Arthrex® AR-1360CRecalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00888867014008), received between Nov 16, 2016 and Mar 31, 2026 — classified as 3 injuries, 13 malfunctions.

The most frequently reported specific device problem is “Break” (9 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.

• MalfunctionMar 31, 2026Break

  IT WAS REPORTED THAT DURING FLEXOR HALLUCIS LONGUS-TRANSFER SURGERY THE SURGEON PRE DRILLED HOLES WITH A 6MM DRILL BIT AND ATTEMPTED TO FIXATE THE TENDON WITH THE REPORTED SCREW. HOWEVER, THE REPORTED DEVICE BROKE OFF DURING THE IMPLANTATION. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY. UPDATE 12-MAR-2026: FURTHER INFORMATION WAS PROVIDED THAT THE FIRST SCREW WAS REMOVED AFTER IT BROKE OFF AND REPLACED WITH A NEW ONE WITH THE SAME PART NUMBER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24741839 ↗
• MalfunctionMar 31, 2026Break

  IT WAS REPORTED THAT DURING FLEXOR HALLUCIS LONGUS-TRANSFER SURGERY THE SURGEON PRE DRILLED HOLES WITH A 6MM DRILL BIT AND ATTEMPTED TO FIXATE THE TENDON WITH THE REPORTED SCREW. HOWEVER, THE REPORTED DEVICE BROKE OFF DURING THE IMPLANTATION. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY. UPDATE 12-MAR-2026: FURTHER INFORMATION WAS PROVIDED THAT THE FIRST SCREW WAS REMOVED AFTER IT BROKE OFF AND REPLACED WITH A NEW ONE WITH THE SAME PART NUMBER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24741772 ↗
• MalfunctionJun 5, 2025Use of Device Problem; Damaged Thread; Use of Device Problem; Damaged Thread

  IT WAS REPORTED THAT DURING A LARSON PLASTIC EXTERNAL LIGAMENT STABILIZATION KNEE SURGERY, THE SCREW AR-1360C COULD NOT BE INSERTED, BECAUSE THE THREAD WAS DEFECTIVE. A 6 MM BORE AND 6 MM HOLE WAS PREPARED NEVERTHELESS THE SCREW FAILED. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A DIFFERENT DEVICE. INSTEAD OF USING A SCREW, THE SURGEON ONLY SEWED. IT WAS NOT NECESSARY TO DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22150961 ↗
• MalfunctionNov 26, 2024Break; Break

  ON 4TH NOVEMBER 2024, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT AN AR-1360C, BIOCOMPOSITE INTERFERENCE SCREW, WITH DISPOSABLE SHEATH, 6 X 23MM, BROKE DURING INSERTION. THIS WAS DETECTED DURING USE IN A MEDIAL PATELLOFEMORAL LIGAMENT (MPFL) PROCEDURE ON (B)(6) 2024. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AS A REPLACEMENT SCREW WAS USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20781584 ↗
• MalfunctionJun 2, 2024Crack; Crack

  IT WAS REPORTED THAT DURING KNEE ANTERIOR CRUCIATE LIGAMENT SURGERY WHEN SCREWING IN THE SCREW, THE THREAD CRACKED. THE SURGEON HAD PRE-DRILLED. NOTHING BROKE OFF. 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 19444687 ↗
• MalfunctionMay 22, 2024Defective Device; Defective Device

