Arthrex® AR-2324BCCTRecalls & reported problems

Summary

The FDA's MAUDE database contains 59 adverse event reports that list this exact device (DI 00888867026841), received between Jul 25, 2017 and Sep 22, 2026 — classified as 11 injuries, 48 malfunctions.

The most frequently reported specific device problem is “Break” (35 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 59 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 22, 2026Defective Device

  On 8th September 2026, it was reported by an Arthrex's employee via an Email that 1 unit of AR-2324BCCT, Suture Anchor, BioComposite SwiveLock® C Vented, 4.75 x 19.1 mm, with FiberTape® Loop (Blue), was damaged during its anchor insertion procedure.This was detected during a LUCL procedure on (b)(6) 2026. The procedure was completed successfully by replacing to a substitute part. There was no patient harm.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50854019 ↗
• MalfunctionSep 15, 2026Material Deformation

  On 1st September 2026, it was reported by an Arthrex's employee via an Email that for 1 unit of AR-2324BCCT, Suture Anchor, BioComposite SwiveLock® C Vented, 4.75 x 19.1 mm, with FiberTape® Loop (Blue), its anchor deformed during insertion.This was detected during an arthroscopic meniscus repair surgery of the knee on (b)(6) 2026. The procedure was completed successfully by using a new AR-2324BCCT. There was no patient harm, and no secondary surgery was needed.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50773388 ↗
• MalfunctionApr 8, 2026Material Deformation

  ON 17TH MARCH 2026, IT WAS REPORTED BY AN ARTHREX'S EMPLOYEE VIA AN EMAIL THAT FOR 1 UNIT OF AR-2324BCCT, SUTURE ANCHOR, BIOCOMPOSITE SWIVELOCK® C VENTED, 4.75 X 19.1 MM, WITH FIBERTAPE® LOOP (BLUE), ITS ANCHOR DEFORMS DURING INSERTION. THIS WAS DETECTED DURING AN OPEN REDUCTION AND INTERNAL FIXATION OF TIBIAL FRACTURES WITH PLATES SURGERY ON (B)(6) 2026. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY USING ANOTHER NEW AR-2324BCCT. THERE WERE NO PATIENT HARM AND NO SECONDARY PROCEDURE NEEDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24816678 ↗
• MalfunctionMar 19, 2026Device Dislodged or Dislocated

  ON 27TH FEB 2026, IT WAS REPORTED BY AN ARTHREX'S EMPLOYEE VIA AN EMAIL THAT FOR 1 UNIT OF AR-2324BCCT, SUTURE ANCHOR, BIOCOMPOSITE SWIVELOCK® C VENTED, 4.75 X 19.1 MM, WITH FIBERTAPE® LOOP (BLUE), ITS ANCHOR PULLED OUT DURING INSERTION. THIS WAS DETECTED DURING A RIGHT KNEE ARTHROSCOPIC ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION SURGERY ON (B)(6) 2025. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY USING ANOTHER NEW AR-2324BCCT. THERE WERE NO PATIENT HARM AND NO SECONDARY PROCEDURE NEEDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24637391 ↗
• 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 24277417 ↗
• MalfunctionFeb 4, 2026Break

  ON 15TH JAN 2026, IT WAS REPORTED BY AN ARTHREX'S EMPLOYEE VIA AN EMAIL THAT FOR 1 UNIT OF AR-2324BCCT, SUTURE ANCHOR, BIOCOMPOSITE SWIVELOCK® C VENTED, 4.75 X 19.1 MM, WITH FIBERTAPE® LOOP (BLUE), ITS ANCHOR BROKE DURING INSERTION. THIS WAS DETECTED DURING A RECONSTRUCTION OF THE ANTERIOR CRUCIATE LIGAMENT OF THE KNEE JOINT ON (B)(6) 2025. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY USING ANOTHER NEW AR-2324BCCT. THERE WERE NO PATIENT HARM AND NO SECONDARY PROCEDURE NEEDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24259979 ↗
• MalfunctionFeb 4, 2026Break

  ON 15TH JAN 2026, IT WAS REPORTED BY AN ARTHREX'S EMPLOYEE VIA AN EMAIL THAT FOR 1 UNIT OF AR-2324BCCT, SUTURE ANCHOR, BIOCOMPOSITE SWIVELOCK® C VENTED, 4.75 X 19.1 MM, WITH FIBERTAPE® LOOP (BLUE), ITS ANCHOR BROKE DURING INSERTION. THIS WAS DETECTED DURING A ROTATOR CUFF REPAIR SURGERY ON (B)(6) 2025. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY USING ANOTHER NEW AR-2324BCCT. THERE WERE NO PATIENT HARM AND NO SECONDARY PROCEDURE NEEDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24259695 ↗
• MalfunctionDec 18, 2025Break; Break

