Arthrex® AR-1927BCFRecalls & reported problems

Summary

The FDA's MAUDE database contains 42 adverse event reports that list this exact device (DI 00888867023352), received between Oct 3, 2016 and Sep 9, 2026 — classified as 15 injuries, 27 malfunctions.

The most frequently reported specific device problem is “Break” (32 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 42 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 9, 2026Positioning Failure

  It was reported that during an arthroscopic shoulder surgery the device did not grip the bone. 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 50690737 ↗
• InjuryJan 22, 2026Patient Device Interaction Problem

  UPDATE ON 26-MAR-2026 - FURTHER INFORMATION WAS RECEIVED: UPON REVIEWING THE SURGICAL IMAGES FROM (B)(6) 2022, THE SURGEON HAS NOT NOTICED ANY ABNORMALITIES SO FAR. IT IS NOT POSSIBLE TO CONCLUSIVELY DETERMINE WHETHER THE SYMPTOMS DESCRIBED BY THE PATIENT WERE CAUSED BY A MEDICAL DEVICE. IN ADDITION, THE SURGEON CONFIRMED THAT NO BROKEN PIECES OR METAL DEBRIS FROM THE BURR REMAINED INSIDE THE PATIENT.

  Patient problems: Dizziness; Nausea; Pain

  MAUDE report 24144167 ↗
• MalfunctionDec 30, 2025Break; Break

  IT WAS REPORTED THAT DURING THE SHOULDER ARTHROSCOPY, THE ANCHOR BROKE WHILE BEING INSERTED INTO THE BONE. THE BROKEN PIECES 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 23921827 ↗
• MalfunctionOct 30, 2025Break; Break

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR SURGERY THE ANCHOR BROKE. 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 23427297 ↗
• MalfunctionAug 15, 2025Defective Device; Defective Device

  IT WAS REPORTED THAT DURING A SURGERY THE SCREW TIP GOT DEFECTIVE DURING IMPLANTATION AND THE DEVICE THEREFORE BECAME UNUSABLE. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. NO FURTHER INFORMATION RECEIVED. UPDATE AVOE ON 21-JUL-2025: IT WAS CONFIRMED THAT THE ERROR OCCURRED DURING AN ARTHROSCOPIC REFIXATION AND PLASTIC SURGERY ON THE CAPSULAR LIGAMENT APPARATUS OF THE SHOULDER JOINT. 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 22819237 ↗
• MalfunctionJul 14, 2025Break; Break

  ON 06/17/2025, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT AN AR-1927BCF BIOCOMPOSITE CORKSCREW FT SUTURE ANCHOR BROKE DURING INSERTION. A NEW PRODUCT WAS OPENED TO COMPLETE THE CASE. THE PATIENT WAS NOT AFFECTED. THIS WAS DISCOVERED DURING A PROXIMAL HAMSTRING SURGERY ON (B)(6) 2025. ADDITIONAL INFORMATION WAS RECEIVED ON 07/01/2025: ALL FRAGMENTS WERE REMOVED FROM THE PATIENT, AND THE CASE WAS COMPLETED WITHOUT SIGNIFICANT DELAYS OR ADDITIONAL ANESTHESIA. THE CASE WAS COMPLETED USING ANOTHER ANCHOR. THE SOCKET WAS CREATED WITH A 5.5 PUNCH AND TAP. THE PATIENT'S BONE QUALITY WAS ASSESSED AS GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22500486 ↗
• MalfunctionMar 4, 2025Break; Break

  IT WAS REPORTED THAT DURING A ROTATOR CUFF SURGERY THE THREAD OF THE DEVICE BROKE AS SOON AS IT WAS INSERTED BEFORE BEING TURNED. ALL FRAGMENTS 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 21517817 ↗
• MalfunctionFeb 7, 2025Break; Break

  ON 01/22/2025, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT (QTY. 2) OF AN AR-1927BCF BIOCOMPOSITE CORKSCREW FT SUTURE ANCHOR BROKE DURING USE. THE PATIENT WAS NOT HARMED AS A RESULT OF ANCHOR BREAKAGE. THIS WAS DISCOVERED DURING A PROCEDURE, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED. ADDITIONAL INFORMATION RECEIVED ON 1/28/2025: UPON INSERTION OF THE BIOCOMPOSITE CORKSCREW, THE ANCHORS BROKE. ALL THE BROKEN FRAGMENTS WERE REMOVED FROM THE PATIENT. THE CASE WAS COMPLETE USING ANOTHER R-1927BCF BIOCOMPOSITE CORKSCREW. THE CASE WAS NOT DELAYED, AND ADDITIONAL ANESTHESIA WAS NOT NEEDED. THIS WAS DISCOVERED DURING AN RCR PROCEDURE ON (B)(6) 2025.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21333042 ↗
• MalfunctionFeb 7, 2025Break; Break