  IT WAS REPORTED THAT DURING A KNEE ARTHROSCOPY SCREWING THE DEVICE INTO THE BONE WAS IMPOSSIBLE. 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. UPDATE SWIT 26-APR-2024: SCREWING INTO THE BONE WAS IMPOSSIBLE, BECAUSE THE THREAD WAS DAMAGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19378324 ↗
• MalfunctionMay 6, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A POSTERIOR CRUCIATE LIGAMENT SURGERY THE BONE STRUCTURE HAS GIVEN WAY DURING THE IMPLANTATION OF THE DEVICE AND NO SECURE FIXATION OF THE DEVICE WAS POSSIBLE. THE BONE TUNNEL WAS INITIALLY PREPARED FOR A 6X23 MM SCREW, BUT A 8X28 MM SCREW WAS FINALLY USED FOR A SECURE FIXATION. THERE WAS NO HARM OR ADVERSE EVENT FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A DIFFERENT DEVICE (AR-5028C-08). IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY. UPDATE AVOE 28-JUN-2021: IT WAS CONFIRMED THAT NO NEW BONETUNNEL HAD TO BE DRILLED. THE ANCHOR IS USUALLY IMPLANTED BY HAMMERING THE METAL BUTTON ON THE BOTTOM UNTIL IT IS FLUSH WITH THE HANDPIECE. IT WAS FURTHER CONFIRMED THAT THE METAL BUTTON OF THE DEVICE BROKE OFF. THE EXACT MOMENT WHEN THE METAL BUTTON BROKE IS UNCLEAR. ONLY THE FRONT PART OF THE ENTIRE DEVICE IS INSIDE THE PATIENT'S JOINT, WHICH MEANS THAT THE BREAKAGE POINT MUST HAVE BEEN OUTSIDE OF THE PATIENT. NOTHING HAD TO BE RETRIEVED FROM THE PATIENT. BECAUSE THE METAL BUTTON HAD BROKEN OFF AT THE BOTTOM, THE SURGEON HAD TO HIT THE HANDPIECE TO ADVANCE THE ANCHOR FURTHER. AFTER THE SU

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19255738 ↗
• MalfunctionMay 3, 2024Difficult to Advance; Difficult to Advance

  ON 10/20/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT (2) AR-1360C BIOCOMPOSITE INTERFERENCE SCREW HAD AN ISSUE WITH THE THREADING THAT DID NOT ALLOW THE SCREW TO ADVANCE. IT WAS DIFFICULT TO TELL IF TWO INDEPENDENT THREADS WERE JOINED OR IF THE FIRST THREAD WERE SMALLER THAN NORMAL, WOULD NOT ENGAGE. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2022. ADDITIONAL INFORMATION RECEIVED ON 10/21/2022: THIS WAS DISCOVERED DURING AN MCL PROCEDURE AND WAS COMPLETED BY FIXATING AN ONLAY USING AN AR-2324BCC-2 BIO COMPOSITE SWIVELOCK INSTEAD OF INLAY WITH THE INTERFERENCE SCREW. ADDITIONAL INFORMATION REQUESTED

  Patient problems: Insufficient Information

  MAUDE report 19238762 ↗
• MalfunctionApr 29, 2024Defective Device; Defective Device

  IT WAS REPORTED THAT DURING SURGERY THE SURGEON HAD PROBLEMS TO SCREW IN THE BIOCOMPOSITE SCREWS INTO THE KNEE. THE SCREW CRUMBLED. 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. UPDATE SWIT 31-MAR-2022: THE SCREW IS CRUMBLED WHEN REMOVING IT FROM THE SCREW DRIVER. ***UPDATE SWIT 06-APR-2022: THE SCREW CRUMBLED OUTSIDE THE PATIENT AND NO CRUMBLES GOT INTO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19200940 ↗
• MalfunctionApr 11, 2024Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING AN ALL INSIDE KNEE SURGERY THE SURGEON HAD PROBLEMS INSERTING THE SCREW INTO THE KNEE. IT WAS DRILLED TO 6 MM AND THE TENDON WAS NOT THICK. THE SCREW THREAD BECAME DEFORMED AND COULD THEREFORE NOT BE USED. 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 19089687 ↗
• MalfunctionJun 20, 2022Break

  IT WAS REPORTED THAT DURING AN ALL INSIDE KNEE SURGERY THE SURGEON HAD PROBLEMS INSERTING THE SCREWS INTO THE KNEE. IT WAS DRILLED TO 6MM AND THE TENDON WAS NOT THICK. THE FIRST SCREW HAS DEFORMED THE THREAD AND THE SECOND SCREW BROKE OFF. 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 14742815 ↗
• MalfunctionNov 30, 2021Break

