Arthrex® AR-2325BCCRecalls & reported problems

Summary

The FDA's MAUDE database contains 48 adverse event reports that list this exact device (DI 00888867026957), received between Jun 5, 2019 and Mar 10, 2026 — classified as 8 injuries, 40 malfunctions.

The most frequently reported specific device problem is “Break” (20 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 48 reports, in the reporter's own words as published by the FDA.

• InjuryMar 10, 2026Patient Device Interaction Problem

  UPDATE 16-MAR-2026. THE PATIENT CONFIRMED THAT THE INITIAL SURGERY TOOK PLACE IN THE RAPHAELSKLINIK MÜNSTER (WPO) (DR. FORKEL) AND CURRENTLY NO SECOND SURGERY IS PLANNED, ALTHOUGH THE SYMPTOMS ARE PERSISTENT SINCE (B)(6) 2025.

  Patient problems: Foreign Body Reaction

  MAUDE report 24563203 ↗
• MalfunctionFeb 6, 2026Use of Device Problem

  ON 16-JAN-2026, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA (B)(4) THAT AN AR-2324BCCT BIOCOMPOSITE SWIVELOCK ANCHOR DID NOT ADHERE TO THE BONE, BECOMING DAMAGED (CRUSHED) AND PREVENTING ITS INSERTION, SO A SECOND ANCHOR WAS OPENED. IT WAS FURTHER REPORTED THAT A QTY. 2 OF AR-2325BCC BIOCOMPOSITE SWIVELOCK ANCHORS ALSO DID NOT ADHERE TO THE BONE AND BECAME CRUSHED. THE CASE WAS COMPLETED BY PASSING TAPE. THIS WAS DISCOVERED DURING A BROSTROM PROCEDURE WITH NO PATIENT HARM. NO DELAY WAS REPORTED, NO FRAGMENTS REMAINED IN THE PATIENT, AND NO ADDITIONAL ANESTHESIA WAS REQUIRED. THE PATIENT¿S BONE QUALITY WAS REPORTED AS GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24277652 ↗
• MalfunctionFeb 6, 2026Use of Device Problem

  ON 16-JAN-2026, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA (B)(4) THAT AN AR-2324BCCT BIOCOMPOSITE SWIVELOCK ANCHOR DID NOT ADHERE TO THE BONE, BECOMING DAMAGED (CRUSHED) AND PREVENTING ITS INSERTION, SO A SECOND ANCHOR WAS OPENED. IT WAS FURTHER REPORTED THAT A QTY. 2 OF AR-2325BCC BIOCOMPOSITE SWIVELOCK ANCHORS ALSO DID NOT ADHERE TO THE BONE AND BECAME CRUSHED. THE CASE WAS COMPLETED BY PASSING TAPE. THIS WAS DISCOVERED DURING A BROSTROM PROCEDURE WITH NO PATIENT HARM. NO DELAY WAS REPORTED, NO FRAGMENTS REMAINED IN THE PATIENT, AND NO ADDITIONAL ANESTHESIA WAS REQUIRED. THE PATIENT¿S BONE QUALITY WAS REPORTED AS GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24277344 ↗
• MalfunctionFeb 3, 2026Break

  ON 13-JAN-2026, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT AN AR-2325BCC BIOCOMPOSITE SWIVELOCK BROKE UPON INSERTION. ALL BROKEN PIECES WERE REMOVED, AND THE PROCEDURE WAS COMPLETED USING ANOTHER ANCHOR. THIS ISSUE WAS DISCOVERED DURING A BROSTROM PROCEDURE PERFORMED ON (B)(6) 2026. ADDITIONAL INFORMATION WAS RECEIVED ON 20-JAN-2025: THE ANCHOR WAS REMOVED FROM THE PATIENT, AND ALL FRAGMENTS WERE SUCCESSFULLY RETRIEVED. THE PROCEDURE WAS COMPLETED USING AN AR-2325BCC BIOCOMPOSITE LABRAL SWIVELOCK ANCHOR. THERE WAS NO CASE DELAY, AND NO ADDITIONAL ANESTHESIA WAS REQUIRED.

