Arthrex® AR-1380TCRecalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00888867015357), received between Oct 18, 2016 and Apr 8, 2026 — classified as 2 injuries, 14 malfunctions.

The most frequently reported specific device problem is “Break” (12 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 16 most recent of 16 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 24818386 ↗
• MalfunctionDec 17, 2025Use of Device Problem; Damaged Thread; Use of Device Problem; Damaged Thread

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT SURGERY WITH A TIGHTROPE AND A SCREW THE THREAD OF THE SCREW GOT DAMAGED WHEN IT WAS INSERTED. 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 23829643 ↗
• MalfunctionDec 8, 2025Break; Break

  IT WAS REPORTED THAT DURING THE CRUCIATE LIGAMENT SURGERY THE DISTAL END OF THE SCREW BROKE OFF. THE BROKEN PIECES 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 23744070 ↗
• MalfunctionMay 9, 2024Break; Break

  ON (B)(6) 2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-4030C-08 FASTTHREAD BIOCOMPOSITE INTERFERENCE SCREW BROKE DURING INSERTION. THE BROKEN FRAGMENTS WERE COMPLETELY REMOVED. AN AR-1380TC FULL THREAD CANNULATED BIOCOMPOSITE INTERFERENCE SCREW WAS THEN INSERTER, AND IT ALSO BROKE AT THE TOP. THE SURGEON, HOWEVER, WAS ABLE TO IMPLANT IT SUCCESSFULLY. THIS WAS DISCOVERED DURING AN ACLR PROCEDURE ON (B)(6) 2024. THE PROCEDURE WAS DELAYED FIFTEEN MINUTES. THE PATIENT SUFFERED NO NEGATIVE EFFECTS.

  Patient problems: Foreign Body In Patient

  MAUDE report 19280602 ↗
• MalfunctionMay 6, 2024Break; Break

  ON 10/20/2022, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT AN AR-1380TC FULL THREAD CANNULATED BIOCOMPOSITE INTERFERENCE SCREW BROKE. ANOTHER NEW PRODUCT WAS USED, AND CASE WAS COMPLETED. ADDITIONAL INFORMATION RECEIVED ON 10/24/2022: THIS WAS DISCOVERED UPON OPENING PACKAGE PRIOR TO A PROCEDURE, THE SCREW WAS FOUND BROKEN. ANOTHER AR-1380TC FULL THREAD CANNULATED BIOCOMPOSITE INTERFERENCE SCREW, FROM THE SAME LOT NUMBER WAS USED TO COMPLETE THE CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19254671 ↗
• MalfunctionNov 1, 2023Break; Break

  ON (B)(6) 2023, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA EMAIL THAT AN AR-1380TC FULL THREAD CANNULATED BIOCOMPOSITE INTERFERENCE SCREW BROKE WHEN IT WAS INSERTED HALF WAY. THE BROKEN FRAGMENTS WERE RETRIEVED AND ANOTHER AR-1380TC FULL THREAD CANNULATED BIOCOMPOSITE INTERFERENCE SCREW WAS USED TO COMPLETE THE CASE. THIS WAS DISCOVERED DURING AN ACLR ON (B)(6) 2023.

  Patient problems: Insufficient Information

  MAUDE report 18046039 ↗
• MalfunctionOct 13, 2023Positioning Failure; Loosening of Implant Not Related to Bone-Ingrowth; Positioning Failure; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT SURGERY THE SCREW COULD NOT BE TIGHTENED / HAD BECOME LOOSE. NO PART OF THE DEVICE BROKE OFF. ACCORDING TO THE SURGEON NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY OCCURRED. 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; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17929138 ↗
• MalfunctionJun 7, 2023Break; Break

  IT WAS REPORTED THAT DURING A CRUCIATE LIGAMENT PLASTIC THE THREAD OF THE IMPLANT BROKE OFF. 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. (B)(6) 2023 UPDATE DW FURTHER INFORMATION WERE PROVIDED THAT THE BROKEN PIECES WERE RETRIEVED OUT OF THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17078259 ↗
• MalfunctionAug 15, 2022Break

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT (ACL) SURGERY WHILE SCREWING IN THE IMPLANT THE BOLT OF THE DEVICE BROKE OFF INSIDE THE PATIENT. THE BROKEN PIECES WERE RETRIEVED FROM PATIENT. 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 15224109 ↗
• MalfunctionJun 13, 2022Break

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT SURGERY THE SCREW BROKE OFF AT THE TIP DURING INSERTION. IT WAS COMPLETELY REMOVED FROM PATIENT. 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 14676852 ↗
• MalfunctionMay 31, 2022Break; Material Deformation

