Arthrex® AR-2324BCCTTRecalls & reported problems

Summary

The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 00888867026858), received between Nov 8, 2016 and Sep 22, 2026 — classified as 7 injuries, 24 malfunctions.

The most frequently reported specific device problem is “Break” (11 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 31 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 22, 2026Device Dislodged or Dislocated; Material Deformation

  On 7 Sep 2026, a distributor reported via email that one unit of AR-2324BCCTT Batch 15503537 experienced a deployment issue. The issue was identified during an ATFL repair procedure performed on 11 May 2026. During the procedure, the SwiveLock anchor pulled out from the talus site while the plastic handle was being removed. Following removal, the anchor screw was observed to be deformed and could not be reloaded to complete the repair. An additional SwiveLock anchor was subsequently used to successfully complete the surgery. AR-1678-01, AR-1678-02, and AR-2324PTB were used for hole preparation. No device fragments remained in the patient.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50856603 ↗
• MalfunctionSep 21, 2026Material Deformation

  On 7th September 2026, it was reported by a Distributor via an Email that for 1 unit of AR-2324BCCTT, Suture Anchor, BioComposite SwiveLock® C Vented 4.75 x 19.1 mm, with TigerTape® Loop Suture (White/Black), its anchor was deformed.This was detected during a RCT repair procedure on (b)(6) 2026. The procedure was completed successfully by using another SwiveLock. There was no patient harm.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50845167 ↗
• MalfunctionSep 21, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50842594 ↗
• MalfunctionSep 21, 2026Material Deformation

  On 7th September 2026, it was reported by a Distributor via an Email that 1 unit of AR-2324BCCTT, Suture Anchor, BioComposite SwiveLock® C Vented 4.75 x 19.1 mm, with TigerTape® Loop Suture (White/Black), was deformed.This was detected during a RCT repair on (b)(6) 2026. The procedure was completed successfully by using additional AR-2324BCCTT. There was no patient harm.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50842090 ↗
• MalfunctionJan 21, 2026Material Deformation

  ON 6 JANUARY 2026, A DISTRIBUTOR REPORTED VIA EMAIL THAT A SWIVELOCK SCREW BECAME DEFORMED DURING INSERTION INTO THE HUMERUS IN AN ELBOW DISLOCATION CASE. INSTRUMENTS AR-1678-01, AR-1678-02, AR-2324PTB, AND AR-1927CTB WERE USED FOR THE HOLE PREPARATION. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING AN ADDITIONAL SWIVELOCK, WITH NO FRAGMENTS RETAINED IN THE PATIENT AND NO HARM REPORTED. A BONE DENSITY ASSESSMENT WAS NOT PERFORMED FOR THIS CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24129422 ↗
• MalfunctionJan 12, 2026Material Deformation

  ON 29TH DECEMBER 2025, IT WAS REPORTED BY A DISTRIBUTOR VIA EMAIL THAT FOR AN AR-2324BCCTT, SUTURE ANCHOR, BIOCOMPOSITE SWIVELOCK® C VENTED 4.75 X 19.1 MM, WITH TIGERTAPE® LOOP SUTURE (WHITE/BLACK), THE SWIVELOCK SCREW WAS DEFORMED DURING INSERTION INTO DISTAL HUMERUS. THIS WAS DETECTED DURING USE IN A LUCL REPAIR PROCEDURE ON (B)(6) 2025. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AS AN ADDITIONAL SWIVELOCK WAS USED. AR-1678-01, AR-1678-02, AR-2324PTB WERE USED FOR HOLE PREPARATION. BONE DENSITY TEST WAS NOT PERFORMED. NO FRAGMENT WAS LEFT INSIDE THE PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 24041055 ↗
• MalfunctionJan 2, 2026Break

  ON 15TH DECEMBER 2025, IT WAS REPORTED BY A DISTRIBUTOR VIA EMAIL THAT FOR AN AR-2324BCCTT, SUTURE ANCHOR, BIOCOMPOSITE SWIVELOCK® C VENTED 4.75 X 19.1 MM, WITH TIGERTAPE® LOOP SUTURE (WHITE/BLACK), THE SWIVELOCK SCREW WAS BROKEN DURING INSERTION INTO HUMERUS. THIS WAS DETECTED DURING USE IN AN ELBOW LUCL PROCEDURE ON (B)(6) 2025. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AS AN ADDITIONAL SWIVELOCK WAS USED. AR-1678-01, AR-1678-02, AR-2324PTB WERE USED FOR HOLE PREPARATION. BONE DENSITY TEST WAS NOT PERFORMED. NO FRAGMENT WAS LEFT INSIDE THE PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 23946187 ↗
• MalfunctionJan 2, 2026Break