  ON 28TH NOV 2025, IT WAS REPORTED BY AN ARTHREX'S EMPLOYEE VIA AN EMAIL THAT FOR 1 UNIT OF AR-2324BCCT, SUTURE ANCHOR, BIOCOMPOSITE SWIVELOCK® C VENTED, 4.75 X 19.1 MM, WITH FIBERTAPE® LOOP (BLUE), ITS ANCHOR BROKE DURING INSERTION. THIS WAS DETECTED DURING A POSTERIOR CRUCIATE LIGAMENT AVULSION FRACTURE OF THE INTERCONDYLAR SPINE SURGERY ON (B)(6) 2025. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY USING ANOTHER NEW AR-1927BCF-45. THERE WERE NO PATIENT HARM AND NO SECONDARY PROCEDURE NEEDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23837062 ↗
• MalfunctionNov 5, 2025Break; Break

  ADDITIONAL INFORMATION WAS RECEIVED ON 11/3/2025: DURING A PROCEDURE, IT WAS REPORTED THAT ONLY THE ANCHOR BROKE; THE EYELET REMAINED INTACT. ALL DETACHED FRAGMENTS WERE ACCOUNTED FOR AND SUCCESSFULLY RETRIEVED FROM THE PATIENT. THE SURGERY WAS NOT DELAYED, AS AN ADDITIONAL AR-2324BCCT BIOCOMPOSITE SWIVELOCK C WAS READILY AVAILABLE. NO ADDITIONAL ANESTHESIA WAS ADMINISTERED TO THE PATIENT. NO ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED DURING OR FOLLOWING THE PROCEDURE DUE TO THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23475508 ↗
• MalfunctionOct 20, 2025Break; Break

  ON 10/10/2025, AN ARTHREX SUBSIDIARY EMPLOYEE REPORTED VIA EMAIL THAT AN AR-2324BCCT BIOCOMPOSITE SWIVELOCK SUTURE ANCHOR BEGAN TO BREAK DURING INSERTION. THE BROKEN PIECES WERE RETRIEVED FROM THE PATIENT, AND THE PROCEDURE WAS COMPLETED. NO ADDITIONAL DETAILS WERE PROVIDED. THE ISSUE OCCURRED DURING A KNEE ARTHROSCOPY WITH ACL RECONSTRUCTION PROCEDURE ON (B)(6) 2025, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED ON 10/14/2025.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23334988 ↗
• MalfunctionSep 19, 2025Break; Break

  ON 1ST SEP 2025, IT WAS REPORTED BY AN ARTHREX'S EMPLOYEE VIA AN EMAIL THAT FOR 1 UNIT OF AR-2324BCCT, SUTURE ANCHOR, BIOCOMPOSITE SWIVELOCK® C VENTED, 4.75 X 19.1 MM, WITH FIBERTAPE® LOOP (BLUE), ITS ANCHOR BROKE DURING INSERTION. THIS WAS DETECTED DURING A ROTATOR CUFF REPAIR SURGERY ON (B)(6) 2025. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY USING ANOTHER NEW AR-2324BCCT. THERE WERE NO PATIENT HARM AND NO SECONDARY PROCEDURE NEEDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23094468 ↗
• MalfunctionSep 12, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON 09/05/2025, AN ARTHREX SUBSIDIARY EMPLOYEE REPORTED VIA EMAIL THAT AN AR-2324BCCT BIOCOMPOSITE SWIVELOCK C VENTED SUTURE ANCHOR WAS INTENDED FOR USE IN A BICEPS REINSERTION PROCEDURE. DURING INSERTION INTO THE CANNULA, THE ANCHOR SLIPPED OUT. IT HAD NOT YET BEEN PLACED AT THE PERFORATION SITE OR TENSIONED. THE PICK WAS OBSERVED TO BE IN POOR CONDITION, SO A SECOND ANCHOR WAS USED TO COMPLETE THE PROCEDURE. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2025. ADDITIONAL INFORMATION HAS BEEN REQUESTED ON 09/11/2025.