  ON (B)(6) 2022, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT (2) AR-1380TC FULL THREAD CANNULATED BIO-COMPOSITE INTERFERENCE SCREW AND AN AR-1390TC FULL THREAD CANNULATED BIOCOMPOSITE INTERFERENCE SCREW BROKE DURING TENSIONING. SURGEON STATED THE SCREWS SHOWED SOME TYPE OF DEFORMATION, WHICH HAS BEEN SEEN BEFORE IN OTHER SURGERY BUT THE SCREWS HAVE NEVER BROKEN BEFORE. SURGEON USED A FOURTH SCREW FROM A DIFFERENT LOT NUMBER THAN THE PERVIOUS ONES AND COMPETED THE CASE WITHOUT FURTHER ISSUES. THIS WAS DISCOVERED DURING AN ACL RECONSTRUCTION UNDER ARTHROSCOPY PROCEDURE ON (B)(6) 2022.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14547199 ↗
• MalfunctionMay 31, 2022Break; Material Deformation

  ON 5/10/2022, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT (2) AR-1380TC FULL THREAD CANNULATED BIO-COMPOSITE INTERFERENCE SCREW AND AN AR-1390TC FULL THREAD CANNULATED BIOCOMPOSITE INTERFERENCE SCREW BROKE DURING TENSIONING. SURGEON STATED THE SCREWS SHOWED SOME TYPE OF DEFORMATION, WHICH HAS BEEN SEEN BEFORE IN OTHER SURGERY BUT THE SCREWS HAVE NEVER BROKEN BEFORE. SURGEON USED A FOURTH SCREW FROM A DIFFERENT LOT NUMBER THAN THE PERVIOUS ONES AND COMPETED THE CASE WITHOUT FURTHER ISSUES. THIS WAS DISCOVERED DURING AN ACL RECONSTRUCTION UNDER ARTHROSCOPY PROCEDURE ON (B)(6) 2022.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14547195 ↗
• MalfunctionNov 16, 2021Material Fragmentation

  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: Foreign Body In Patient

  MAUDE report 12819532 ↗
• MalfunctionSep 7, 2021Break

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION SURGERY WITH PATELLAR TENDON THE DEVICE BROKE DURING IMPLANTATION. NO BROKEN PARTS REMAINED INSIDE THE PATIENT. ACCORDING TO THE SURGEON NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY OCCURRED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A DIFFERENT DEVICE. A BUTTON WAS USED INSTEAD OF THE SCREW FOR TIBIAL FIXATION. IT WAS NOT NECESSARY TO DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12434028 ↗
• InjuryFeb 8, 2019Break

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT SURGERY WHEN SCREWING INTO THE TIBIAL TUNNEL, THE SCREW BROKE ON THE SCREWDRIVER, AT THE MIDDLE OF THE THREAD. SAME PROBLEM OCCURRED WITH THE SECOND IMPLANT. THE BROKEN PIECES REMAIN IN THE PATIENT. THE SURGERY WAS FINISHED SUCCESSFULLY WITH THE SAME DEVICE WHICH WAS USED ANYWAY. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY. UPDATE 01-FEB-2019: NOTHING BROKE OFF THE SCREWDRIVER. ONLY THE SCREW BROKE WHILE IT WAS CORRECTLY MOUNTED ON THE SCREWDRIVER. THE SURGEON TRIED TO PUT A SECOND SCREW NEXT TO THE FEMORAL SCREW IN PLACE WITHOUT SUCCESS, IT BROKE TOO. BUT HE DID NOT WANT TO AGGRAVATE THE STRUCTURE THAT COULD BE FRAGILE, HE GAVE UP. THE BROKEN SCREWS SEEM WELL FIXED IN THE BONE. BUT ACCORDING TO SURGEON THERE IS A POSSIBILITY THAT THE FIXATION WILL BREAK, IF IT´S NOT ENOUGH, BUT HE COULD NOT KNOW.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8322020 ↗
• InjuryOct 18, 2016Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEW WEEKS AFTER A (B)(6) 2015 ACL PROCEDURE THE PATIENT CLAIMED ABOUT THE APPEARANCE OF A BULGE CLOSE TO THE KNEE (SUBCUTANEUS). THE SCREW WAS REMOVED IN THE MIDDLE OF SEPTEMBER 2016 (SPECIFIC REVISION DATE NOT PROVIDED. (B)(6) 2016 WILL BE USED AS THE EVENT DATE). LIGAMENT FIXATION IS STABLE. PATIENT MALE, (B)(6).

  Patient problems: No Code Available

  MAUDE report 6037754 ↗