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

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00888867098022), received between May 3, 2021 and Feb 7, 2025 — classified as 1 injury, 8 malfunctions.

The most frequently reported specific device problem is “Break” (6 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 7, 2025Break; Break

  IT WAS REPORTED THAT DURING A SPEED BRIDGE ROTATOR CUFF REPAIR SURGERY THE ANCHOR BROKE OFF WHILE IT WAS SCREWED IN. 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 DW 28-JAN-2025: FURTHER INFORMATION WAS PROVIDED THAT THE BROKEN TIP WAS RETRIEVED OUT OF THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21333830 ↗
• MalfunctionJun 13, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY THE IMPLANT EJECTED FROM BONE DURING STABILITY CHECK. 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 19532725 ↗
• MalfunctionNov 10, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A SHOULDER SURGERY ON INSERTING THE ANCHOR INTO THE PATIENT'S SHOULDER IT WAS NOTICED THAT THE ANCHOR HAD COME LOOSE FROM THE GREEN HOLDER. IT WAS IMPOSSIBLE TO REPLACE THE ANCHOR ON THE GREEN SCREWDRIVER. 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 18111578 ↗
• MalfunctionAug 4, 2023Break; Break

  IT WAS REPORTED THAT DURING A LIGAMENTOPLASTY SURGERY THE ANCHOR BROKE DURING INSTALLATION. ALL BROKEN PARTS WERE 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 17459592 ↗
• MalfunctionFeb 13, 2023Break

  IT WAS REPORTED THAT DURING A ROTATOR CUFF SUTURE SURGERY THE DEVICE BROKE OFF DURING THE IMPLANTATION. 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 16361787 ↗
• MalfunctionSep 6, 2022Break

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY THE SCREW TIP BROKE OFF INSIDE THE PATIENT. THE BROKEN PIECE WAS 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 15362436 ↗
• MalfunctionMay 9, 2022Break

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY THE SCREW TIP BROKE OFF. 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 14336773 ↗
• InjuryFeb 14, 2022Patient-Device Incompatibility

  IT WAS REPORTED THAT A PATIENT HAS AN ALLERGY WITH AN INFLAMMATORY REACTION TO THE MATERIAL PLACED IN THE KNEE IN (B)(6) 2021. NO FURTHER INFORMATION WERE PROVIDED. 27-JAN-2022 UPDATE: FURTHER INFORMATION WERE PROVIDED THAT NO ADDITIONAL SURGERY WILL BE PERFORMED.

  Patient problems: Hypersensitivity/Allergic reaction; Inflammation

  MAUDE report 13525814 ↗
• MalfunctionMay 3, 2021Break

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY THE DEVICE DID NOT TIGHTEN AND BROKE INTO THE PATIENT'S BONE. THE BROKEN OFF PIECE WAS RETRIEVED FROM THE PATIENT. 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.

  Patient problems: Insufficient Information

  MAUDE report 11761549 ↗