  ON 15TH DECEMBER 2025, IT WAS REPORTED BY A DISTRIBUTOR VIA EMAIL THAT FOR AN AR-2324BCCTT, SUTURE ANCHOR, BIOCOMPOSITE SWIVELOCK® C VENTED 4.75 X 19.1 MM, WITH TIGERTAPE® LOOP SUTURE (WHITE/BLACK), THE SWIVELOCK EYELET WAS BROKEN DURING INSERTION. THIS WAS DETECTED DURING USE IN AN ARTHROSCOPIC RCT REPAIR PROCEDURE ON (B)(6) 2025. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AS AN ADDITIONAL SWIVELOCK WAS USED. AR-1927PB WAS USED TO PUNCH THE INSERTION HOLE. BONE DENSITY TEST WAS NOT PERFORMED. NO FRAGMENT WAS LEFT INSIDE THE PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 23945996 ↗
• MalfunctionDec 24, 2025Break; Break

  ON 4TH DECEMBER 2025, IT WAS REPORTED BY A DISTRIBUTOR VIA EMAIL THAT FOR AN AR-2324BCCTT, SUTURE ANCHOR, BIOCOMPOSITE SWIVELOCK® C VENTED 4.75 X 19.1 MM, WITH TIGERTAPE® LOOP SUTURE (WHITE/BLACK), THE SWIVELOCK EYELET WAS BROKEN DURING INSERTION INTO HUMERAL HEAD. AR-1927PB WAS USED TO PUNCH THE HOLE. THIS WAS DETECTED DURING USE IN A RCT REPAIR ON (B)(6) 2025. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AS AN ADDITIONAL SWIVELOCK WAS USED. NO FRAGMENT WAS LEFT INSIDE THE PATIENT. BONE DENSITY TEST WAS NOT PERFORMED.

  Patient problems: Insufficient Information

  MAUDE report 23888019 ↗
• MalfunctionSep 9, 2025Material Twisted/Bent; Material Twisted/Bent

  ON 20TH AUGUST 2025, IT WAS REPORTED BY A DISTRIBUTOR VIA EMAIL THAT FOR AN AR-2324BCCTT, SUTURE ANCHOR, BIOCOMPOSITE SWIVELOCK® C VENTED 4.75 X 19.1 MM, WITH TIG ERTAPE® LOOP SUTURE (WHITE/BLACK), THE SWIVELOCK EYELET WAS DEFORMED AFTER INSERTING TO THE HUMERAL HEAD. THIS WAS DETECTED DURING USE IN A RCT REPAIR PROCEDURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY USING AN ADDITIONAL SWIVELOCK. AR-1927PB WAS USED AS PUNCH. BONE DENSITY TEST WAS NOT PERFORMED. NO FRAGMENT WAS LEFT INSIDE THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23005669 ↗
• MalfunctionAug 20, 2025Failure to Advance; Failure to Advance

  ON 5TH AUGUST 2025, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT FOR AN AR-2324BCCTT, SUTURE ANCHOR, BIOCOMPOSITE SWIVELOCK® C VENTED 4.75 X 19.1 MM, WITH TIGERTAPE® LOOP SUTURE (WHITE/BLACK), THE SWIVELOCK ANCHOR EYELET WAS DAMAGED WHILE INSERTION ON TIBIAL SITE DURING ACL RECONSTRUCTION BACKUP FIXATION. THIS WAS DETECTED DURING USE IN AN ACL RECONSTRUCTION ON (B)(6) 2025. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AS AN ADDITIONAL SWIVELOCK WAS USED. AR-1678-02 WAS USED FOR DRILLING, AR-2324PTB WAS USED FOR ANCHOR HOLE PREPARATION AND TAPPING FOR 3 TIMES. NO FRAGMENT WAS LEFT INSIDE THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22851607 ↗
• MalfunctionAug 8, 2025Failure to Advance; Failure to Advance

  ON 22ND JULY 2025, IT WAS REPORTED BY A DISTRIBUTOR VIA EMAIL THAT FOR AN AR-2324BCCTT, SUTURE ANCHOR, BIOCOMPOSITE SWIVELOCK® C VENTED 4.75 X 19.1 MM, WITH TIG ERTAPE® LOOP SUTURE (WHITE/BLACK), THE SWIVELOCK SCREW WAS UNABLE TO BE INSERTED INTO TALUS AFTER REPEATEDLY TAPPING STEP IN DELTOID RECONSTRUCTION CASE. THE SCREW THREAD WAS DAMAGED AND COULD NOT BE IMPLANTED. THIS WAS DETECTED DURING USE IN AN ATFL & DELTOID RECONSTRUCTION PROCEDURE ON (B)(6) 2025. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AS AN ADDITIONAL SWIVELOCK WAS USED.

