Arthrex® AR-1380CRecalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00888867015272), received between Dec 21, 2017 and Jan 21, 2026 — classified as 8 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Break” (6 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.

• MalfunctionJan 21, 2026Crack

  ON 6 JANUARY 2026, A DISTRIBUTOR REPORTED VIA EMAIL THAT AR-1380C LOT 15322180 BIO-COMP INTERFSCRW W/DISP SHTH'S BIO-SCREW CRACK DURING ACL PROCEDURES ON 05TH NOV 2025. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH AN ADDITIONAL AR-1380C, AND NO PATIENT HARM WAS REPORTED ON PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24129818 ↗
• MalfunctionFeb 7, 2025Positioning Failure; Fitting Problem; Positioning Failure; Fitting Problem

  IT WAS REPORTED THAT DURING A KNEE SURGERY THE SCREW DID NOT GRIP. 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 21333452 ↗
• MalfunctionNov 3, 2023Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT PLASTIC THE SCREW HAS TWISTED OFF DURING INSERTION. 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18067672 ↗
• MalfunctionJun 26, 2023Break; Break

  ON 6/5/2023, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT AN AR-1380C BIOCOMPOSITE INTERFERENCE SCREW BROKE DURING INSERTION. THIS WAS DISCOVERED DURING A RIGHT KNEE LIGAMENT RECONSTRUCTION PROCEDURE ON (B)(6) 2022. ALL THE BROKEN FRAGMENTS WERE RETRIEVED, AND THE CASE WAS COMPLETED SUCCESSFULLY USING ANOTHER AR-1380C BIOCOMPOSITE INTERFERENCE SCREW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17202848 ↗
• MalfunctionJun 9, 2023Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC SURGERY THE TIP OF THREE DIFFERENT IMPLANTS BROKE OFF. THE BROKEN PIECES WERE 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 AN AR-5028C-09. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY. *** 17-MAY-2023 UPDATE DW: FURTHER INFORMATION WERE PROVIDED THAT THE SURGEON USED ALL THE REPORTED IMPLANTS DURING ONE SURGERY AND THEREFORE EXTENDED THE DRILL HOLE TO 9MM. IT WAS FURTHER REPORTED THAT A PART OF THE LAST IMPLANT WHICH WAS USED TO FINISH THE SURGERY BROKE OFF AS WELL. HOWEVER THE SURGEON WAS SATISFIED WITH THE FIXATION AND THEREFORE FINISHED THE SURGERY WITH THE DAMAGED IMPLANT.

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

  MAUDE report 17098339 ↗
• InjuryJan 4, 2022Appropriate Device Problem Term/Code Not Available

  ON (B)(6) 2021, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-1380C BIO-COMPOSITE INTERFERENCE SCREW AND AR-4030C-09 FAST-THREAD BIO-COMPOSITE INTERFERENCE SCREW WERE EXPLANTED DUE TO A POST-OPERATIVE INFECTION. THE REVISION TOOK PLACE DUE TO AN INFECTION BUT THE ROOT CAUSE OF THE INFECTION IS UNKNOWN. NO ADDITIONAL INFORMATION PROVIDED. ADDITIONAL INFORMATION REQUESTED.

  Patient problems: Unspecified Infection

  MAUDE report 13153299 ↗
• MalfunctionNov 16, 2021Break; Device Fell

  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 12819530 ↗
• MalfunctionNov 16, 2021Break; Device Fell

  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 12819501 ↗
• MalfunctionNov 16, 2021Break

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT SURGERY THE DEVICE WASN'T IN A GOOD CONDITIONS AND BROKE WHEN IT WAS IMPLANTED. 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 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 12819461 ↗
• InjuryDec 14, 2020Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT DEVELOPED A TIBIAL CYST AFTER AN ANTERIOR CRUCIATE LIGAMENT REPAIR. NO FURTHER INFORMATION RECEIVED. THE SURGEON WAS NOT ABLE TO PROVIDE THE SPECIFIC LOT NUMBER OF THE REPORTED DEVICE. IT IS EITHER 10254192 OR 10255018. UPDATE 01-DEC-2020: FURTHER INFORMATION WERE PROVIDED THAT THE INITIAL SURGERY WAS PERFORMED ON (B)(6) 2020 AND THE ISSUE WAS IDENTIFIED ON (B)(6) 2020. IT WAS FURTHER REPORTED THAT A REVISION WAS PERFORMED TO SOLVE THE REPORTED ISSUE.

  Patient problems: Cyst(s)

  MAUDE report 11003997 ↗
• InjuryDec 14, 2020Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT DEVELOPED A TIBIAL CYST AFTER AN ANTERIOR CRUCIATE LIGAMENT REPAIR. NO FURTHER INFORMATION RECEIVED. UPDATE 01-DEC-2020: FURTHER INFORMATION WERE PROVIDED THAT THE INITIAL SURGERY WAS PERFORMED ON (B)(6) 2019 AND THAT THE REPORTED PROBLEM WAS IDENTIFIED ON (B)(6) 2020. IT WAS FURTHER REPORTED THAT THE PATIENT WAS TREATED CONSERVATIVELY AND HAD PERSISTENT PAIN.

