Arthrex® AR-1927BCTRecalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 00888867251267), received between Mar 22, 2017 and Jan 12, 2026 — classified as 7 injuries, 20 malfunctions.

The most frequently reported specific device problem is “Break” (22 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 25 most recent of 27 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 12, 2026Material Separation

  ON 24-DEC-2025, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT AN AR-1927BCT BIOCOMPOSITE CORKSCREW FT SUTURE ANCHOR MALFUNCTIONED DURING A ROTATOR CUFF REPAIR PROCEDURE PERFORMED ON (B)(6) 2025. THE ANCHOR INSERTION WAS UNSUCCESSFUL AS THE DEVICE SEPARATED WHILE PARTIALLY SEATED, EXPOSING THE SUTURES. THE SURGEON REMOVED THE ENTIRE ANCHOR AND CONFIRMED THAT IT HAD COMPLETELY COME APART. NO DAMAGE WAS NOTED UPON OPENING OR PRIOR TO INSERTION. THE PROCEDURE WAS COMPLETED USING TWO ADDITIONAL AR-1927BCT BIOCOMPOSITE CORKSCREW FT SUTURE ANCHORS WITHOUT ISSUE. THE CASE WAS NOT DELAYED, AND NO ADDITIONAL ANESTHESIA WAS REQUIRED. NO PATIENT HARM WAS REPORTED. ADDITIONAL INFORMATION WAS REQUESTED ON 29-DEC-2025.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24037855 ↗
• MalfunctionOct 16, 2025Break; Break

  IT WAS REPORTED THAT DURING A SURGERY THE DEVICE BROKE DURING SCREWING IN. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. NO FURTHER INFORMATION RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23312393 ↗
• MalfunctionOct 15, 2025Break; Break

  ON 10/09/2025, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT AN AR-1927BCT BIOCOMPOSITE CORKSCREW FT SUTURE ANCHOR BROKE HALFWAY THROUGH IMPLANTATION. THE BONE WAS PRE-PUNCHED WITH A SILVER CORKSCREW PUNCH AT THE TUBEROSITY FOR A SUPRASPINATUS REPAIR. ALL BROKEN FRAGMENTS WERE REPORTEDLY RETRIEVED. THE CASE WAS COMPLETED, ALTHOUGH PART OF THE ANCHOR REMAINED IN THE PATIENT¿S BONE. THIS WAS DISCOVERED DURING A ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2025. ADDITIONAL INFORMATION WAS RECEIVED ON 10/13/2025: THE NATURE OF THE BREAKAGE OF THE ANCHOR WAS IN HALF, WITH THE TOP THIRD OF THE IMPLANT REMAINING ON THE INSERTER. ALL BROKEN PIECES WERE RETRIEVED FROM THE PATIENT. THE CASE WAS COMPLETED WITH AR-1927BCT BIOCOMPOSITE CORKSCREW FT SUTURE ANCHOR. THE CASE WAS DELAYED FIVE MINUTES, AND IT IS UNKNOWN IF ADDITIONAL ANESTHESIA WAS ADMINISTERED. THE BONE QUALITY OF THE PATIENT WAS ASSESSED AS NORMAL, AND THE AR-1927PB PUNCH WAS USED FOR BONE PREPARATION.

  Patient problems: Foreign Body In Patient

  MAUDE report 23303204 ↗
• MalfunctionJun 24, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ON 05/28/2024, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA EMAIL THAT AN AR-1927BCT-475 BIOCOMPOSITE CORKSCREW FT HAD A SMALL LOOP OF WHITE THREAD INSIDE THE ANCHOR PROTRUDED FROM THE REAR END OF THE ANCHOR, AND THE ANCHOR SUTURE WAS FLOATING FROM THE ANCHOR. THE SURGEON ATTEMPTED TO REMOVE THE ANCHOR BUT WAS UNABLE TO. ANOTHER BONE SOCKET WAS DRILLED AND AN AR-1927BCT BIOCOMPOSITE CORKSCREW FT WAS INSERTER. HOWEVER, THE SAME THING HAPPENED WITH THIS ANCHOR. THE CASE WAS COMPLETED USING AN AR-3633SP FIBERTAK SP. THIS WAS DISCOVERED DURING A PROCEDURE WHEN SUTURING A ROTATOR CUFF TEAR ON (B)(6) 2024.

