IS UNABLE TO TELL WHICH BATCH CREATED THE REACTION. THE SCREW REMAINS IN THE PATIENT. NO MORE INFORMATION HAS BEEN MADE AVAILABLE.

  Patient problems: Inflammation

  MAUDE report 10784414 ↗
• InjuryNov 4, 2020Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SCREW WAS IMPLANTED ON (B)(6) 2015 DURING AN ACL PROCEDURE INTO THE TIBIA. THE PATIENT DEVELOPED AN INFLAMMATION REACTION IN THE TIBIA AFTER THE ACL PROCEDURE. THE SCREW REMAINS IN THE PATIENT. NO MORE INFORMATION HAS BEEN MADE AVAILABLE.

  Patient problems: Inflammation

  MAUDE report 10784237 ↗
• InjuryJul 28, 2016Insufficient Device Problem Information

  IT WAS REPORTED THAT THERE WAS A FAILURE OF 5 DEGREE EXTENSION AND PAIN. THE KNEE IS STABLE. DURING THE SECOND SURGERY, A CULTURE SAMPLE WAS SENT FOR ANALYSIS. WITHOUT THE LABORATORY RESULTS, A CLINICAL RESULT WAS DIAGNOSED BY SURGEON; INDICATING THERE WERE NO SIGNS OF INFECTION. PATIENT HAS NO KNOWN ALLERGIES, IS A NON-SMOKER, IS NOT LACTOSE INTOLERANT AND HAS THROMBOCYTOPENIC PURPURA WITH PERMANENT TREATMENT. NO MEDICAL TREATMENT WAS GIVEN BECAUSE THERE WERE NO RESULTS FROM PREVIOUS CASES. ON (B)(6) 2016, A SECOND ARTHROSCOPIC SURGERY TOOK PLACE WITH NEO-LIGAMENT. INDEMNITY WITH FIBROSIS GRAFT (CYCLOPS) TO DRY, AND A MINIMAL NOTCH OF PLASTIA. IT WAS INCISED ON PREVIOUS SCAR LOCATED IN THE TIBIAL TUNNEL WITH REMAINS OF WHITE CLUMPY WHITE SCREW. THERE WAS NO TYPE OF BIO-INTEGRATION, CURETTED THE AREA, AND THE MATERIAL SAMPLE WAS SENT TO PATHOLOGY (THERE WERE NO SIGNS OF CLINICAL INFECTION) THE TUNNEL WAS CLEANED AND NOT TO BE FILLED. THE REMAINS OF THE IMPLANT WAS RETRIEVED FROM PATIENT. THE ORIGINAL SURGERY TOOK PLACE ON (B)(6) 2014.

  Patient problems: Pain

  MAUDE report 5828805 ↗