Arthrex® AR-2323BCC-1Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00888867097919), received between May 24, 2021 and Feb 21, 2025 — classified as 15 malfunctions.

The most frequently reported specific device problem is “Break” (7 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 21, 2025Break; Break

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR ON THE RIGHT SHOULDER THE END OF THE ANCHOR BROKE OFF IN THE PATIENT'S SHOULDER AND COULD NOT BE CAUGHT BY THE RETURN WIRE. THE PART REMAINED IN THE PATIENT. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: Foreign Body In Patient

  MAUDE report 21433585 ↗
• MalfunctionMay 8, 2024Failure to Advance; Failure to Advance

  NO INFORMATION WAS RECEIVED WITH THIS DEVICE. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. UPDATE NEN 24-OCT-2022: FURTHER INFORMATION WAS PROVIDED AND REVEALED THAT THE INCIDENT OCCURRED DURING A SURGERY. THE ANCHOR WOULD NOT SEAT AND WENT OUT. THE ANCHOR WAS SUCCESSFULLY REMOVED FROM THE PATIENT AND NOTHING BROKE OFF. 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 19267052 ↗
• MalfunctionApr 24, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY SURGERY WHEN IMPLANTING THE DEVICE THE MATERIAL OF THE ANCHOR SHEARED OFF. NO PART OF THE DEVICE BROKE OFF. ACCORDING TO THE SURGEON NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY OCCURRED. 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 19174623 ↗
• MalfunctionNov 6, 2023Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT DURING A KNEE SURGERY DURING SCREWING OF THE SWIVELOCK WITH 4 WIRES, THERE WAS A FAILURE. WITH SCREWING WITH ROTATION OF THE WIRES AROUND THE ANCHOR, IT WAS IMPOSSIBLE TO GET INTO THE FOOTPRINT DESPITE THE USE OF THE NEEDLE AS USUALLY RECOMMENDED. 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 SWIT 13-OCT-2023: THE SWIVELOCK WAS SCREWED IN WITH 4 WIRES, BUT FAILED TO SCREW IN AS THE WIRES ROTATED AROUND THE ANCHOR. IT WAS IMPOSSIBLE TO GET INTO THE FOOTPRINT DESPITE USING THE NEEDLE AS USUALLY RECOMMENDED. MULTIPLE ATTEMPTS FAILED. THEN THEY TRIED A NEW ANCHOR AND SUCCESSFULLY SCREWED IN AND IMPLANTED THE NEW ANCHOR WITHOUT ANY DIFFICULTY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18074057 ↗
• MalfunctionNov 1, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE ANCHOR DID NOT HOLD AND WAS PULLED OUT DURING A ROTATOR CUFF SURGERY. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH DIFFERENT 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 18047362 ↗
• MalfunctionNov 1, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE ANCHOR DID NOT HOLD AND WAS PULLED OUT DURING A ROTATOR CUFF SURGERY. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH DIFFERENT 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 18046664 ↗
• MalfunctionAug 2, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT SURGERY THE IMPLANT WAS LOOSE AFTER TIGHTENING, IT DID NOT HOLD IN THE BONE. 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 17442347 ↗
• MalfunctionMay 11, 2023Break; Break

  IT WAS REPORTED THAT DURING A ROTATOR CUFF SURGERY THE ANCHOR BROKE WHEN IT WAS IMPLANTED. THE BROKEN PIECES WERE RETRIEVED OUT OF THE PATIENT. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16915900 ↗
• MalfunctionNov 14, 2022Positioning Problem

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY THE IMPLANT COULD NOT BE ANCHORED. ACCORDING TO THE SURGEON 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. DURING RETURNED DEVICE EVALUATION, A REPORTABLE MALFUNCTION WAS DISCOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15788267 ↗
• MalfunctionJul 25, 2022Break

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY SURGERY THE SCREW BROKE WHEN THE SURGEON PUT THE SCREW ON THE BLUE SCREWDRIVER. THE SURGEON TURNED IT AND IT BROKE OFF PRIOR TO FULL INSERTION TO INTENDED DEPTH INSIDE THE PATIENT. ACCORDING TO THE SURGEON NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY OCCURRED. 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 15093392 ↗
• MalfunctionMay 23, 2022Break

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY BOTH ANCHOR BROKE OFF INSIDE THE PATIENT DURING INSERTION. THE BROKEN PIECES WERE RETRIEVED FROM PATIENT. 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 14468835 ↗
• MalfunctionSep 21, 2021Break

  IT WAS REPORTED THAT DURING SHOULDER ARTHROSCOPY SURGERY BOTH ANCHORS DID BREAK OFF WHILE INSERTING. THE BROKEN OFF PIECE HAS BEEN RETRIEVED FROM THE PATIENT. 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. NO FURTHER INFORMATION RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12507404 ↗
• MalfunctionJul 27, 2021Break

  IT WAS REPORTED THAT DURING ROTATOR CUFF SURGERY THE DEVICE BROKE WHILE IMPLANTING IT INTO THE HUMERUS TO SECURE THE SUTURES OF THE CAP REPAIR ASSEMBLY. THE BROKEN OFF PIECE WAS RETRIEVED FROM THE PATIENT. ACCORDING TO THE SURGEON NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY OCCURRED. 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 12231601 ↗
• MalfunctionMay 24, 2021Defective Device

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY IT WAS NOT POSSIBLE TO SCREW THE DEVICES IN AND THE THREAD OF BOTH DEVICES IS DEFECT. NO PART OF THE DEVICE BROKE OFF. ACCORDING TO THE SURGEON NO HARM OR ADVERSE EVENT FOR PATIENT, OPERATOR OR THIRD PARTY OCCURRED. 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 11-MAY-2021: IT WAS REPORTED THAT NO BROKEN PARTS REMAINED INSIDE THE PATIENT. ALTHOUGH THE ANCHOR BROKE NO PARTS OF THE DEVICE CAME OFF AND THE DEVICE COULD BE REMOVED IN ONE PART.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11872333 ↗
• MalfunctionMay 24, 2021Break

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY THE TIP OF THE DEVICE BROKE INSIDE THE PATIENT. THE BROKEN PIECE WAS RETRIEVED FROM THE PATIENT. ACCORDING TO THE SURGEON NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY OCCURRED. 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 11872295 ↗