  Patient problems: Insufficient Information

  MAUDE report 23043395 ↗
• MalfunctionSep 9, 2025Break; Break

  ON (B)(6) 2025, AN ARTHREX SUBSIDIARY EMPLOYEE REPORTED VIA EMAIL THAT AN AR-2324BCCT BIOCOMPOSITE SWIVELOCK C, 4.75 MM X 19.1 MM, WITH BLUE FIBERTAPE LOOP EXPERIENCED AN ISSUE DURING INSERTION. THE SURGEON NOTED THAT NO RESISTANCE WAS FELT WHILE INSERTING THE ANCHOR, AND UPON INSPECTION, IT WAS FOUND TO BE BROKEN. AS THERE WAS NO RESISTANCE DURING PLACEMENT, THE CAUSE OF THE BREAKAGE REMAINS UNCLEAR. THE CASE WAS COMPLETED. THIS WAS DISCOVERED DURING A SHOULDER ARTHROSCOPY PROCEDURE ON (B)(6) 2025, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED ON 08/27/2025.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23004294 ↗
• MalfunctionSep 3, 2025Break; Break

  ON 14TH AUGUST 2025, IT WAS REPORTED BY AN ARTHREX'S EMPLOYEE VIA AN EMAIL THAT FOR 1 UNIT OF AR-2324BCCT, SUTURE ANCHOR, BIOCOMPOSITE SWIVELOCK® C VENTED, 4.75 X 19.1 MM, WITH FIBERTAPE® LOOP (BLUE), ITS ANCHOR BROKE DURING INSERTION. THIS WAS DETECTED DURING A ROTATOR CUFF REPAIR SURGERY ON (B)(6) 2025. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY USING ANOTHER NEW AR-2324BCCT. THERE WAS NO PATIENT HARM AND NO SECONDARY PROCEDURE NEEDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22952507 ↗
• MalfunctionAug 22, 2025Positioning Failure; Failure to Advance; Positioning Failure; Failure to Advance

  ON 7/18/2025, AN EMPLOYEE FROM AN ARTHREX SUBSIDIARY REPORTED VIA EMAIL THAT AN ISSUE OCCURRED WITH AN AR-2324BCCT BIOCOMPOSITE SWIVELOCK. THE CORRECT DRILLING AND TAPPING PROCEDURES WERE FOLLOWED. AS THE ANCHOR WAS INSERTED AND TURNED, THE SHAFT OPENED. NO EXCESSIVE FORCE WAS APPLIED. THE ANCHOR WAS REMOVED AND REPOSITIONED. HOWEVER, THE SHAFT HAD BECOME DAMAGED, WHICH IN TURN DAMAGED THE SCREW, RENDERING IT UNUSABLE. THIS WAS DISCOVERED DURING A KNEE ARTHROSCOPY PROCEDURE ON (B)(6) 2025.

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

  MAUDE report 22871944 ↗
• MalfunctionAug 13, 2025Difficult to Insert; Difficult to Insert

  ON 29TH JULY 2025, IT WAS REPORTED BY AN ARTHREX'S EMPLOYEE VIA EMAIL THAT FOR ONE UNIT OF AR-2324BCCT, THERE IS A HARD BODY FAILURE DURING INSERTION. THE ANCHOR WAS TOO HARD TO INSERT PROPERLY. THIS WAS DETECTED DURING A MODIFIED BROSTROM OPERATION ON (B)(6) 2025. THE CASE WAS COMPLETED SUCCESSFULLY BY USING A REPLACEMENT PRODUCT, AR-2324BCC. THERE IS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22792356 ↗
• MalfunctionAug 11, 2025Break; Break

  ON 25TH JULY 2025, IT WAS REPORTED BY A DISTRIBUTOR VIA EMAIL THAT FOR AN AR-2324BCCT, SUTURE ANCHOR, BIOCOMPOSITE SWIVELOCK® C VENTED, 4.75 X 19.1 MM, WITH FIBERTAPE® LOOP (BLUE), THE ANCHOR WAS UNABLE TO SCREW IN COMPLETELY THEN IT WAS FOUND BROKEN. AR-1678-01 AND AR-1678-05 WERE USED TO DRILL THE PILOT HOLE THEN AR-1927CTB WAS USED FOR FINAL TAPPING. ALL FRAGMENTS WERE RETRIEVED. THIS WAS DETECTED DURING USE IN AN ACL RECONSTRUCTION ON (B)(6) 2025. THE SWIVELOCK WAS USED FOR ACL BACK UP FIXATION ON TIBIAL SITE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AS AR-2324PSLC PEEK SWIVELOCK WAS USED TO COMPLETE THE SURGERY.