  Patient problems: Insufficient Information

  MAUDE report 22749906 ↗
• MalfunctionAug 8, 2025Failure to Advance; Failure to Advance

  ON 22ND JULY 2025, IT WAS REPORTED BY A DISTRIBUTOR VIA EMAIL THAT FOR AN AR-2324BCCTT, SUTURE ANCHOR, BIOCOMPOSITE SWIVELOCK® C VENTED 4.75 X 19.1 MM, WITH TIG ERTAPE® LOOP SUTURE (WHITE/BLACK), THE SWIVELOCK SCREW WAS UNABLE TO BE INSERTED INTO THE TIBIA AFTER REPEATEDLY TAPPING STEP IN ACL RECONSTRUCTION BACK UP FIXATION CASE. THE SCREW THREAD WAS DAMAGED AND COULD NOT BE IMPLANTED. THIS WAS DETECTED DURING USE IN AN ACL RECONSTRUCTION PROCEDURE ON (B)(6) 2025. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AS AN ADDITIONAL SWIVELOCK WAS USED.

  Patient problems: Insufficient Information

  MAUDE report 22749705 ↗
• InjuryAug 6, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  ON (B)(6) 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 CUTIBACTERI

  Patient problems: Unspecified Infection

  MAUDE report 22725784 ↗
• MalfunctionJul 18, 2025Break; Break

  ON 06/24/2025, IT WAS REPORTED BY A DISTRIBUTOR VIA (B)(4) THAT AN AR-2324BCCTT SUTURE ANCHOR SUTURE BROKE. THIS OCCURRED DURING USE. THERE WAS NO ADDITIONAL INFORMATION PROVIDED, AND ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22541827 ↗
• MalfunctionJul 17, 2025Break; Break

  ON 06/24/2025, IT WAS REPORTED BY A DISTRIBUTOR VIA SEMS-(B)(4) THAT AN AR-2324BCCTT SUTURE ANCHOR BROKE. THIS OCCURRED DURING USE. THERE WAS NO ADDITIONAL INFORMATION PROVIDED, AND ADDITIONAL INFORMATION HAS BEEN REQUESTED.

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

  MAUDE report 22535446 ↗
• MalfunctionMay 28, 2025Break; Break

  ON 9TH MAY 2025, IT WAS REPORTED BY A DISTRIBUTOR VIA EMAIL THAT AN AR-2324BCCTT, SUTURE ANCHOR, BIOCOMPOSITE SWIVELOCK® C VENTED 4.75 X 19.1 MM, WITH TIGERTAPE® LOOP SUTURE (WHITE/BLACK), COULD NOT BE SCREWED INTO THE CALCANEUS SUCCESSFULLY. THIS WAS DETECTED DURING USE IN AN ACHILLES REPAIR PROCEDURE ON (B)(6) 2025. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING ANOTHER SWIVELOCK. 19 MAY 2025 - THE DISTRIBUTOR REPLIED THAT THE DRIVER TIP WAS BROKEN SO IT COULD NOT SWIVEL SCREW INTO THE BONE EVEN THOUGH THE SURGEON HAD ALREADY TAPPED THE TARGET SPOT SEVERAL TIMES. THE MAIN DAMAGE WAS ON THE DRIVER TIP INSTEAD OF THE SCREW ITSELF, BUT THIS CAUSED THE SCREW TO NOT BE INSERTED INTO THE BONE. THE SCREW WAS NOT ABLE TO GO IN ANYMORE.

  Patient problems: Insufficient Information

  MAUDE report 22094835 ↗
• MalfunctionJun 24, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  ON 5/30/2024, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA EMAIL THAT AN AR-2324BCCTT BIOCOMPOSITE SWIVELOCK ANCHOR WAS DIFFICULT TO IMPLANT, WHEN THE SCREWDRIVER WAS TURNED IT WAS HARD. THE CASE WAS COMPLETED USING A NEW AR-2324BCCTT BIOCOMPOSITE SWIVELOCK. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2024.