  Patient problems: Foreign Body In Patient; Insufficient Information

  MAUDE report 19592825 ↗
• MalfunctionApr 5, 2024Break; Break

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY THE ANCHOR TWISTED OFF IMMEDIATELY AND BROKE DESPITE PUNCHING AND THREAD CUTTING. 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 AVOE 26-MAR-2024. IT WAS CONFIRMED THAT ALL FRAGMENTS WERE RETRIEVED FROM THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19051462 ↗
• MalfunctionApr 5, 2024Break; Break

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY THE ANCHOR TWISTED OFF IMMEDIATELY AND BROKE DESPITE PUNCHING AND THREAD CUTTING. 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 AVOE 26-MAR-2024 IT WAS CONFIRMED THAT ALL FRAGMENTS WERE RETRIEVED FROM THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19051428 ↗
• MalfunctionApr 4, 2024Break; Break

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY THE ANCHOR TWISTED OFF IMMEDIATELY AND BROKE DESPITE PUNCHING AND THREAD CUTTING. 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 AVOE 26-MAR-2024 IT WAS CONFIRMED THAT ALL FRAGMENTS WERE RETRIEVED FROM THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19046487 ↗
• MalfunctionJan 12, 2024Positioning Failure; Fitting Problem; Positioning Failure; Fitting Problem

  ON 12/20/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT (QTY. 2) OF AN AR-1927BCT SUTURE ANCHOR, BIOCOMPOSITE CORKSCREW SUTURES WOULD NOT SEAT IN THE IMPLANT; THE LOOP THAT HOLDS THE SUTURE WAS HANGING OUT OF THE ANCHOR AND WAS NOT SECURE. THE CASE WAS COMPLETED BY REMOVING THE ANCHOR AND SUTURES AND INSERTING A NEW AR-1927BCT SUTURE ANCHOR FROM A DIFFERENT LOT. A FEW MINUTES OF DELAY WERE REPORTED IN THE PROCEDURE. THIS WAS DISCOVERED DURING A ROTARY CUFF REPAIR PROCEDURE ON (B)(6) 2023.

  Patient problems: Insufficient Information

  MAUDE report 18502419 ↗
• MalfunctionJan 12, 2024Positioning Failure; Fitting Problem; Positioning Failure; Fitting Problem

  ON 12/20/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT (QTY. 2) OF AN AR-1927BCT SUTURE ANCHOR, BIOCOMPOSITE CORKSCREW SUTURES WOULD NOT SEAT IN THE IMPLANT; THE LOOP THAT HOLDS THE SUTURE WAS HANGING OUT OF THE ANCHOR AND WAS NOT SECURE. THE CASE WAS COMPLETED BY REMOVING THE ANCHOR AND SUTURES AND INSERTING A NEW AR-1927BCT SUTURE ANCHOR FROM A DIFFERENT LOT. A FEW MINUTES OF DELAY WERE REPORTED IN THE PROCEDURE. THIS WAS DISCOVERED DURING A ROTARY CUFF REPAIR PROCEDURE ON (B)(6) 2023.

  Patient problems: Insufficient Information

  MAUDE report 18502384 ↗
• MalfunctionOct 27, 2023Break; Break

  ON 10/05/2023, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA EMAIL THAT AR-1927BCT BIOCOMPOSITE CORKSCREW FT TIP CRACKED. ALL BROKEN FRAGMENTS WERE RETRIEVED, AND THE CASE WAS COMPLETED USING A NEW PRODUCT. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2023. AR-1927BCT USED TO COMPLETE CASE.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18022758 ↗
• MalfunctionOct 25, 2023Break; Break

  ON 9/26/2023, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA EMAIL AN AR-1927BCT BIOCOMPOSITE CORKSCREW FT ANCHOR DID NOT HOLD AND BROKE. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2023.

  Patient problems: Insufficient Information

  MAUDE report 18003536 ↗
• MalfunctionJul 10, 2023Break; Break

  ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-1927BCT BIOCOMPOSITE CORKSCREW ANCHOR BROKE MID-BODY DURING INSERTION. ALL THE BROKEN FRAGMENTS WERE RETRIEVED. THIS WAS DISCOVERED DURING AN RCR PROCEDURE ON (B)(6), 2023. ADDITIONAL INFORMATION RECEIVED ON 6/15/2023: THE CASE WAS COMPLETED USING ANOTHER AR-1927BCT BIOCOMPOSITE CORKSCREW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17288055 ↗
• MalfunctionJul 6, 2023Break; Break

  IT WAS REPORTED THAT DURING A SHOULDER SURGERY THE ANCHOR BROKE INSIDE THE PATIENT. 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: Failure of Implant; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17270310 ↗
• MalfunctionFeb 8, 2023Break