  Patient problems: Insufficient Information

  MAUDE report 24248614 ↗
• MalfunctionJan 5, 2026Detachment of Device or Device Component

  ON 17TH DEC 2025, IT WAS REPORTED BY AN ARTHREX'S EMPLOYEE VIA AN EMAIL THAT FOR 1 UNIT OF AR-2325BCC, SUTURE ANCHOR, BIOCOMPOSITE¿ SWIVELOCK®, 3.5 X 15.8 MM, VENTED, ITS ANCHOR EYELET WAS DETACHED. THIS HAPPENED WHEN THE AR-2325BCC WAS CONNECTED TO AR-2324BCCTT AFTER REMOVING FIBERTAPE. THIS WAS DETECTED DURING AN ANKLE ATFL ON (B)(6) 2025. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY USING A REPLACEMENT OF SAME MODEL, AR-2325BCC. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23958271 ↗
• MalfunctionDec 11, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ON 25TH NOV 2025, IT WAS REPORTED BY AN ARTHREX'S EMPLOYEE VIA AN EMAIL THAT FOR 1 UNIT OF AR-2325BCC, SUTURE ANCHOR, BIOCOMPOSITE¿ SWIVELOCK®, 3.5 X 15.8 MM, VENTED, ITS ANCHOR COULD NOT BE INSERTED. IT WAS FOUND THAT THE EYELET WAS DETACHED. THIS WAS DETECTED DURING A DISITAL TRICEPS REPAIR ON (B)(6) 2025. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY USING THE COMPLAINT AR-2325BCC. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23780808 ↗
• MalfunctionDec 1, 2025Break; Break

  IT WAS REPORTED THAT DURING A MEDIAL PATELLOFEMORAL LIGAMENT RECONSTRUCTION AFTER THE IMPLANTATION OF THE ANCHOR WHILE THE SURGEON TRIED TO KNOT THE SUTURES THE TIP OF THE ANCHORS BROKE OFF. THE BROKEN PIECES WERE RETRIEVED OUT OF 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 23678938 ↗
• MalfunctionSep 18, 2025Positioning Failure; Positioning Failure

  ON (B)(6) 2025, AN ARTHREX SUBSIDIARY EMPLOYEE REPORTED VIA EMAIL THAT AN AR-2325BCC BIOCOMPOSITE LABRAL SWIVELOCK ANCHOR COULD NOT BE INSERTED AFTER DRILLING AND TAPPING THE MIDDLE CUNEIFORM BONE. THE BONE SOCKET WAS PREPARED USING A 2.9 MM HOLLOW DRILL (NO DETAILED INFORMATION AVAILABLE) AND AN AR-1678-03 SWIVELOCK BONE TAP, 3.5 MM (NO BATCH INFORMATION PROVIDED). AFTER THE INITIAL INSERTION ATTEMPT FAILED, A NEW BONE HOLE WAS DRILLED, AND A REPLACEMENT AR-2325BCC BIOCOMPOSITE LABRAL SWIVELOCK ANCHOR WAS SUCCESSFULLY USED TO COMPLETE THE PROCEDURE. THE BONE QUALITY WAS ASSESSED AS GOOD. THERE WAS NO SIGNIFICANT DELAY, NO ADDITIONAL ANESTHESIA WAS ADMINISTERED, AND NO BREAKAGE OCCURRED WITHIN THE PATIENT DURING USE. THIS ISSUE WAS DISCOVERED DURING A LISFRANC JOINT INJURY REPAIR PERFORMED ON (B)(6) 2025, WITH NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23086402 ↗
• MalfunctionSep 12, 2025Break; Crack; Break; Crack

