Arthrex® AR-2324BCCRecalls & reported problems
Arthrex, Inc. · BIO-COMP SWVLK C, CLD 4.75X19.1MM · Class 2 · Implant
Quick summary
This Arthrex BioComposite SwiveLock anchor has 248 reports on file, with no deaths and 36 injuries. Many describe the anchor or its screw breaking during insertion or fixation, some involving broken fragments, and others describe anchors that could not be fixed in bone. No recalls name this device, and reports fell to 35 in the latest year from 71 in the year before.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 254
- Deaths reported
- 0
- Injuries reported
- 36
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 254 adverse event reports that list this exact device (DI 00888867026827), received between Aug 23, 2016 and Sep 29, 2026 — classified as 36 injuries, 218 malfunctions.
The most frequently reported specific device problem is “Break” (162 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.
Reports received per month
Most reported problems
Device problems
- Break162
- Device Dislodged or Dislocated23
- Failure to Advance11
- Detachment of Device or Device Component8
- Patient-Device Incompatibility8
- Material Deformation7
- Physical Resistance/Sticking7
- Defective Device5
Patient problems
- No Clinical Signs, Symptoms or Conditions166
- Insufficient Information54
- Foreign Body In Patient11
- Failure of Implant10
- Pain9
- Swelling5
- Hypersensitivity/Allergic reaction3
- No Known Impact Or Consequence To Patient3
Recent adverse event reports
The 25 most recent of 254 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50933667 ↗MalfunctionSep 25, 2026Break
On (b)(6) 2026, it was reported by an Arthrex's employee via an Email that for 1 unit of AR-2324BCC, Suture Anchor, BioComposite SwiveLock® C, 4.75 mm x 19.1 mm, Closed Eyelet, its anchor broke during insertion.This was detected during a rotator cuff repair surgery on (b)(6) 2026. The procedure was completed successfully by using another new AR-2324BCC. There were no patient harm and no secondary procedure needed.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50898395 ↗MalfunctionSep 17, 2026Device Dislodged or Dislocated
On 3rd September 2026, it was reported by an Arthrex's employee via an Email that for 1 unit of AR-2324BCC, Suture Anchor, BioComposite SwiveLock® C, 4.75 mm x 19.1 mm, Closed Eyelet, when tightening the suture, the anchor was pulled out.This was detected during a rotator cuff repair surgery on (b)(6) 2026. The procedure was completed successfully by using another new AR-2324BCC. There were no patient harm and no secondary procedure needed.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50805065 ↗MalfunctionSep 17, 2026Defective Device
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50804960 ↗MalfunctionSep 17, 2026Device Dislodged or Dislocated
On 3rd September 2026, it was reported by an Arthrex's employee via an Email that for 2 units of AR-2324BCC, Suture Anchor, BioComposite SwiveLock® C, 4.75 mm x 19.1 mm, Closed Eyelet:When tightening the suture on the first implant, the anchor was pulled out. Another AR-2324BCC was changed to but the anchor was damaged during insertion.This was detected during a rotator cuff repair surgery on (b)(6) 2026. The procedure was completed successfully by using a third AR-2324BCC. There were no patient harm and no secondary procedure needed.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50804741 ↗MalfunctionSep 17, 2026Break
On 3rd September 2026, it was reported by an Arthrex's employee via an Email that for 1 unit of AR-2324BCC, Suture Anchor, BioComposite SwiveLock® C, 4.75 mm x 19.1 mm, Closed Eyelet, its anchor broke during insertion. This was detected during a rotator cuff repair surgery on (b)(6) 2026. The procedure was completed successfully by using another new AR-2324BCC. There were no patient harm and no secondary procedure needed.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50802530 ↗MalfunctionAug 3, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50113630 ↗MalfunctionJul 31, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50098323 ↗MalfunctionJul 31, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50098113 ↗MalfunctionJul 29, 2026Break