  Patient problems: Insufficient Information

  MAUDE report 22773448 ↗
• MalfunctionAug 8, 2025Break; Break

  ON 22ND JULY 2025, IT WAS REPORTED BY AN ARTHREX'S EMPLOYEE VIA EMAIL THAT FOR AN AR-2324BCCT, SUTURE ANCHOR, BIOCOMPOSITE SWIVELOCK® C VENTED, 4.75 X 19.1 MM, WITH F IBERTAPE® LOOP (BLUE), ITS ANCHOR BROKE DURING INSERTION. THIS WAS DETECTED DURING A ROTATOR CUFF REPAIR SURGERY ON (B)(6) 2025. THE CASE WAS COMPLETED SUCCESSFULLY BY USING ANOTHER NEW AR-2324BCCT. THERE WAS NO PATIENT HARM, AND NO SECONDARY PROCEDURE NEEDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22749401 ↗
• MalfunctionAug 8, 2025Break; Break

  ON 22ND JULY 2025, IT WAS REPORTED BY AN ARTHREX'S EMPLOYEE VIA EMAIL THAT FOR AN AR-2324BCCT, SUTURE ANCHOR, BIOCOMPOSITE SWIVELOCK® C VENTED, 4.75 X 19.1 MM, WITH F IBERTAPE® LOOP (BLUE), ITS ANCHOR BROKE DURING INSERTION. THIS WAS DETECTED DURING AN ANTERIOR CRUCIATE LIGAMENT REPAIR OF THE KNEE JOINT SURGERY ON (B)(6) 2025. THE CASE WAS COMPLETED SUCCESSFULLY BY USING ANOTHER BRAND PRODUCT. THERE WAS NO PATIENT HARM, AND NO SECONDARY PROCEDURE NEEDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22749305 ↗
• InjuryAug 6, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  ON 07/16/2025, A FACILITY REPRESENTATIVE REPORTED VIA EMAIL THAT ONE OF THEIR PATIENTS DEVELOPED A POST-OPERATIVE INFECTION IN THE LEFT SHOULDER FOLLOWING AN ARTHROSCOPIC PROCEDURE ON (B)(6) 2025. THE FOLLOWING ARTHREX PRODUCTS WERE IMPLANTED DURING THE CASE: (QTY. 2) AR-2324BCCT BIOCOMPOSITE SWIVELOCK C SUTURE ANCHOR. (QTY. 3) AR-2323BCC BIOCOMPOSITE SWIVELOCK C SUTURE ANCHOR. (QTY. 1) AR-2324BCCTT BIOCOMPOSITE SWIVELOCK C SUTURE ANCHOR. (QTY. 1) AR-1680BC BIOCOMPOSITE-TENODESIS SCREW 8 X 12 MM. ABS-3101 BONESYNC FAST-SETTING DRILLABLE CALCIUM PHOSPHATE CEMENT (INJECTION) THE INFECTION WAS IDENTIFIED POST-OPERATIVELY, AND NO ADDITIONAL CLINICAL DETAILS WERE PROVIDED. ADDITIONAL INFORMATION WAS RECEIVED ON 07/23/2025: THE PATIENT INITIALLY UNDERWENT ROTATOR CUFF REPAIR, BICEPS TENODESIS, AND DISTAL CLAVICLE EXCISION ON (B)(6) 2025. APPROXIMATELY TWO WEEKS AFTER SURGERY, SIGNS OF INFECTION EMERGED, INCLUDING PAIN, TENDERNESS, AND PURULENT DRAINAGE. CLINICAL EVALUATION CONFIRMED A LOCALIZED PURULENT SUBCUTANEOUS ABSCESS, WITH NO EVIDENCE OF INTRA-ARTICULAR INVOLVEMENT AND THE ROTATOR CUFF REMAINING INTACT. A CULTURE COLLECTED DURING ASSESSMENT REVEALED A SCANT AMOUNT OF CUTIBACTERIUM