  ON 3/19/2025, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA EMAIL THAT AN AR-2325BCC BIOCOMPOSITE SWIVELOCK SCREW CRACKED DURING INSERTION. THE CASE WAS COMPLETED USING ANOTHER AR-2325BCC BIOCOMPOSITE SWIVELOCK. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2025. ADDITIONAL INFORMATION WAS RECEIVED ON 4/7/2025: IT WAS REPORTED THAT THE SAME ISSUE OCCURRED WITH TWO AR-2325BCC BIOCOMPOSITE SWIVELOCK DEVICES DURING AN ELBOW PROCEDURE. BOTH SCREWS CRACKED DURING INSERTION; HOWEVER, ALL FRAGMENTS WERE SUCCESSFULLY REMOVED FROM THE PATIENT. THE CASE PROCEEDED WITHOUT DELAY, AND NO ADDITIONAL ANESTHESIA WAS REQUIRED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23043329 ↗
• MalfunctionAug 21, 2025Break; Break

  ON 8/4/2025, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA EMAIL THAT AN AR-2325BCC BIOCOMPOSITE SWIVELOCK EYELET BROKE OFF DURING INSERTION. THIS WAS DISCOVERED DURING AN MPFL PROCEDURE ON (B)(6) 2025. THE CASE WAS COMPLETED USING ANOTHER AR-2325BCC BIOCOMPOSITE SWIVELOCK. THE PATIENT WAS NOT AFFECTED. ADDITIONAL INFORMATION WAS RECEIVED ON 08/12/2025: ALL FRAGMENTS OF THE EYELET WERE RETRIEVED. THE CASE WAS NOT DELAYED, AND NO ADDITIONAL ANESTHESIA WAS ADMINISTERED TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22864231 ↗
• MalfunctionAug 11, 2025Break; Break

  ON 07/22/2025, AN ARTHREX SUBSIDIARY EMPLOYEE REPORTED VIA EMAIL THAT AN AR-2325BCC BIOCOMPOSITE LABRAL SWIVELOCK ANCHOR EXPERIENCED A SCREW FRACTURE. THE BREAK OCCURRED AFTER THE THREAD WAS TAPPED TWICE TO ACCOMMODATE THE HARDNESS OF THE BONE BEFORE INSERTION. THE CASE WAS COMPLETED WITH A REPLACEMENT AR-2325BCC BIOCOMPOSITE LABRAL SWIVELOCK ANCHOR. THIS WAS DISCOVERED DURING AN MPFL PROCEDURE ON (B)(6) 2025, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION WAS RECEIVED ON 07/29/2025: THE CASE WAS NOT DELAYED, AND NO ADDITIONAL ANESTHESIA WAS ADMINISTERED. ALL FRAGMENTS WERE RETRIEVED FROM THE PATIENT. NO ADVERSE EFFECTS WERE REPORTED ON OR AFTER THE SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22770460 ↗
• MalfunctionJun 2, 2025Crack; Crack

  ADDITIONAL INFORMATION WAS RECEIVED ON 05/30/2025: ANOTHER AR-2325BCC BIOCOMPOSITE LABRAL SWIVELOCK ANCHOR WAS USED AS A REPLACEMENT FOR THE BROKEN IMPLANT THAT WAS REMOVED AND REPLACED WITH A NEW PRODUCT. THE AR-2325BCC BIOCOMPOSITE LABRAL SWIVELOCK ANCHOR THAT WAS USED AS A REPLACEMENT HAD NO BREAKAGE. NO OTHER DRILL HOLE WAS MADE. THERE WAS NO CASE DELAY OR ADDED ANESTHESIA ADMINISTERED TO THE PATIENT, AND NO ADVERSE EFFECTS ON OR AFTER THE SURGERY WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22123355 ↗
• MalfunctionMay 30, 2025Crack; Positioning Failure; Crack; Positioning Failure