  Patient problems: Cyst(s)

  MAUDE report 11003970 ↗
• InjuryNov 4, 2020Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT TWO SCREWS WERE IMPLANTED ON (B)(6) 2019 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. FURTHER QUESTIONS WILL BE ASKED.

  Patient problems: Inflammation; Reaction

  MAUDE report 10784402 ↗
• InjuryNov 4, 2020Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT TWO SCREWS WERE IMPLANTED ON (B)(6) 2019 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 10784386 ↗
• InjuryMar 27, 2019Patient-Device Incompatibility; Patient Device Interaction Problem; Patient-Device Incompatibility; Patient Device Interaction Problem

  IT WAS REPORTED THAT APPROXIMATELY ONE MONTH AND A HALF AFTER HAVING A PRIMARY BTB ACL AUTOGRAFT PROCEDURE PERFORMED, THE PATIENT STARTED EXPERIENCING SWELLING OF THE HANDS, FEET, AND FACE WITH A REPORTED INCREASED LEVEL OF PAIN ON THE OPERATIVE KNEE. THE ORIGINAL PROCEDURE TOOK PLACE ON (B)(6) 2019. THE REP CONFIRMED THERE ARE NO SIGNS OF INFECTION, AND NO SIGNS OF INCREASED SWELLING AROUND THE OPERATIVE KNEE. THE REP STATED THERE IS NOT A REVISION PROCEDURE SCHEDULED AT THIS TIME. THE FOLLOWING ARTHREX PARTS WERE IMPLANTED DURING THE ORIGINAL PROCEDURE, AND REMAIN IMPLANTED IN THE PATIENT: AR-1380C // LOT: 1023538 // QTY.: 1. AR-1380C // LOT: 1024227 // QTY.: 1. AR-2324BCC // LOT: 1020860 // QTY.: 1. ADDITIONAL INFORMATION RECEIVED ON 3/14/2019: THE FACILITY CONFIRMED THAT THE PATIENT IS NOT BEING TREATED WITH ANY MEDICATIONS AT THIS TIME. THE PATIENT WAS ADVISED BY THEIR PRIMARY PHYSICIAN TO MONITOR SYMPTOMS. THE FACILITY IS SENDING TO HAVE ALLERGY TESTING DONE.

  Patient problems: Pain; Swelling

  MAUDE report 8456852 ↗
• InjuryMar 27, 2019Patient-Device Incompatibility; Patient Device Interaction Problem; Patient-Device Incompatibility; Patient Device Interaction Problem

  IT WAS REPORTED THAT APPROXIMATELY ONE MONTH AND A HALF AFTER HAVING A PRIMARY BTB ACL AUTOGRAFT PROCEDURE PERFORMED, THE PATIENT STARTED EXPERIENCING SWELLING OF THE HANDS, FEET, AND FACE WITH A REPORTED INCREASED LEVEL OF PAIN ON THE OPERATIVE KNEE. THE ORIGINAL PROCEDURE TOOK PLACE ON (B)(6) 2019. THE REP CONFIRMED THERE ARE NO SIGNS OF INFECTION, AND NO SIGNS OF INCREASED SWELLING AROUND THE OPERATIVE KNEE. THE REP STATED THERE IS NOT A REVISION PROCEDURE SCHEDULED AT THIS TIME. THE FOLLOWING ARTHREX PARTS WERE IMPLANTED DURING THE ORIGINAL PROCEDURE, AND REMAIN IMPLANTED IN THE PATIENT: AR-1380C, LOT: 1023538, QTY.: 1; AR-1380C, LOT: 1024227, QTY.: 1; AR-2324BCC, LOT: 1020860, QTY.: 1; ADDITIONAL INFORMATION RECEIVED ON 3/14/2019: THE FACILITY CONFIRMED THAT THE PATIENT IS NOT BEING TREATED WITH ANY MEDICATIONS AT THIS TIME. THE PATIENT WAS ADVISE BY THEIR PRIMARY PHYSICIAN TO MONITOR SYMPTOMS. THE FACILITY IS SENDING TO HAVE ALLERGY TESTING DONE.

  Patient problems: Pain; Swelling

  MAUDE report 8456788 ↗
• InjuryDec 21, 2017Break; Difficult to Remove

  IT WAS REPORTED THAT DURING AN ACL PROCEDURE THE SCREW BROKE WHILE INSERTING BETWEEN THE THREAD AND THE HEAD. PART OF THE SCREW WILL REMAIN INSIDE THE PATIENT FIXED INTO THE BONE. ACCORDING TO THE SURGEON, ENOUGH OF THE SCREW IS LEFT TO MAINTAIN THE LIGAMENT ON PLACE. NO NEW SCREW WAS USED AND A SECOND SURGERY WAS NOT NECESSARY.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 7137341 ↗