Arthrex® AR-2324BCC-1Recalls & reported problems

Summary

The FDA's MAUDE database contains 57 adverse event reports that list this exact device (DI 00888867097988), received between Jan 31, 2018 and Sep 11, 2026 — classified as 3 injuries, 54 malfunctions.

The most frequently reported specific device problem is “Break” (34 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 25 most recent of 57 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 11, 2026Material Split, Cut or Torn

  It was reported that during the surgery, the anchor was torn out. 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 50732793 ↗
• MalfunctionAug 28, 2026Break

  It was reported that during a surgery the anchor broke. 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 18 August 2026:Further information was received through a user report submitted to the French competent authority (ANSM). It was reported that the anchor not only fractured during insertion but also became disengaged during subsequent testing. As a result, the surgeon used two additional anchors of a larger size to complete the procedure. The incident led to a prolongation of the surgical procedure.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50496385 ↗
• MalfunctionApr 9, 2026Break

  IT WAS REPORTED THAT DURING A SHOULDER SURGERY WHEN THE SURGEON TRIED TO SCREW IN THE ANCHOR, IT BROKE. ALL FRAGMENTS 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 24832002 ↗
• MalfunctionMar 30, 2026Break

  IT WAS REPORTED THAT DURING A SHOULDER SURGERY THE EYELET BROKE. ALL BROKEN 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 24712705 ↗
• MalfunctionMar 9, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING THE ROTATOR CUFF SURGERY, THE ANCHOR WAS PULLED OUT. 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 24543751 ↗
• MalfunctionFeb 18, 2026Break

  ON (B)(6) 2026, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT FOR AN AR-2324BCC-1, SUTURE ANCHOR, BIOCOMPOSITE SWIVELOCK® C, 4.75 MM X 19.1 MM, CLOSED EYELET, THE 4.75 SWIVELOCK ANCHOR BROKE DURING IMPACTION. THIS WAS DETECTED DURING AN UNSPECIFIED PROCEDURE ON (B)(6) 2026. (B)(6) 2026 - THE COMPLAINT INITIATOR REPLIED THAT THIS WAS DETECTED DURING A PROXIMAL BICEPS REPAIR PROCEDURE ON (B)(6) 2026. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AS ANOTHER AR-2324BCC WAS OPENED.

  Patient problems: Insufficient Information

  MAUDE report 24379846 ↗
• MalfunctionFeb 5, 2026Break

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR SURGERY THE ANCHOR BROKE DURING INSERTION. 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 24272156 ↗
• MalfunctionOct 30, 2025Break; Break

  ON (B)(6) 2025, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT FOR AN AR-2324BCC-1, SUTURE ANCHOR, BIOCOMPOSITE SWIVELOCK® C, 4.75 MM X 19.1 MM, CLOSED EYELET, THE FIRST PITCH ON THREAD OF SWIVELOCK DID NOT ENGAGE AND SNAPPED WHEN INSERTING INTO TIBIA. THIS WAS DETECTED DURING USE IN AN ACL WITH INTERNAL BRACE PROCEDURE ON (B)(6) 2025. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AS ANOTHER ANCHOR WAS USED. THE CORRECT DRILL AND TAP WERE USED AND THE BONE QUALITY WAS EXPECTED FOR PATIENT AGE.

  Patient problems: Insufficient Information

  MAUDE report 23427993 ↗
• MalfunctionSep 9, 2025Break; Break

  IT WAS REPORTED THAT DURING AN INNER LIGAMENT REPAIR SURGERY OF THE RIGHT KNEE JOINT THE TIP OF THE ANCHOR BROKE OFF WHEN IT WAS INSERTED INTO THE CANAL. ALL FRAGMENTS 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 23009878 ↗
• MalfunctionAug 7, 2025Break; Break

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR SURGERY THE ANCHOR BROKE. ALL FRAGMENTS WERE REMOVED 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 22737582 ↗
• MalfunctionJun 27, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ELLISON SURGERY THE EYELET BROKE OFF WHEN THE SUTURE WAS PULLED THROUGH. THE BROKEN PIECE WAS 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 22344948 ↗
• MalfunctionJun 17, 2025Positioning Failure; Damaged Thread; Positioning Failure; Damaged Thread

