Arthrex® AR-1927BCF-475Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00888867238541), received between Sep 7, 2021 and Feb 18, 2025 — classified as 7 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 18, 2025Break; Break

  ON (B)(6) 2025, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA EMAIL THAT AN AR-1927BCF-475 BIOCOMPOSITE CORKSCREW FT ANCHOR BROKE WHEN IT WAS IMPLANTED AND TURNED CLOCKWISE. ALL THE BROKEN FRAGMENTS WERE REMOVED, AND THE CASE WAS COMPLETED USING ANOTHER R-1927BCF-475 BIOCOMPOSITE CORKSCREW FT. THIS WAS DISCOVERED DURING AN RCR PROCEDURE ON (B)(6) 2025. THE CASE WAS NOT DELAYED, AND ADDITIONAL ANESTHESIA WAS NOT NEEDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21395241 ↗
• MalfunctionNov 28, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON (B)(6) 2023, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA EMAIL THAT AN AR-1927BCF-475 BIOCOMPOSITE CORKSCREW FT TRIPLEPLAY PULLED OUT AFTER INSERTION. THE CASE WAS COMPLETED USING ANOTHER AR-1927BCF-475 BIOCOMPOSITE CORKSCREW FT TRIPLEPLAY. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2023.

  Patient problems: Insufficient Information

  MAUDE report 18220724 ↗
• MalfunctionAug 24, 2023Break; Break

  ON (B)(6) 2023, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT AN AR-1927BCF-475 BIOCOMPOSITE CORKSCREW FT TRIPLEPLAY ANCHOR BROKE DURING INSERTION. THE CASE WAS COMPLETED USING ANOTHER AR-1927BCF-475 BIOCOMPOSITE CORKSCREW FT TRIPLEPLAY. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2023. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2023: THIS WAS DISCOVERED DURING AN RCR PROCEDURE, AND ALL BROKEN FRAGMENTS WERE REMOVED.

  Patient problems: Insufficient Information

  MAUDE report 17611275 ↗
• MalfunctionJan 16, 2023Break

  IT WAS REPORTED ON (B)(6) 2022 BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-1927BCF-475 CORKSCREW ANCHOR BROKE INTO PIECES. CASE INVOLVEMENT, DEVICE BROKE DURING USE.PER FACILITY: THE BONE SOCKET WAS PREPARED WITH THE 4.75 CORKSCREW PUNCH/TAP AND THE BONE WAS TAPPED TWICE. UPON INSERTION, THE ANCHOR BROKE PRIOR TO THE LAST 3-4 THREADS BEING FULLY SEATED. OUTCOME: THE ENTIRE ANCHOR WAS ABLE TO BE RETRIEVED FROM THE PATIENT IN MULTIPLE PIECES.THE SAME HOLE WAS TAPPED WITH A 5.5 TAP AND A 5.5 CORKSCREW WAS UNSUCCESSFULLY ATTEMPTED TO BE INSERTED. THE DOCTOR COMPLETED THE PROCEDURE BY DRILLING AND TAPPING IN AN ALTERNATIVE AREA ON THE BONE, USING 5.5 CORKSCREW.

  Patient problems: Foreign Body In Patient; Insufficient Information

  MAUDE report 16173455 ↗
• MalfunctionMay 16, 2022Break

  ON 04/27/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT A AR-1927BCF-475 SUTURE ANCHOR BROKE. THIS OCCURRED ON 04/25/2022 DURING A ROTATOR CUFF REPAIR WHEN THE ANCHOR WAS IMPLANTED AND BACKED OUT. WHEN THE ANCHOR BACKED OUT IT WAS DISCOVERED THAT IT HAD BROKE INSIDE THE PATIENT. THE BROKEN FRAGMENT WAS REMOVED, AND THE CASE WAS COMPLETED USING A LARGER ANCHOR THAT WORKED FINE. THERE WAS NO PATIENT EFFECT REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 14407051 ↗
• MalfunctionOct 4, 2021Break; Material Split, Cut or Torn; Sharp Edges

  ON (B)(6) 2021 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-1927BCF-475 CORKSCREW'S HANDLE SHEARED OFF AT THE PROXIMAL EDGE OF THE IMPLANT CAUSING SHARP EDGED THAT ENDED UP CUTTING THE SUTURES. THIS WAS DISCOVERED DURING A SUBSCAPULARIS REPAIR ON (B)(6) 2021. SURGEON USED AN EASY OUT TO RETRIEVE MOST OF THE METAL AND TO PULL OUT THE ANCHOR. BY USING ANOTHER ANCHOR, SURGEON WAS ABLE TO COMPLETE CASE SUCCESSFULLY WITH NO PATIENT AFFECTED. ADDITIONAL INFO REQUESTED. ADDITIONAL INFO RECEIVED 09/16/2021: DEVICE BROKE UPON THE FINAL TURN OF INSERTION AND THE BROKEN SHARP EDGED CUTE INTO THE SUTURES. DEVICE WILL NOT BE RETUNED AS I WAS DISCARDED BY FACILITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12571546 ↗
• MalfunctionSep 7, 2021Break

  ON 08/17/2021, IT WAS REPORTED BY A ARTHREX EMPLOYEE VIA E-MAIL THAT WHILE USING AN AR-1927BCF-475 CORKSCREW, THE SUTURE ANCHOR BROKE AFTER THE BONE HOLE WAS CREATED AS SPECIFIED 4.75 MM. THE CASE WAS COMPLETED WITH A NEW AR-3680. ADDITIONAL INFORMATION PROVIDED 8/20/21: THE SUTURE ANCHOR WAS REMOVED FROM THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12435024 ↗