  ADDITIONAL INFORMATION WAS RECEIVED ON 05/30/2025: ANOTHER AR-2325BCC BIOCOMPOSITE LABRAL SWIVELOCK ANCHOR WAS USED AS A REPLACEMENT FOR THE BROKEN IMPLANT THAT WAS REMOVED AND REPLACED WITH A NEW PRODUCT. THE AR-2325BCC BIOCOMPOSITE LABRAL SWIVELOCK ANCHOR THAT WAS USED AS A REPLACEMENT HAD NO BREAKAGE. NO OTHER DRILL HOLE WAS MADE. THERE WAS NO CASE DELAY OR ADDED ANESTHESIA ADMINISTERED TO THE PATIENT, AND NO ADVERSE EFFECTS ON OR AFTER THE SURGERY WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22116470 ↗
• MalfunctionFeb 10, 2025Break; Break

  ON 1/30/2025, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA EMAIL THAT AN AR-2325BCC BIOCOMPOSITE SWIVELOCK ANCHOR TAPES THAT WAS THREADED THROUGH THE EYELET SPUN AROUND AND DID NOT GO INTO THE BONY FORAMEN. THE CASE WAS COMPLETED USING ANOTHER AR-2325BCC BIOCOMPOSITE SWIVELOCK. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2025. ADDITIONAL INFORMATION RECEIVED ON 2/4/2025: THIS WAS DISCOVERED DURING A SLAP REPAIR. EVERYTHING WAS REMOVED FROM THE PATIENT BEFORE USING THE NEW BIOCOMPOSITE SWIVELOCK TO COMPLETE THE CASE. THE CASE WAS NOT DELAYED, AND ADDITIONAL ANESTHESIA WAS NOT NEEDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21346073 ↗
• MalfunctionDec 12, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  ON 11/15/2024, IT WAS REPORTED BY A DISTRIBUTOR VIA EMAIL THAT AN AR-2325BCC BIOCOMPOSITE SWIVELOCK WAS STUCK. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2024.

  Patient problems: Insufficient Information

  MAUDE report 20918079 ↗
• MalfunctionNov 6, 2024Break; Break

  ON (B)(6) 2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-2325BCC BIOCOMPOSITE SWIVELOCK ANCHOR BROKE DURING INSERTION. THE SURGEON DRILLED AND TAPPED THE ANCHOR IN, BUT THE ANCHOR STILL BROKE. THIS WAS DISCOVERED DURING A PROCEDURE TO HELP STABILIZE A SYNDESMOSIS JOINT. THE SURGEON UPSIZED THE DRILL AND INSERTED A BACKUP ANCHOR TO COMPLETE THE CASE. THE CASE WAS NOT DELAYED. ADDITIONAL INFORMATION RECEIVED ON 10/29/2024: THE PROCEDURE TOOK PLACE ON (B)(6) 2024. ALL BROKEN FRAGMENTS WERE REMOVED FROM INSIDE THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20620593 ↗
• MalfunctionJun 7, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON 04/19/2023, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT AN AR-2325BCC BIOCOMPOSITE SWIVELOCK ANCHOR PULLED OUT WHEN THE SCREWDRIVER WAS BEING REMOVED. AN AR-7237 FIBERTAPE WAS PLACED IN A BONE HOLE CREATED USING A 3.0MM DRILL AND A 3.5MM TAP FROM AN AR-8979DS KIT IN THE LOADED TALAR PROCESS OF THE CALCANEUS. THE IMPLANT WAS INSERTED AS USUAL, AND AN ATTEMPT WAS MADE TO PULL THE SCREWDRIVER OUT, BUT IT DID NOT PULL OUT. WHEN THE SURGEON TRIED TO REMOVE THE SCREWDRIVER AGAIN, THE ANCHOR ALSO PULLED OUT. THIS OCCURRED IN THE SPRING LIGAMENT INTERNALBRACE DURING AN FDL MIGRATION PROCEDURE ON (B)(6) 2023. THE CASE WAS COMPLETED USING ANOTHER AR-2325BCC BIOCOMPOSITE SWIVELOCK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19492156 ↗
• MalfunctionMay 13, 2024Defective Device; Defective Device