  IT WAS REPORTED THAT DURING A COLLATERAL LIGAMENT REPAIR SURGERY THE IMPLANT THREAD DID NOT WORK, IT DID NOT PUSH THE SCREW ALL THE WAY DOWN INTO THE HOLE. 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 22236611 ↗
• MalfunctionMar 21, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR SURGERY THE ANCHOR DID NOT HOLD DESPITE CORRECT APPLICATION. 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 21664456 ↗
• MalfunctionMar 17, 2025Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC SURGERY THE IMPLANT DID NOT ANCHOR. 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 21620647 ↗
• MalfunctionMar 17, 2025Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT DURING A KNEE ARTHROSCOPY THE IMPLANT DID NOT ANCHOR. 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 21620486 ↗
• MalfunctionFeb 12, 2025Break; Break

  ON 03 FEBRUARY 2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-2324BCC-1 BIO-COMP SWVLK C, CLD 4.75X19.1MM WAS REPORTED TO HAVE FAILED DURING USE. THIS OCCURRED ON (B)(6) 2025 IN (B)(6) CENTRE DURING A ROTATOR CUFF REPAIR. IT WAS REPORTED THAT CUSTOMER WAS INSERTING THE IMPLANT INTO A MEDIAL ROW ROTATOR CUFF REPAIR WHEN THE INSERTER DISENGAGED PREMATURELY. LEAVING THE EYELET IN THE PRE-MADE HOLE, BUT THE RETENTION SUTURE REMAINING IN THE INSERTION HANDLE. UPON CLOSER INSPECTION, THE EYELET COMPONENT HAD SNAPPED WHERE IT MET THE RETENTION SUTURE. THE EYELET WAS RETRIEVED AND DISCARDED ALONG WITH THE FAULTY INSERTER AND ANCHOR. A NEW ONE WAS INSERTED WITHOUT ISSUE. THE CASE WAS COMPLETED SUCCESSFULLY USING A NEW ANCHOR. THERE WAS CASE INVOLVEMENT.

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

  MAUDE report 21363834 ↗
• MalfunctionJan 30, 2025Break; Break

  IT WAS REPORTED THAT DURING A MENISCUS REPAIR SURGERY THE TIP WAS BROKEN. 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 21273478 ↗
• MalfunctionDec 27, 2024Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT DURING A ROTATOR CUFF SURGERY THE ANCHOR GOT LOOSE INSIDE JOINT AND COULD NOT HOLD. 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 21026736 ↗
• MalfunctionDec 27, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING A KNEE SURGERY THE SCREW JAMMED AND IT WAS IMPOSSIBLE TO INSTALL. 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 21026201 ↗
• MalfunctionDec 10, 2024Break; Break

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR SURGERY THE DEVICE BROKE WHILE BEING SCREWED INTO A PRE-DRILLED HOLE. 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 (B)(4) 16-NOV-2024: FURTHER INFORMATION WAS PROVIDED THE BROKEN PARTS WERE RETRIEVED OUT OF THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20894736 ↗
• MalfunctionNov 21, 2024Break; Break

  IT WAS REPORTED THAT DURING A LABRUM REFIXATION WITH BICEPS SURGERY THE EYELET FROM THE ANCHOR BROKE. ALL FRAGMENTS 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 20749834 ↗
• MalfunctionNov 21, 2024Break; Break

  IT WAS REPORTED THAT DURING A SHOULDER ROTATOR CUFF SURGERY THE ANCHOR OF THE DEVICE BROKE. ALL FRAGMENTS 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 20747615 ↗
• MalfunctionSep 18, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A SHOULDER SURGERY THERE WAS A PROBLEM WITH THE ANCHOR HOLDING ON A PARTICULARLY POROTIC BONE. THE IMPLANT TORE OUT. THE SURGERY WAS FINISHED SUCCESSFULLY WITH REPLACING THE DEVICE BY A LARGER SIZE. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY. UPDATE SWIT 10-SEP-2024: FURTHER INFORMATION WAS PROVIDED THAT NOTHING BROKE OFF. THE ANCHOR JUST PULLED OUT AND DIDN´T HOLD IN THE BONE. THE SURGEON COMPLETED THE SURGERY WITH A LARGER DIAMETER (5.5MM).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20251309 ↗
• MalfunctionJun 27, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ACL SURGERY THE IMPLANT BROKE WHILE SCREWING INTO THE PRE-DRILLED HOLE. 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: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19623852 ↗
• MalfunctionJun 13, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A ROTOR CUFF REPAIR SURGERY THE IMPLANT FELL OUT OF THE BONE WHILE TIGHTENING THE SUTURE. 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 19533884 ↗