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT, POSTERIOR CRUCIATE LIGAMENT AND POSTEROLATERAL CORNER RECONSTRUCTION SURGERY THE SCREW DRIVER DIDN'T FIT IN THE DEVICE. ONLY A VERY SHORT PART OF THE DRIVER GOT INSERTED IN THE DEVICE WHICH LEAD TO A BREAKAGE OF THE DEVICE WHILE PLACING IT. THE BROKEN SCREW HAD TO BE REPLACED WITH A PEEK INTERFERENCE SCREW OF ONE SIZE LARGER TO ACHIEVE PROPER FIXATION OF EACH GRAFT. THE BROKEN PARTS WERE NOT 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. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: Foreign Body In Patient

  MAUDE report 12897252 ↗
• MalfunctionMar 1, 2021Break

  IT WAS REPORTED THAT THE DEVICE BROKE INSIDE THE PATIENT WHEN SCREWING IT IN. THE BROKEN PART WAS RETRIEVED FROM THE PATIENT. THERE WAS NO HARM OR ADVERSE EVENT FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. THE KNEE ARTHROSCOPY 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. UPDATE (B)(6) 2021: IT WAS CONFIRMED THAT NO BROKEN PARTS REMAINED IN THE PATIENT.

  Patient problems: Failure of Implant

  MAUDE report 11393406 ↗
• InjuryNov 15, 2019Break

  IT WAS REPORTED THAT DURING SURGERY THE ARTHREX SCREW AR-1360C BROKE. THE BROKEN FRAGMENT WAS NOT REMOVED AND WILL REMAIN INSIDE THE PATIENT. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH A NEW DEVICE OF THE SAME PART NUMBER. IT WAS NOT NECESSARY TO CHANGE THE SURGICAL TECHNIQUE OR TO PERFORM A SECOND SURGERY.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 9327871 ↗
• InjurySep 5, 2018Break

  IT WAS REPORTED THAT DURING A DEEPENING TRACHELOPLASTY WITH MPFL PROCEDURE, THE GRACILIS TENDON WAS FIXED FEMORALLY IN THE TUNNEL WITH A BIO INTERFERENCE SCREW (TAPERED TIP, 6 X 23 MM). WHEN SCREWING IN, PART OF THE SCREW HAS BROKEN OFF. THE FRONT PART IS STILL IN THE PATIENT AND, ACCORDING TO THE DOCTOR, OFFERS SUFFICIENT STABILITY TO FIX THE TENDON. THE OTHER PART OF THE BROKEN SCREW IS RETRIEVED. SURGERY WAS COMPLETED SUCCESSFULLY WITH THE SAME DEVICE BECAUSE SURGEON CONFIRMS THAT IT HAS ENOUGH FIXATION. ACCORDING TO THE SURGEON THERE WAS NO HARM FOR PATIENT, USER OR THIRD PARTY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7845831 ↗
• InjuryNov 16, 2016Break

  IT WAS REPORTED THAT THE 6MM X 23MM BIOCOMPOSITE INTERFERENCE SCREW WAS BEING USED IN A MPFL RECONSTRUCTION PROCEDURE. THE SURGEON DRILLED THE PILOT HOLE USING A REAMER. WHEN HE WENT TO INSERT THE INTERFERENCE SCREW, THE SCREW BROKE IN HALF. HALF OF THE IMPLANT REMAINS IN THE BONE OF THE PATIENT, NOT PROUD. THE SURGEON DECIDED TO USE A CORTICAL BUTTON ON THE OTHER SIDE OF THE BROKEN IMPLANT FOR A SECONDARY FIXATION TO COMPLETE THE PROCEDURE SUCCESSFULLY. NO PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6105422 ↗