Arthrex® AR-1927BCF-45-1Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00888867282391), received between Jun 28, 2021 and Feb 16, 2026 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Break” (10 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 16, 2026Break

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR SURGERY THE ANCHOR 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 24344761 ↗
• MalfunctionFeb 16, 2026Break

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR SURGERY THE ANCHOR 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 24344759 ↗
• MalfunctionAug 5, 2025Break; Break

  IT WAS REPORTED THAT, DURING A ROTATOR CUFF REPAIR SURGERY, THE IMPLANT BROKE WHILE BEING INSERTED INTO A PREDRILLED 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 22713606 ↗
• MalfunctionJul 25, 2024Break; Break

  IT WAS REPORTED THAT DURING A ROTOR CUFF SURGERY THE DEVICE BROKE WHILE SCREWING IN. 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 19826752 ↗
• MalfunctionJun 10, 2024Break; Break

  IT WAS REPORTED THAT DURING A ROTATOR CUFF SUTURE THE DEVICE BROKE OFF WHEN SCREWING IN. 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 19497486 ↗
• MalfunctionMay 8, 2024Break; Break

  ON 04/15/2024, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA EMAIL THAT AN AR-1927BCF-45-1 BIOCOMPOSITE-CORKSCREW ANCHOR BROKE DURING INSERTION. ALL THE BROKEN FRAGMENTS WERE REMOVED SUCCESSFULLY. ANOTHER AR-1927BCF-45-1 BIOCOMPOSITE-CORKSCREW WAS USED TO COMPLETE THE REPAIR. THIS WAS DISCOVERED DURING AN RCR PROCEDURE ON (B)(6) 2024. THE PATIENT SUFFERED NO NEGATIVE EFFECTS. ADDITIONAL INFORMATION RECEIVED ON 4/29/2024: THIS WAS DISCOVERED DURING A MILD OSTEOPOROSIS PROCEDURE. THE CASE WAS NOT DELAYED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19270590 ↗
• MalfunctionJan 5, 2024Break; Break

  ON 12/11/2023, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA EMAIL THAT AN AR-1927BCF-45-1 BIO COMPOSITE CORKSCREW ANCHOR BROKE DURING INSERTION. THE CASE WAS COMPLETED USING ANOTHER AR-1927BCF-45-1 BIO COMPOSITE CORKSCREW FROM THE SAME LOT NUMBER. THIS WAS DISCOVERED DURING AN RCR PROCEDURE ON (B)(6) 2023. ALL THE BROKEN FRAGMENTS WERE REMOVED, AND THE CASE WAS DELAYED TEN MINUTES; HOWEVER, NO ADDITIONAL ANESTHESIA WAS NEEDED. ADDITIONAL INFORMATION RECEIVED ON 12/18/2023: THE PATIENT SUFFERED NO NEGATIVE EFFECTS ON OR AFTER THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18456561 ↗
• MalfunctionJan 5, 2024Break; Break

  ON 12/11/2023, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE THAT AN AR-1927BCF-45-1 BIO COMPOSITE CORKSCREW ANCHOR BROKE DURING INSERTION. THE CASE WAS COMPLETED USING AN AR-1934BCF-45-1 SUTURETAK THIS WAS DISCOVERED DURING AN RCR PROCEDURE ON (B)(6) 2023. ALL THE BROKEN FRAGMENTS WERE REMOVED, AND THE CASE WAS DELAYED TEN MINUTES; HOWEVER, NO ADDITIONAL ANESTHESIA WAS NEEDED. THE PATIENT SUFFERED NO NEGATIVE EFFECTS ON OR AFTER THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18453180 ↗
• MalfunctionJan 5, 2024Break; Break

  ON 12/11/2023, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE THAT AN AR-1927BCF-45 CORKSCREW FT ANCHOR BROKE DURING INSERTION. THE CASE WAS COMPLETED USING ANOTHER AR-1927PCF-45 CORKSCREW. THIS WAS DISCOVERED DURING AN RCR PROCEDURE ON (B)(6) 2023. ALL THE BROKEN FRAGMENTS WERE REMOVED, AND THE CASE WAS DELAYED TEN MINUTES; HOWEVER, NO ADDITIONAL ANESTHESIA WAS NEEDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18453082 ↗
• MalfunctionJan 5, 2024Material Fragmentation; Material Fragmentation

  ON 12/11/2023, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE THAT AN AR-1927BCF-45 CORKSCREW FT ANCHOR BROKE DURING INSERTION. THE CASE WAS COMPLETED USING ANOTHER AR-1927PCF-45 CORKSCREW FT. THIS WAS DISCOVERED DURING AN RCR PROCEDURE ON (B)(6) 2023. ALL THE BROKEN FRAGMENTS WERE REMOVED, AND THE CASE WAS DELAYED FIFTEEN MINUTES; HOWEVER, NO ADDITIONAL ANESTHESIA WAS NEEDED. THE PATIENT SUFFERED NO NEGATIVE EFFECTS ON OR AFTER THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18452544 ↗
• MalfunctionJun 28, 2021Break

  IT WAS REPORTED THAT DURING A ROTATOR CUFF SURGERY THE DEVICE BROKE INSIDE THE PATIENT UNDER DURESS. 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 DIFFERENT DEVICE. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12075564 ↗