  ON 01/24/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT (2) AR-1927BCT SUTURE ANCHORS BROKE. THIS OCCURRED DURING A ROTATOR CUFF REPAIR ON (B)(6) 2023, WHEN THE SURGEON USED THE PUNCH AND TAP TO PREPARE THE BONE FOR THE ANCHOR AND THE ANCHOR BROKE WHILE BEING INSERTED. A SECOND ANCHOR WAS THEN OPENED AND THE BONE WAS PREPARED AGAIN WITH THE 5.5 CORKSCREW TAP AND THAT ANCHOR BROKE AS WELL. ALL PIECES OF THE ANCHOR WERE REMOVED FROM THE PATIENT, AND THE CASE WAS COMPLETED WITH A THIRD ANCHOR, THE BONE WAS PREPARED WITH THE SAME TAP.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16323618 ↗
• MalfunctionFeb 8, 2023Break

  ON 01/24/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT (2) AR-1927BCT SUTURE ANCHORS BROKE. THIS OCCURRED DURING A ROTATOR CUFF REPAIR ON(B)(6) 2023, WHEN THE SURGEON USED THE PUNCH AND TAP TO PREPARE THE BONE FOR THE ANCHOR AND THE ANCHOR BROKE WHILE BEING INSERTED. A SECOND ANCHOR WAS THEN OPENED AND THE BONE WAS PREPARED AGAIN WITH THE 5.5 CORKSCREW TAP AND THAT ANCHOR BROKE AS WELL. ALL PIECES OF THE ANCHOR WERE REMOVED FROM THE PATIENT, AND THE CASE WAS COMPLETED WITH A THIRD ANCHOR, THE BONE WAS PREPARED WITH THE SAME TAP.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16323616 ↗
• MalfunctionDec 6, 2022Crack

  ON (B)(6) 2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT (2) AR-1927BCT BIO-COMPOSITE CORKSCREW FT ANCHORS CRACKED DURING INSERTION. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2022.

  Patient problems: Insufficient Information

  MAUDE report 15923822 ↗
• MalfunctionDec 6, 2022Crack

  ON 11/21/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT (2) AR-1927BCT BIO-COMPOSITE CORKSCREW FT ANCHORS CRACKED DURING INSERTION. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2022.

  Patient problems: Insufficient Information

  MAUDE report 15923753 ↗
• InjuryNov 16, 2022Break

  ON (B)(6) 2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT (2) AR-1927BCT SUTURE ANCHORS SUTURES BROKE. THIS OCCURRED DURING A ROTATOR CUFF REPAIR ON (B)(6) 2022 AFTER PASSING BOTH SUTURE TAPES THEY WENT TO THEM AND WHEN THEY PULLED DOWN THE SUTURE TORE. THE FIRST ANCHOR REMAINED SECURELY IN THE PATIENT. THE SECOND ONE WHEN THE SUTURES PULLED OUT IT BACKED OUT. THE CASE WAS COMPLETED BY PASSING FREE SUTURES, AND PULLING DOWN TO THE SWIVELOCK. THERE WAS NO PATIENT EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15803939 ↗
• MalfunctionMay 23, 2022Break

  ON (B)(6) 2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT A AR-1927BCT SUTURE ANCHOR BROKE. THIS OCCURRED ON (B)(6) 2022 DURING A ROTATOR CUFF REPAIR AFTER THE BONE WAS PREPPED WITH THE PUNCH JUST AS THE SURGEON BEGAN TO SCREW THE ANCHOR IN IT BROKE. THE SUTURE ANCHOR WAS RETRIEVED, AND THE CASE WAS COMPLETED USING ANOTHER AR-1927BC. THERE WAS NO PATIENT EFFECT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14468528 ↗
• MalfunctionApr 12, 2021Break

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY THREE DEVICES FROM THE ARTICLE AR-1927BCT (LOT 11567964) BROKE DURING SCREWING IN. NO BROKEN PARTS REMAINED 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 11647666 ↗
• MalfunctionMar 24, 2020Break

  DURING PROCEDURE A ANCHOR BROKE OFF IN THE PATIENT. ALL PIECES RETRIEVED AND SAVED. NEW ANCHOR OPENED AND USED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9871215 ↗
• InjuryMar 5, 2019Break

