Arthrex® AR-2325BCC-1Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00888867283626), received between Nov 19, 2018 and Mar 31, 2026 — classified as 3 injuries, 14 malfunctions.

The most frequently reported specific device problem is “Break” (8 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 31, 2026Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC SURGERY WHILE THE SURGEON SCREWED IN THE IMPLANT THE DEVICE BROKE OFF. 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. UPDATE 12-MAR-2026: FURTHER INFORMATION WAS PROVIDED THAT THE BROKEN PIECE WAS RETRIEVED OUT OF THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24741893 ↗
• MalfunctionMar 9, 2026Break

  IT WAS REPORTED THAT DURING A LABRAL REPAIR SURGERY THE ANCHOR BROKE. ALL PARTS 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 24543902 ↗
• MalfunctionDec 17, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING THE LABRAL REPAIR, THE ANCHOR TORN. 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. 09-DEC-2025 MAJUNG - FURTHER INFORMATION WAS RECEIVED FROM ARTHREX CZ: NO FRAGMENTS REMAINED IN THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23829766 ↗
• MalfunctionAug 11, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED DURING THE LABRAL REPAIR SURGERY THAT THE TIP OF THE DEVICE (AR-2325BCC-1 - LOT: 15394596) DETACHED DURING INSERTION. THE FELL APART TIP WAS RETRIEVED FROM THE PATIENT. 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: Insufficient Information

  MAUDE report 22771624 ↗
• MalfunctionMay 21, 2025Break; Break

  IT WAS REPORTED THAT DURING A LABRAL REPAIR SURGERY THE ANCHOR TIP BROKE DURING INSERTION. THE BROKEN PIECES WERE RETRIEVED FROM THE PATIENT. UPDATE: (B)(6) 14-MAY-2025. 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 22062738 ↗
• MalfunctionJan 13, 2025Break; Break

  IT WAS REPORTED THAT DURING A LABRUM STABILIZATION SURGERY THE ANCHOR BROKE DURING INSTALLATION, IT BROKE QUITE EASILY. 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 21143350 ↗
• MalfunctionJun 13, 2024Failure to Advance; Failure to Advance

  ON THE 12TH MARCH 2023 IT WAS REPORTED VIA EMAIL THAT AN (SUTURE ANCHOR, BIOCOMPOSITE¿ SWIVELOCK®, 3.5 X 15.8 MM, VENTED) - (BATCH#14992663) HAD AN ISSUE WHERE THE SURGEON WAS PERFORMING A LATERAL LIGAMENT STABILISATION AND WHEN HE WAS TRYING TO INSERT THE LIMBS OF THE FIBERTAPE INTO THE EYELET OF THE 3.5 SWIVELOCK (AR-2325BCC), THEY WOULD NOT FIT. HE TRIED SEVERAL TIMES TO PULL IT THROUGH TO NO AVAIL. THEY DECIDED TO OPEN A SECOND ANCHOR AND THE TAPE PASSED THROUGH THE EYELET WITHOUT ANY ISSUES. THERE WAS A CASE AND PATIENT INVOLVED. ANOTHER ANCHOR WAS OPENED TO COMPLETE THE CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19528296 ↗
• MalfunctionMay 3, 2024Break; Break

  IT WAS REPORTED THAT DURING A LABRUM STABILIZATION SURGERY THE DEVICE DID NOT WORK, THERE WAS NO ACTION. 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. UPDATE SWIT 11-APR-2024: THE METAL PART OF SWIVELOCK JUST BROKE DURING THE IMPLANTATION, THE SURGERY WAS NOT FINISHED WITH DEFECTIVE DEVICE, THEY USED ANOTHER ONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19236884 ↗
• MalfunctionMay 1, 2024Defective Device; Defective Device

  IT WAS REPORTED THAT DURING A MEDIAL PATELLOFEMORAL LIGAMENT (MPFL) SURGERY AFTER PLACING THE ANCHOR IT DID NOT HOLD SECURELY. 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 19220688 ↗
• MalfunctionFeb 12, 2024Fitting Problem; Fitting Problem

  IT WAS REPORTED THAT DURING A MPFL RECONSTRUCTION SURGERY THE ANCHOR COULD NOT PROPERLY FIXATED WITH THE TRANSPLANT. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18691442 ↗
• MalfunctionDec 22, 2023Device Dislodged or Dislocated; Failure to Auto Stop; Device Dislodged or Dislocated; Failure to Auto Stop