  IT WAS REPORTED THAT DURING A SURGERY THE ANCHOR COULD NOT BE SCREWED IN AND ALSO NOT PLACED AS IT DID NOT CAME OFF THE DRIVER. 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. 23-DEC-2022 UPDATE DW. FURTHER INFORMATION WERE PROVIDED THAT THE REPORTED EVENT HAPPENED DURING AN ANTEROLATERAL LIGAMENT RECONSTRUCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19303197 ↗
• MalfunctionMay 13, 2024Unintended Movement; Unintended Movement

  ON 6/7/2022, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT (2) AR-2325BCC BIOCOMPOSITE SWIVELOCK PULLED OUT OF IMPLANTATION SITE AFTER INSERTION. A THIRD ONE WAS USED AND ABLE TO COMPLETE THE CASE WITHOUT FURTHER ISSUES. THIS WAS DISCOVERED DURING A FOOT AND ANKLE PROCEDURE ON (B)(6) 2022.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19299390 ↗
• MalfunctionMay 13, 2024Unintended Movement; Unintended Movement

  ON 6/7/2022, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT (2) AR-2325BCC BIOCOMPOSITE SWIVELOCK PULLED OUT OF IMPLANTATION SITE AFTER INSERTION. A THIRD ONE WAS USED AND ABLE TO COMPLETE THE CASE WITHOUT FURTHER ISSUES. THIS WAS DISCOVERED DURING A FOOT AND ANKLE PROCEDURE ON (B)(6) 2022.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19299315 ↗
• MalfunctionApr 24, 2024Damaged Thread; Damaged Thread

  IT WAS REPORTED THAT DURING AN INTERNAL BRACE PROCEDURE, THE PATIENTS BONES WERE TOO HARD AND THE SURGEON COULD NOT PLACE THE AR-2325BCC. WHEN THE SURGEON REMOVED THE AR-2325BCC, THE THREAD WAS CRUSHED. NO ADVERSE EFFECT ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19171362 ↗
• MalfunctionApr 22, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED ON (B)(6) 2022 BY A ARTHREX EMPLOYEE VIA EMAIL THAT AN AR-2325BCC SWIVELLOCK ANCHOR BACKED OUT. THIS WAS DISCOVERED DURING A CASE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19153030 ↗
• MalfunctionApr 10, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED ON 08/18/2022 BY A ARTHREX EMPLOYEE VIA EMAIL THAT AN AR-2325BCC SWIVELLOCK ANCHOR BACKED OUT. THIS WAS DISCOVERED DURING A CASE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19082124 ↗
• MalfunctionMar 7, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  ON 2/21/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-2325BCC SUTURE ANCHOR, BIOCOMPOSITE SWIVELOCK EYELET WOULD NOT COME OUT OF THE INSERTER AND WAS STUCK AND THEREFORE UNABLE TO IMPLANT INTO THE PATIENT. THE CASE WAS COMPLETED USING A DIFFERENT SIZE PRODUCT, AR-2324BCC SUTURE ANCHOR, BIOCOMPOSITE SWIVELOCK, TO COMPLETE THE CASE WITH NO ISSUES. THERE WAS NO DELAY IN THE CASE. THIS WAS DISCOVERED DURING AN MPFL RECONSTRUCTION PROCEDURE ON (B)(6) 2024, WITH NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18856869 ↗
• MalfunctionMar 7, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  ON 2/21/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-2325BCC SUTURE ANCHOR, BIOCOMPOSITE SWIVELOCK EYELET WOULD NOT COME OUT OF THE INSERTER AND WAS STUCK AND THEREFORE UNABLE TO IMPLANT INTO THE PATIENT. THE CASE WAS COMPLETED USING A DIFFERENT SIZE PRODUCT, AR-2324BCC SUTURE ANCHOR, BIOCOMPOSITE SWIVELOCK, TO COMPLETE THE CASE WITH NO ISSUES. THERE WAS NO DELAY IN THE CASE. THIS WAS DISCOVERED DURING AN MPFL RECONSTRUCTION PROCEDURE ON (B)(6) 2024, WITH NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18856834 ↗