Arthrex® AR-2923BC-1Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00888867269170), received between Apr 28, 2023 and Dec 10, 2025 — classified as 13 malfunctions.

The most frequently reported specific device problem is “Break” (5 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 10, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING THE SHOULDER SURGERY, THE WIRE HAD COME LOOSE FROM THE 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 23770781 ↗
• MalfunctionDec 10, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING THE SHOULDER SURGERY, THE WIRE HAD COME LOOSE FROM THE 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 23770671 ↗
• MalfunctionDec 10, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING THE SHOULDER SURGERY, THE WIRE HAD COME LOOSE FROM THE 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 23770568 ↗
• MalfunctionDec 10, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING THE SHOULDER SURGERY, THE WIRE HAD COME LOOSE FROM THE 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 23770487 ↗
• MalfunctionSep 15, 2025Failure to Advance; Failure to Advance

  ON 22ND AUGUST 2025, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT FOR AN AR-2923BC-1, SUTURE ANCHOR, BIOCOMPOSITE PUSHLOCK®, SL 2.9 MM X 12.5 MM, THE PUSHLOCK ANCHOR WAS DAMAGED ON INSERTION INTO GLENOID AND WOULD NOT ADVANCE. THIS WAS DETECTED DURING USE IN A LABRAL REPAIR PROCEDURE ON (B)(6) 2025. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AS THEY USED ANOTHER ANCHOR. PATIENT BONE QUALITY WAS AS EXPECTED FOR AGE. THE CORRECT GUIDE AND DRILL WERE USED FOR PREPARATION OF THE BONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23051850 ↗
• MalfunctionJul 28, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON 10TH JULY 2025, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT FOR AN AR-1588R-IB, ACL REPAIR TIGHTROPE®, WITH INTERNALBRACE¿ LIGAMENT AUGMENTATION, AS THE SURGEON WAS PERFORMING AN ACL REPAIR, ON FINAL TENSIONING OF THE ACL REPAIR TIGHTROPE, ONE OF THE TIGHTROPE TAILS SNAPPED BELOW THE BUTTON. IT WAS ALSO REPORTED THAT 2 UNITS OF AR-2923BC-1, SUTURE ANCHOR, BIOCOMPOSITE PUSHLOCK®, SL 2.9 MM X 12.5 MM, SEQUENTIALLY PULLED OUT AFTER INSERTION. THIS WAS DETECTED DURING USE IN AN ACL REPAIR PROCEDURE ON (B)(6) 2025. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AS THE SURGEON LOADED THE REMAINING TIGHTROPE TAIL INTO A 2.9 PUSHLOCK FOR INSERTION INTO THE FEMUR FOR EXTRA FIXATION AND THE SURGEON RESORTED TO USING A 3.5MM SWIVELOCK FOR THE 2 AR-2923BC-1 THAT WERE PULLED OUT.

  Patient problems: Insufficient Information

  MAUDE report 22639649 ↗
• MalfunctionJul 28, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON 10TH JULY 2025, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT FOR AN AR-1588R-IB, ACL REPAIR TIGHTROPE®, WITH INTERNALBRACE¿ LIGAMENT AUGMENTATION, AS THE SURGEON WAS PERFORMING AN ACL REPAIR, ON FINAL TENSIONING OF THE ACL REPAIR TIGHTROPE, ONE OF THE TIGHTROPE TAILS SNAPPED BELOW THE BUTTON. IT WAS ALSO REPORTED THAT 2 UNITS OF AR-2923BC-1, SUTURE ANCHOR, BIOCOMPOSITE PUSHLOCK®, SL 2.9 MM X 12.5 MM, SEQUENTIALLY PULLED OUT AFTER INSERTION. THIS WAS DETECTED DURING USE IN AN ACL REPAIR PROCEDURE ON (B)(6) 2025. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AS THE SURGEON LOADED THE REMAINING TIGHTROPE TAIL INTO A 2.9 PUSHLOCK FOR INSERTION INTO THE FEMUR FOR EXTRA FIXATION AND THE SURGEON RESORTED TO USING A 3.5MM SWIVELOCK FOR THE 2 AR-2923BC-1 THAT WERE PULLED OUT.

  Patient problems: Insufficient Information

  MAUDE report 22637934 ↗
• MalfunctionJun 2, 2025Break; Break

  IT WAS REPORTED THAT DURING A BANKART REPAIR SURGERY THE ANCHOR BROKE DURING INSERTION INTO THE DRILLING HOLE. ALL 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 ANOTHER SWIVELOCK SUTURE ANCHOR. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22125274 ↗
• MalfunctionJun 2, 2025Break; Break

  IT WAS REPORTED THAT DURING A BANKART REPAIR SURGERY THE ANCHOR BROKE DURING INSERTION INTO THE DRILLING HOLE. ALL 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 ANOTHER SWIVELOCK SUTURE ANCHOR. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22124452 ↗
• MalfunctionJun 2, 2025Break; Break

  IT WAS REPORTED THAT DURING A BANKART REPAIR SURGERY THE ANCHOR BROKE DURING INSERTION INTO THE DRILLING HOLE. ALL 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 ANOTHER SWIVELOCK SUTURE ANCHOR. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22123665 ↗
• MalfunctionDec 31, 2024Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT DURING A LABRUM REFIX SURGERY THE ANCHOR DID NOT HOLD AND CAME OUT AGAIN. 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 21046787 ↗
• MalfunctionAug 30, 2023Break; Break

  IT WAS REPORTED THAT DURING A SHOULDER SURGERY THE TIP OF THE ANCHOR BROKE OFF. 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 01-AUG-2023 NEN: THE BROKEN PIECES WERE RETRIEVED FROM PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17651344 ↗
• MalfunctionApr 28, 2023Break; Break

  IT WAS REPORTED THAT DURING A SURGERY THE ANCHOR BROKE IN TWO PARTS WHEN INSERTING THE DEVICE WITHOUT APPLYING PRESSURE. THE EYELET WAS NOT DAMAGED. THE TWO BROKEN PARTS WERE RETRIEVED FROM THE PATIENT. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. NO FURTHER INFORMATION RECEIVED. UPDATE AVOE 03-APR-2023 FURTHER INFORMATION WAS PROVIDED THAT THE ERROR OCCURRED DURING A LABRUM REFIXATION SURGERY. 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. UPDATE, KHE, 26-APR-2023 FURTHER INFORMATION WAS RECEIVED WITH THE DEVICE. ONLY THE BROKEN PART WAS SENT IN, THE AR-2923BC-1 WAS DISCARDED.

  Patient problems: Failure of Implant; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16838879 ↗