  IT WAS REPORTED THAT DURING A SURGERY THE SWIVELOCK ANCHORS COULD NOT BE FIXED ONE AFTER THE OTHER. ANCHORS COULD BE SCREWED IN DIRECTLY AFTER DRILLING BUT CAME OUT OF THE BONE AGAIN IMMEDIATELY. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A DIFFERENT DEVICE, AR-2323-1. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18381373 ↗
• MalfunctionDec 21, 2023Positioning Failure; Device Dislodged or Dislocated; Positioning Failure; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A SURGERY THE SWIVELOCK ANCHORS COULD NOT BE FIXED ONE AFTER THE OTHER. ANCHORS COULD BE SCREWED IN DIRECTLY AFTER DRILLING BUT CAME OUT OF THE BONE AGAIN IMMEDIATELY. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A DIFFERENT DEVICE, AR-2323-1. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18374497 ↗
• MalfunctionDec 21, 2023Break; Device Dislodged or Dislocated; Break; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A SURGERY THE SWIVELOCK ANCHORS COULD NOT BE FIXED ONE AFTER THE OTHER. ANCHORS COULD BE SCREWED IN DIRECTLY AFTER DRILLING BUT CAME OUT OF THE BONE AGAIN IMMEDIATELY. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A DIFFERENT DEVICE, AR-2323-1. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY. UPDATE SWIT 27-NOV-2023: THE SCREW BROKE IN THE MIDDLE. THE BROKEN SCREW WITH ITS ANCHOR WAS PULLED OUT AND RETRIEVED FROM PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18374349 ↗
• InjuryOct 27, 2023Expiration Date Error; Expiration Date Error

  PER SALES REPRESENTATIVE, THE SURGEON REPORTED THAT HE IMPLANTED AN EXPIRED IMPLANT INTO THE PATIENT IN JULY. THE PATIENT GOT AN INFECTION BUT IT IS UNCLEAR IF THE INFECTION WAS CAUSED BY THE EXPIRED IMPLANT. PER SYSTEM, THE EXPIRATION DATE IS 31-DEC-2023 AND WAS NOT EXPIRED DURING IMPLANTATION. ***UPDATE (B)(6) 2023 NROE: FURTHER INFORMATION REVEALED THAT THE PART ID WAS ENTERED INCORRECTLY. THE EXPIRATION DATE OF THE CORRECT PART ID IS 31-MAY-2023, SO THE IMPLANT WAS IN FACT EXPIRED DURING IMPLANTATION. THE CUSTOMER WAS REPEATEDLY INFORMED THAT THE IMPLANT HAD EXPIRED. THE PROCEDURE PERFORMED WAS AN AC JOINT REPAIR SURGERY. AN ADDITIONAL SURGERY WAS PERFORMED AT THE END OF AUGUST DUE TO THE INFECTION. ***UPDATE (B)(6) 2023 NROE: ADDITIONAL INFORMATION WAS PROVIDED AND REVEALED THAT IN THE ADDITIONAL SURGERY IN AUGUST THE INFECTION WAS TREATED. ALSO IT WAS REPORTED THAT THREE OTHER ARTHREX IMPLANTS WERE IMPLANTED IN THE INITIAL SURGERY IN JULY. THE IMPLANTS WERE NOT REMOVED. NO FURTHER INFORMATION RECEIVED.

  Patient problems: Unspecified Infection

  MAUDE report 18023719 ↗
• InjurySep 29, 2023Expiration Date Error; Expiration Date Error

  PER SALES REPRESENTATIVE THE SURGEON REPORTED THAT HE IMPLANTED AN EXPIRED IMPLANT INTO THE PATIENT IN JULY. THE PATIENT GOT AN INFECTION BUT IT IS UNCLEAR IF THE INFECTION WAS CAUSED BY THE EXPIRED IMPLANT. PER SYSTEM THE EXPIRATION DATE IS 31-DEC-2023 AND WAS NOT EXPIRED DURING IMPLANTATION. UPDATE 14-SEP-2023 NROE: FURTHER INFORMATION REVEALED THAT THE PART ID WAS ENTERED INCORRECTLY. THE EXPIRATION DATE OF THE CORRECT PART ID IS 31-MAY-2023, SO THE IMPLANT WAS IN FACT EXPIRED DURING IMPLANTATION. THE CUSTOMER WAS REPEATEDLY INFORMED THAT THE IMPLANT HAD EXPIRED. THE PROCEDURE PERFORMED WAS AN AC JOINT REPAIR SURGERY. AN ADDITIONAL SURGERY WAS PERFORMED AT THE END OF AUGUST DUE TO THE INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 17845950 ↗
• MalfunctionAug 15, 2022Break

  IT WAS REPORTED THAT DURING A ELBOW SURGERY THE DEVICE 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 15223828 ↗
• InjuryNov 19, 2018Break; Difficult to Remove

  IT WAS REPORTED THAT DURING A MPFL - PATELLA STABILISATION. THE SCREW BROKE AT THE FIRST TURN. THE REMAINING PART STILL LIES IN THE SOFT TISSUE AND COULD NOT BE RECOVERED. A SWIVELOCK 3.5 WAS USED AGAIN. 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. UPDATED INFORMATION OBTAINED (B)(6) 2018: THE FRAGMENT WAS NOT RETRIEVED, IT IS LOCATED IN THE SOFT TISSUE AREA OF THE QUADRICEPS TENDON AND CAN NOT MOVE. NO X-RAY IS AVAILABLE. ACCORDING TO THE DOCTOR NO IMPAIRMENT OR CONSEQUENTIAL DAMAGES IS FORESEEABLE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8083807 ↗