Arthrex® AR-1360C-CPRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00888867014015), received between Oct 31, 2017 and Feb 4, 2025 — classified as 3 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 4, 2025Break; Break

  ON 01/13/2025, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA EMAIL THAT THE ANCHOR FROM AN AR-1360C-CP MPFL BIOCOMPOSITE IMPLANT SYSTEM, BROKE. THE SURGEON DID NOT HAVE THE APPROPRIATE INSTRUMENTATION FOR THE CORRECT ANCHOR PLACEMENT. HALF OF THE SCREW REMAINED IN THE PATIENT; THE OTHER HALF WAS REMOVED. THE CASE WAS COMPLETED BY OPENING A NEW AR-1360C-CP MPFL BIOCOMPOSITE IMPLANT SYSTEM. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2025. ADDITIONAL INFORMATION RECEIVED ON 1/22/2025: THIS WAS DISCOVERED DURING A MEDIAL PATELLOFEMORAL LIGAMENT RECONSTRUCTION PROCEDURE. THE 6 MM BIOCOMPOSITE INTERFERENCE SCREW WAS WHAT BROKE IN THE PATIENT. THE AR-1360C-CP MPFL BIOCOMPOSITE IMPLANT SYSTEM WAS NOT MISSING ANY INSTRUMENTATION, HOWEVER, THE SURGEON DID NOT HAVE THE APPROPRIATE DRIVER TO IMPLANT THE INTERFERENCE SCREW, WHICH ENDED UP BREAKING IN THE PATIENT. THE CASE WAS ACTUALLY COMPLETED BY OPENING AN AR-2324BCC BIOCOMPOSITE SWIVELOCK C IN PLACE OF THE INTERFERENCE SCREW. THE CASE WAS DELAYED BETWEEN THIRTY TO FORTY MINUTES; HOWEVER, THE PATIENT WAS ALREADY HAD GENERAL ANESTHESIA ADMINISTERED, A BOOSTER WAS NOT NECESSARY.

  Patient problems: Foreign Body In Patient

  MAUDE report 21304771 ↗
• MalfunctionJul 15, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A MPFL SURGERY WITH TWO 4.75 SWIVELOCK, FIBERTAPE AND TIGHTROPE RT THE FIBERTAPE PULLED OUT FROM ONE OF THE SWIVELOCK ANCHORS IN THE PATELLA. THE SURGEON USED LARGER SCREWS IN THE PATELLA, A SCREW IN THE FEMUR AND SYNTHETIC GRAFT. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A DIFFERENT DEVICE WITH THE PART NUMBER AR-1555BC. IT WAS NOT NECESSARY TO DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19740493 ↗
• MalfunctionAug 8, 2022Break

  IT WAS REPORTED THAT DURING A MEDIAL PATELLOFEMORAL LIGAMENT RENEWAL (MPFL) SURGERY THE ANCHOR BROKE WHEN TIGHTENING THE SUTURES AND TORE OUT. 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 15183116 ↗
• InjuryAug 24, 2020Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THE PATIENT DEVELOPED AN INFECTION AFTER A MEDIAL PATELLA FEMORAL TENDON WITH ALLOGRAFT PROCEDURE ON (B)(6) 2020. DURING THE (B)(6) 2020 PROCEDURE THE FOLLOWING ARTHREX PRODUCT WAS IMPLANTED: AR-1360C-CP (LOT 10435919). IN ADDITION, A JRF VERSAGRAFT (VRG-OO1) WAS USED. THE PATIENT DEVELOPED AN INFECTION AND ON (B)(6) 2020 THE SURGEON WENT BACK IN AND REMOVED THE IMPLANT AND GRAFT. SURGEON THEN CLEANED AND DRAINED THE WOUND. CULTURES WERE TAKEN AT THE TIME OF SECOND SURGERY AND NO NEW PRODUCTS WERE IMPLANTED. PATIENT WE CONTINUE TO BE OBSERVED DURING THE HEALING PROCESS TO INSURE THE WOUND HEALS AND REMAINS FREE OF INFECTION. THE CULTURE RESULTS WERE POSITIVE FOR (B)(6).

  Patient problems: Bacterial Infection

  MAUDE report 10443132 ↗
• InjuryMar 19, 2019Break; Detachment of Device or Device Component

  IT WAS REPORTED DURING AN MPFL RECONSTRUCTION PROCEDURE, THE SURGEON WAS USING THE AR-1360C-CP MPFL BIOCOMPOSITE IMPLANT SYSTEM (LOT: 10212210). THE SURGEON IMPLANTED TWO AR-2324BCC SUTURE ANCHOR BIOCOMPOSITE SWIVELOCKS IN THE PATELLA. WHEN THE SURGEON INSERTED THE ANCHOR AND TENODESED THE SEMI-T ALLOGRAFT INTO THE MOST PROXIMAL 4.5MM SOCKET ON THE PATELLA, THE 4.75MM SWIVELOCK INSERTED COMPLETELY, BUT THE MOST PROXIMAL 2-3MM OF THE ANCHOR BROKE AND CAME OFF WHEN THE SWIVELOCK DRIVER WAS REMOVED. THE BROKEN PIECE WAS PRESENT OUTSIDE THE JOINT AND STILL ON THE SWIVELOCK DRIVER, AND WAS EASILY RETRIEVED. THE REP STATED THE REMAINING PORTION OF THE SWIVELOCK ANCHOR WAS SEATED INTO THE SOCKET WITHOUT ISSUE, DESPITE THE PROXIMAL PORTION OF THE ANCHOR BREAKING. THE REST OF THE TECHNIQUE WAS PERFORMED WITHOUT ISSUE. A TOTAL OF THREE IMPLANTS THAT CAME WITHIN THE AR-1360C-CP WERE USED. ONLY THE ONE 4.75MM SWIVELOCK BROKE. THE OTHER SWIVELOCK AND 6X23MM INTERFERENCE SCREW WORKED FINE AND HAD NO ISSUES. NO PUNCH OR TAP WAS USED FOR EITHER SOCKET. THE ONLY DRILL USED FOR EACH SOCKET WAS THE 4.5MM REAMER THAT CAME WITHIN THE KIT. THE QUALITY OF BONE WAS HARD. ADDITIONAL INFORMATION RECEIVED ON

  Patient problems: Failure of Implant

  MAUDE report 8432275 ↗
• InjuryOct 31, 2017Difficult to Insert; Unstable

  IT WAS REPORTED THAT THE MPFL DRIVER WAS UNAVAILABLE DURING SURGERY BUT THE SURGEON PROCEEDED WITH ANOTHER DRIVER TO INSERT THE SCREW INSTEAD WITH THE SHAFT RETRACTED (AR-1540DB). THE SURGEON STRUGGLED TO INSERT THE SCREW BECAUSE HE ONLY USED THE TIP OF THE DRIVER TO IMPLANT. THE ACUTE ANGLE X-RAY TEMPLATE WAS NOT USED. SCREW WAS INSERTED AND THE PATIENT WAS STABLE IMMEDIATELY POST-OP. A REVISION SURGERY WAS NECESSARY DUE TO INSTABILITY, THE INTERFERENCE SCREW WAS FOUND BROKEN AT PROXIMAL END. THE TIP WILL REMAIN INSIDE THE PATIENT.

  Patient problems: No Code Available

  MAUDE report 6989810 ↗