It was reported that during an posterior cruciate ligament reconstruction with internal brace the screw broke in half when the surgeon removed the swivelock during fixation of the internal brace in the tibia. All fragments were retrieved. 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 50073090 ↗MalfunctionJun 5, 2026Positioning Failure
IT WAS REPORTED THAT DURING A QUADRICEPS TENDON REFIXATION SURGERY 4 DEVICES COULD NOT BE FIXATED IN THE BONE. 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 25406815 ↗MalfunctionApr 1, 2026Break
ON 12TH MARCH 2026, IT WAS REPORTED BY AN ARTHREX'S EMPLOYEE VIA AN EMAIL THAT FOR 1 UNIT OF AR-2324BCC, SUTURE ANCHOR, BIOCOMPOSITE SWIVELOCK® C, 4.75 MM X 19.1 MM, CLOSED EYELET, ITS ANCHOR BROKE DURING INSERTION. THIS WAS DETECTED DURING A ROTATOR CUFF REPAIR SURGERY ON (B)(6) 2026. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY USING ANOTHER NEW AR-2324BCC. THERE WERE NO PATIENT HARM AND NO SECONDARY PROCEDURE NEEDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24752899 ↗MalfunctionMar 30, 2026Break
ON 10TH MARCH 2026, IT WAS REPORTED BY AN ARTHREX'S EMPLOYEE VIA AN EMAIL THAT FOR 1 UNIT OF AR-2324BCC, SUTURE ANCHOR, BIOCOMPOSITE SWIVELOCK® C, 4.75 MM X 19.1 MM, CLOSED EYELET, 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 AR2324BCC. THERE WERE NO PATIENT HARM AND NO SECONDARY PROCEDURE NEEDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24715272 ↗MalfunctionMar 30, 2026Break
ON 10TH MARCH 2026, IT WAS REPORTED BY AN ARTHREX'S EMPLOYEE VIA AN EMAIL THAT FOR 1 UNIT OF AR-2324BCC, SUTURE ANCHOR, BIOCOMPOSITE SWIVELOCK® C, 4.75 MM X 19.1 MM, CLOSED EYELET, 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-2324BCC. THERE WERE NO PATIENT HARM AND NO SECONDARY PROCEDURE NEEDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24714443 ↗MalfunctionMar 26, 2026Break
ON (B)(6) 2026, IT WAS REPORTED BY AN ARTHREX'S EMPLOYEE VIA AN EMAIL THAT FOR 1 UNIT OF AR-2324BCC, SUTURE ANCHOR, BIOCOMPOSITE SWIVELOCK® C, 4.75 MM X 19.1 MM, CLOSED EYELET, ITS ANCHOR BROKE DURING INSERTION. THIS WAS DETECTED DURING AN ANKLE JOINT INSTABILITY SURGERY ON (B)(6) 2025. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY USING ANOTHER NEW AR-2324BCC. THERE WERE NO PATIENT HARM AND NO SECONDARY PROCEDURE NEEDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24698348 ↗MalfunctionMar 25, 2026Physical Resistance/Sticking
IT WAS REPORTED THAT DURING A SURGERY THE ANCHOR WAS IMPOSSIBLE TO SEPARATE FROM THE DRIVER AFTER INSERTION. THE SURGEONS TRIED TWO MORE TIMES WITHOUT SUCCESS AND THEN OPENED A NEW DEVICE WHICH WORKED FINE. 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 24688774 ↗MalfunctionMar 25, 2026Positioning Failure
ON 5TH MARCH 2026, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT FOR AN AR-2324BCC, SUTURE ANCHOR, BIOCOMPOSITE SWIVELOCK® C, 4.75 MM X 19.1 MM, CLOSED EYELET, THE ANCHOR COULD NOT BE SET SUCCESSFULLY. THIS WAS DETECTED DURING A ROTATOR CUFF REPAIR SURGERY ON (B)(6) 2026. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AS ANOTHER NEW AR-2324BCC WAS USED. AR-1927PB AND AR-2324PTB WERE USED TO PREPARE THE BONE SOCKET. THE BONE QUALITY OF PATIENT WAS SOFT AND NO FRAGMENTS WERE FOUND. 13TH MARCH 2026 - THE COMPLAINT INITIATOR REPLIED THAT THE ANCHOR COULD NOT BE FULLY IMPLANTED, SO THE SURGEON NEEDED TO REPLACE A NEW ANCHOR TO COMPLETE THE PROCEDURE. HE CONFIRMED THAT THE ANCHOR WAS DEPLOYED SUCCESSFULLY, BUT IMPLANT WOULD NOT SEAT.
Patient problems: Insufficient Information
MAUDE report 24688393 ↗MalfunctionMar 25, 2026Material Deformation
ON 5TH MARCH 2026, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT FOR AN AR-2324BCC, SUTURE ANCHOR, BIOCOMPOSITE SWIVELOCK® C, 4.75 MM X 19.1 MM, CLOSED EYELET; THE ANCHOR WAS DEFORMED DURING INSERTION. THIS WAS DETECTED DURING A ROTATOR CUFF REPAIR SURGERY ON (B)(6) 2026. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AS ANOTHER NEW AR-2324BCC WAS USED. AR-1927PB AND AR-2324PTB WERE USED TO PREPARE BONE SOCKET. THE BONE QUALITY OF PATIENT WAS HARD, AND NO FRAGMENTS WERE LEFT IN THE PATIENT.