  Patient problems: Insufficient Information

  MAUDE report 19601832 ↗
• MalfunctionMay 14, 2024Unintended Movement; Unintended Movement

  ON 6/29/2022, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT AN AR-2324BCCTT BIOCOMPOSITE SWIVELOCK ANCHOR PULLED OUT OF IMPLANTATION SITE. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2022. A NEW ON WAS USED AN CASE WAS COMPLETED WITHOUT FURTHER ISSUES. ADDITIONAL INFORMATION RECEIVED ON 6/30/2022: THIS WAS DISCOVERED DURING AN RCR PROCEDURE AND COMPLETED USING A PRODUCT FROM ANOTHER MANUFACTURER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19310968 ↗
• MalfunctionMar 11, 2024Break; Break

  ON 2/12/2024, IT WAS REPORTED BY A DISTRIBUTOR VIA (B)(4) THAT AN AR-2324BCCTT BIOCOMPOSITE SWIVELOCK SUTURE ANCHOR EYELET BROKE. THIS WAS DISCOVERED DURING INSPECTION, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION RECEIVED ON 2/28/2024: THIS WAS DISCOVERED DURING A ROTATOR CUFF REPAIR PROCEDURE (B)(6) 2024. THE PEEK EYELET BROKE INSIDE THE PATIENT'S CAVITY AND ALL PIECES WERE RETRIEVED FROM THE PATIENT. THERE WAS NO CASE DELAY AND NO ADVERSE EFFECTS ON THE PATIENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18873496 ↗
• MalfunctionNov 9, 2023Break; Break

  ON 10/20/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-2324BCCTT BIOCOMPOSITE SWIVELOCK C ANCHOR BROKE DURING INSERTION. THIS WAS DISCOVERED DURING AN RCR PROCEDURE ON 10/20/2023. THE CASE WAS COMPLETED USING ANOTHER ANCHOR. ADDITIONAL INFORMATION RECEIVED ON 10/20/2023: ALL THE BROKEN FRAGMENTS WERE RETRIEVED FROM INSIDE THE PATIENT, AND THE CASE WAS COMPLETED USING ANOTHER AR-2324BCCTT BIOCOMPOSITE SWIVELOCK C. THE CASE WAS NOT DELAYED, AND NO ADDITIONAL ANESTHESIA WAS NEEDED. THE PATIENT DID NOT SUFFER ANY NEGATIVE EFFECTS OR HARM DUE TO ANCHOR BREAKAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18103924 ↗
• MalfunctionNov 2, 2023Break; Break

  ON (B)(6) 2023, IT WAS REPORTED BY A DISTRIBUTOR VIA (B)(4) THAT AN (B)(6) BIOCOMPOSITE SWIVELOCK HAD A BROKEN ANCHOR. THIS WAS DISCOVERED DURING AN UNSPECIFIED PROCEDURE ON (B)(6) 2023.

  Patient problems: Insufficient Information

  MAUDE report 18057844 ↗
• MalfunctionAug 25, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON 7/31/2023, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT AN AR-2324BCCTT BIOCOMPOSITE SWIVELOCK ANCHOR WAS PULLED OUT FROM THE PATIENT'S BODY DURING AN MCL REPAIR SURGERY ON (B)(6) 2023. NO ADDITIONAL INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 17624434 ↗
• MalfunctionAug 25, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON (B)(6), IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT AN AR-2324BCCTT AND AR-2323BCC BIOCOMPOSITE SWIVELOCK ANCHOR WAS PULLED OUT FROM THE PATIENT'S BODY DURING AN MCL REPAIR SURGERY ON (B)(6) 2023. NO ADDITIONAL INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 17623847 ↗
• MalfunctionJul 6, 2023Break; Break

  ON(B)(6) 2023, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT AN AR-2324BCCTT BIOCOMPOSITE SWIVELOCK ANCHOR BROKE DURING INSERTION AND THE SUTURES DROPPED OFF. THE CASE WAS COMPLETED USING ANOTHER AR-2324BCCTT BIOCOMPOSITE SWIVELOCK. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2023. ADDITIONAL INFORMATION REQUESTED. ADDITIONAL INFORMATION PROVIDED (B)(6) 2023: THE PROCEDURE PERFORMED WAS A ROTATOR CUFF. THE SUTURE LOOSEN AND THEN CAME APART. ALL BROKEN FRAGMENTS WERE REMOVED AND THE CASE WAS COMPLETED USING ANOTHER AR-2324BCCTT BIOCOMPOSITE SWIVELOCK.

  Patient problems: Insufficient Information

  MAUDE report 17269295 ↗