  IT WAS REPORTED THAT DURING A CASE, THE SURGEON PILOTED THE PATIENT'S BONE WITH AN AR-1927PB. AS HE WAS INSERTING THE IMPLANT, ABOUT HALFWAY THROUGH, THE AR-1927BCT BROKE IN HALF. THE BROKEN PIECE WAS RETRIEVED FROM THE PATIENT BUT THE DISTAL PORTION STAYED INSIDE OF THE PATIENT'S BONE. THE CASE WAS COMPLETED WITH NO FURTHER INCIDENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8390946 ↗
• InjuryApr 18, 2018Break; Material Separation

  DURING MAUDE REVIEW IT WAS DISCOVERED THAT A USER FACILITY HAD REPORTED THE FOLLOWING: "SUTURE ANCHOR WAS BEING IMPLANTED WHEN THE IMPLANT BROKE IN HALF. PER SURGEON 2-3 MM TIP REMAINED IN PATIENT, IRRETRIEVABLE WITHOUT HARMING THE BONE. NO HARM TO PATIENT AND PROCEDURE WAS COMPLETED SUCCESSFULLY." MAUDE REPORT DID NOT CONTAIN FACILITY/REPORTER NAME OR CONTACT INFORMATION. THEREFORE NO FOLLOW-UP IS POSSIBLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 7439295 ↗
• InjuryApr 5, 2018Break; Entrapment of Device

  IT WAS REPORTED, THE DOCTOR DRILLED TO PREPARE THE HOLE. SURGEON BROKE THE AR-1927BCT, CORKSCREW UPON INSERTION. ONLY THE ANCHOR REMAINED IN THE BODY. SURGEON MADE CLEAN THE BROKEN SCREW WITH A SHAVER. A NEW ONE WAS USED AND THE CASE COMPLETED. FOLLOW-UP INVESTIGATION: PROCEDURE WAS A SMALL SUPRASPASM REPAIR. WHEN THE SURGEON SCREWED THE SCREW IN FOUR TURNS THE SCREW BROKE INTO TWO PIECES. THE TIP OF THE SCREW REMAINED IN THE BODY. THE BROKEN SURFACE WAS ROUGH AND THE SURGEON LEVELED THE BROKEN SURFACE BY USING A SHAVER TO MAKE IT FLUSH WITH THE BONE. A NEW SCREW WAS USED TO COMPLETE THE PROCEDURE. THE NEW SCREW WAS PLACED BESIDE THE BROKEN SCREW. NO ADDITIONAL INCISIONS WERE NEEDED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 7398741 ↗
• InjuryMar 15, 2018Break; Crack

  IT WAS ORIGINALLY REPORTED THAT THE SUTURE ANCHOR BROKE ON INSERTION. NO FURTHER DETAILS. AVAILABLE AT TIME OF INITIAL REPORT. FOLLOW-UP INVESTIGATION: IT WAS REPORTED THAT DURING AN OPEN ROTATOR CUFF REPAIR PROCEDURE, THE BIO-COMPOSITE CORKSCREW CRACKED AND BROKE ON INSERTION. MOST OF THE ANCHOR WAS RETRIEVED, BUT THE REP IS NOT SURE IF THE ENTIRE ANCHOR WAS PULLED OUT AFTER IT CRACKED AND BROKE. A DIFFERENT ANCHOR (AR-1928SF-3) WAS USED TO COMPLETE THE REPAIR. ORIGINALLY, THE SURGEON HAD THE RESIDENT PUNCH AND INSERT AR-1927BCT. UPON PUNCHING, THE REP NOTICED THE RESIDENT WAS HAVING DIFFICULTY GETTING THE PUNCH IN THE BONE, AND IT SOUNDED AS IF THE BONE WAS VERY HARD. THE REP RECOMMENDED THE SURGEON AND/OR RESIDENT USE THE TAP ASSOCIATED WITH AR-1927BCT, AS IT WAS READILY AVAILABLE IN A TRAY IN THE ROOM. HOWEVER, THE SURGEON DID NOT WANT TO OPEN THE TRAY, AND DECIDED AGAINST USING THE TAP THE REP RECOMMENDED. ONCE THE DECISION WAS MADE BY THE SURGEON TO NOT USE THE TAP, THE REP REMINDED THE SURGEON AND RESIDENT THE ANCHOR MUST BE INSERTED AT THE SAME ANGLE AT WHICH THE PUNCH WAS USED. FOLLOWING THE SURGEON'S INSTRUCTION, THE RESIDENT INSERTED AR-1927BCT AFTER PUNCHING (WITHOUT US

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7341115 ↗