Patient problems: Insufficient Information
MAUDE report 24687915 ↗MalfunctionMar 25, 2026Break
ON 5TH MARCH 2026, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT FOR AN AR-2324BCC, SUTURE ANCHOR, BIOCOMPOSITE SWIVELOCK® C, 4.75 MM X 19.1 MM, CLOSED EYELET, THE ANCHOR BROKE DURING INSERTION. THIS WAS DETECTED DURING A ROTATOR CUFF REPAIR SURGERY ON (B)(6) 2026. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AS ANOTHER NEW AR-2324BCC WAS USED. AR-1927PB AND AR-2324PTB WERE USED TO PREPARE BONE SOCKET AND THE BONE QUALITY OF PATIENT WAS HARD. THERE WERE NO FRAGMENTS LEFT IN THE PATIENT.
Patient problems: Insufficient Information
MAUDE report 24687516 ↗MalfunctionMar 23, 2026Device Dislodged or Dislocated
ON 4TH MAR 2026, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT AN AR-13995N CORPION-MULTIFIRE NEEDLE BROKE AFTER THE SUTURE WAS PASSED THROUGH. IN ADDITION, THE BIO-COMP SWVLK C, CLD 4.75 X 19.1 MM, BATCH 15412798, WAS OBSERVED TO HAVE SWIVELOCK ANCHOR PULLED OUT. THIS WAS DETECTED DURING THE PROCEDURE ON (B)(6) 2026 AND WAS POSSIBLY DUE TO THE PATIENT HAVING SOFT BONE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24661375 ↗MalfunctionMar 23, 2026Break
ON 3RD MARCH 2026, IT WAS REPORTED BY AN ARTHREX'S EMPLOYEE VIA AN EMAIL THAT FOR 1 UNIT OF AR-2324BCC, SUTURE ANCHOR, BIOCOMPOSITE SWIVELOCK® C, 4.75 MM X 19.1 MM, CLOSED EYELET, 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-2324BCC. THERE WERE NO PATIENT HARM AND NO SECONDARY PROCEDURE NEEDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24660999 ↗MalfunctionMar 23, 2026Break
ON 3RD MARCH 2026, IT WAS REPORTED BY AN ARTHREX'S EMPLOYEE VIA AN EMAIL THAT FOR 2 UNITS OF AR-2324BCC, SUTURE ANCHOR, BIOCOMPOSITE SWIVELOCK® C, 4.75 MM X 19.1 MM, CLOSED EYELET, BOTH 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-2324BCC. THERE WERE NO PATIENT HARM AND NO SECONDARY PROCEDURE NEEDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24660845 ↗MalfunctionMar 23, 2026Break
ON 3RD MARCH 2026, IT WAS REPORTED BY AN ARTHREX'S EMPLOYEE VIA AN EMAIL THAT FOR 2 UNITS OF AR-2324BCC, SUTURE ANCHOR, BIOCOMPOSITE SWIVELOCK® C, 4.75 MM X 19.1 MM, CLOSED EYELET, BOTH 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-2324BCC. THERE WERE NO PATIENT HARM AND NO SECONDARY PROCEDURE NEEDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24660774 ↗MalfunctionMar 18, 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-2324BCC, SUTURE ANCHOR, BIOCOMPOSITE SWIVELOCK® C, 4.75 MM X 19.1 MM, CLOSED EYELET, ITS ANCHOR PULLED OUT 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-2324BCC. THERE WERE NO PATIENT HARM AND NO SECONDARY PROCEDURE NEEDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24628464 ↗MalfunctionMar 3, 2026Break
ON 11-FEB-2026, A DISTRIBUTOR REPORTED VIA EMAIL THAT AN AR-2324BCC BIOCOMPOSITE SWIVELOCK C ANCHOR BROKE DURING INSERTION OF THE SWIVELOCK. THE ISSUE WAS IDENTIFIED INTRAOPERATIVELY ON (B)(6) 2026, AND NO PATIENT HARM WAS REPORTED. ADDITIONAL INFORMATION WAS RECEIVED ON 19-FEB-2026: DURING A SUBSCAPULARIS REPAIR PROCEDURE, THE THREADS OF AN AR-2324BCC BIOCOMPOSITE SWIVELOCK C ANCHOR STRIPPED UPON INSERTION. ALL ASSOCIATED FRAGMENTS WERE RETRIEVED FROM THE PATIENT. THE SURGEON REPLACED THE DEVICE WITH AN AR-2324BCC IMPLANT TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED DELAY IN THE CASE OR ADDITIONAL ANESTHESIA TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24499655 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.