  Patient problems: Unspecified Infection

  MAUDE report 22725965 ↗
• InjuryAug 6, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  ON 07/16/2025, A FACILITY REPRESENTATIVE REPORTED VIA EMAIL THAT ONE OF THEIR PATIENTS DEVELOPED A POST-OPERATIVE INFECTION IN THE LEFT SHOULDER FOLLOWING AN ARTHROSCOPIC PROCEDURE ON (B)(6) 2025. THE FOLLOWING ARTHREX PRODUCTS WERE IMPLANTED DURING THE CASE: (QTY. 2) AR-2324BCCT BIOCOMPOSITE SWIVELOCK C SUTURE ANCHOR. (QTY. 3) AR-2323BCC BIOCOMPOSITE SWIVELOCK C SUTURE ANCHOR. (QTY. 1) AR-2324BCCTT BIOCOMPOSITE SWIVELOCK C SUTURE ANCHOR. (QTY. 1) AR-1680BC BIOCOMPOSITE-TENODESIS SCREW 8 X 12 MM. ABS-3101 BONESYNC FAST-SETTING DRILLABLE CALCIUM PHOSPHATE CEMENT (INJECTION). THE INFECTION WAS IDENTIFIED POST-OPERATIVELY, AND NO ADDITIONAL CLINICAL DETAILS WERE PROVIDED. ADDITIONAL INFORMATION WAS RECEIVED ON 07/23/2025: THE PATIENT INITIALLY UNDERWENT ROTATOR CUFF REPAIR, BICEPS TENODESIS, AND DISTAL CLAVICLE EXCISION ON (B)(6) 2025. APPROXIMATELY TWO WEEKS AFTER SURGERY, SIGNS OF INFECTION EMERGED, INCLUDING PAIN, TENDERNESS, AND PURULENT DRAINAGE. CLINICAL EVALUATION CONFIRMED A LOCALIZED PURULENT SUBCUTANEOUS ABSCESS, WITH NO EVIDENCE OF INTRA-ARTICULAR INVOLVEMENT AND THE ROTATOR CUFF REMAINING INTACT. A CULTURE COLLECTED DURING ASSESSMENT REVEALED A SCANT AMOUNT OF CUTIBACTERIU

  Patient problems: Unspecified Infection

  MAUDE report 22725786 ↗
• MalfunctionJul 24, 2025Break; Break

  ON (B)(6) 2025, IT WAS REPORTED BY A DISTRIBUTOR VIA EMAIL THAT AN AR-2324BCCT, SUTURE ANCHOR, BIOCOMPOSITE SWIVELOCK® C VENTED, 4.75 X 19.1 MM, WITH FIBERTAPE® LOOP (BLUE), WAS USED AS BACKUP FIXATION ON THE TIBIAL SITE OF ACL RECONSTRUCTION CASE. THE 5.5MM TAP WAS USED SEVERAL TIMES TO ENSURE THE HOLE WAS WELL PREPARED FOR SCREW INSERTION. THE BIOCOMPOSITE ANCHOR WAS STILL DAMAGED DURING INSERTION. A PEEK ANCHOR WAS USED AS REPLACEMENT THEN THE FINAL FIXATION WAS COMPLETED WITH 4 LIMBS SUTURES. THIS WAS DETECTED DURING USE IN AN ACL RECONSTRUCTION PROCEDURE ON (B)(6) 2025. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AS PEEK SWIVELOCK AR-2324PSLC USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22588842 ↗
• MalfunctionJun 4, 2025Break; Break

  IT WAS REPORTED THAT DURING A SHOULDER ROTATOR CUFF SURGERY THE SCREW BROKE. THE BROKEN OFF PIECE HAS BEEN 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 22142412 ↗
• MalfunctionMay 14, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ON 04/22/2025, AN ARTHREX SUBSIDIARY EMPLOYEE REPORTED VIA EMAIL THAT THE EYELET TIP ON AN AR-2324BCCT SUTURE ANCHOR HAD FALLEN OUT. THE CASE WAS COMPLETED USING A REPLACEMENT AR-2324BCCT SUTURE ANCHOR. THIS WAS DISCOVERED DURING A ROTATOR CUFF PROCEDURE ON (B)(6) 2025, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22021766 ↗
• MalfunctionMay 2, 2025Break; Break

  ON 22ND APRIL 2025, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT AN AR-2324BCCT, SUTURE ANCHOR, BIOCOMPOSITE SWIVELOCK® C VENTED, 4.75 X 19.1 MM, WITH FIBERTAPE® LOOP (BLUE), ANCHOR BROKE DURING INSERTION. THIS WAS DETECTED DURING A REDUCTION AND FIXATION OF POSTERIOR INTERCONDYLAR SPINE FRACTURES OF THE KNEE JOINT SURGERY ON (B)(6) 2025. NO FRAGMENTS WERE LEFT IN THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING ANOTHER NEW AR-2324BCCT. THERE WAS NO PATIENT HARM AND NO SECONDARY PROCEDURE NEEDED. AR-2324PTB WAS USED TO PREPARE BONE SOCKET.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21952198 ↗