  ON (B)(6) 2025, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT (QTY. 2) OF AN AR-1927BCF BIOCOMPOSITE CORKSCREW FT SUTURE ANCHOR BROKE DURING USE. THE PATIENT WAS NOT HARMED AS A RESULT OF ANCHOR BREAKAGE. THIS WAS DISCOVERED DURING A PROCEDURE, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED. ADDITIONAL INFORMATION RECEIVED ON 1/28/2025: UPON INSERTION OF THE BIOCOMPOSITE CORKSCREW, THE ANCHORS BROKE. ALL THE BROKEN FRAGMENTS WERE REMOVED FROM THE PATIENT. THE CASE WAS COMPLETE USING ANOTHER R-1927BCF BIOCOMPOSITE CORKSCREW. THE CASE WAS NOT DELAYED, AND ADDITIONAL ANESTHESIA WAS NOT NEEDED. THIS WAS DISCOVERED DURING AN RCR PROCEDURE ON (B)(6) 2025.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21333007 ↗
• MalfunctionNov 27, 2024Break; Break

  ON (B)(6) 2024, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA (B)(4) THAT AN AR-1927BCF SUTURE ANCHOR CRUMBLED AND BROKE WHEN BEING INSERTED. THIS OCCURRED DURING USE. ADDITIONAL INFORMATION REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20791274 ↗
• MalfunctionNov 14, 2024Break; Break

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR SURGERY THE ANCHOR BROKE DIRECTLY IN THE SOCKET. THE BROKEN PIECES WAS RETRIEVED OUT OF 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 20684392 ↗
• MalfunctionOct 8, 2024Break; Break

  ON (B)(6) 2024, IT WAS REPORTED BY A ARTHREX EMPLOYEE VIA EMAIL THAT A AR-1927BCF BIOCOMPOSITE CORKSCREW ANCHOR BROKE DURING INSERTION. THIS HAPPENED DURING A ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2024 WHEN A AR-1927PTB-45 WAS USED TO PREPARE THE BONE SOCKET AND THE ANCHOR BROKE DURING INSERTION. ALL THE FRAGMENTS WERE RETRIEVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING ANOTHER AR-1927BCF. NO PATIENT HARM AND NO SECONDARY PROCEDURE WAS NEEDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20397735 ↗
• MalfunctionSep 17, 2024Break; Break

  IT WAS REPORTED THAT DURING A SHOULDER SURGERY THE HOLE WAS PUNCHED, AND THE SURGEON BEGAN INSERTING THE ANCHOR INTO THE BONE. ABOUT A THIRD OF THE WAY IN THE PLASTIC SCREW BROKE. THE SURGEON REMOVED THE REST OF THE INSERTER FROM THE BODY.THE ANCHOR WAS INSIDE THE BONE BUT NOT FULLY INSERTED. MOST OF THE PLASTIC SCREW CAME OUT AND THE SUTURES REMAINED. THE SURGEON THEN CUT THE SUTURES AND USED VARIOUS DEVISES TO PULL OUT THE ANCHOR. THE SURGEON THEN PUSHED THE REMAINING FRAGMENTS OF TE ANCHOR FURTHER INTO THE BONE HOLE WITH THE PUNCH AND TAPPER. HE THEN ENTERED A NEW ANCHOR, AND PROCEEDED TO FINISH THE SURGERY SUCCESSFULLY. 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 20236561 ↗
• MalfunctionJun 27, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC KNEE SURGERY BOTH ANCHORS BROKE INSIDE THE PATIENT DURING INSERTION. IT WAS POSSIBLE TO RETRIEVE THE BROKEN PIECES FROM 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. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19623773 ↗
• MalfunctionMar 28, 2024Break; Break

  IT WAS REPORTED THAT DURING A ROTATOR CUFF SURGERY THE TIP OF THE ANCHOR BROKE OFF BEFORE INSERTION. IT BROKE OUTSIDE THE 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 18991182 ↗
• InjuryMar 7, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT SUFFERED FROM AN OSTEOLYSIS AFTER THE USAGE OF AN ARTHREX BIOCOMPOSITE SCREW. NO FURTHER INFORMATION RECEIVED. *** UPDATE DW 26-FEB-2024: FURTHER INFORMATION WAS PROVIDED THAT THE FIRST ARTHREX EMPLOYEE WAS MADE AWARE OF THIS ISSUE ON 22ND JUNE 2023. THE INITIAL SURGERY WAS PERFORMED ON (B)(6) 2020 WITH AN AR-2323BCC AND AR-1927BCF. THE PATIENT RETURNED DUE TO PAIN FOR A MRI IN (B)(6) 2023. *** UPDATE DW 28-FEB-2024: FURTHER INFORMATION WERE PROVIDED THAT NO FURTHER TREATMENT WAS PERFORMED DUE TO THIS ISSUE.

  Patient problems: Osteolysis

  MAUDE report 18856245 ↗
• MalfunctionJan 11, 2024Break; Break

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY THE CORKSCREW ANCHOR BROKE WHEN IT WAS SCREWED INTO THE PATIENT. THE BROKEN PIECES WERE RETRIEVED FROM 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 18497845 ↗
• MalfunctionNov 29, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON 11/06/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-1927BCF SUTURE ANCHOR BACKED OUT. THIS OCCURRED DURING A CASE WHERE THE DEVICE WAS INSERTED INTO THE PATIENT'S BONE AND CAME OUT. THE CASE WAS COMPLETED USING ANOTHER DEVICE.

  Patient problems: Insufficient Information

  MAUDE report 18229313 ↗
• MalfunctionOct 27, 2023Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC KNEE SURGERY BOTH ANCHORS BROKE INSIDE THE PATIENT DURING INSERTION. IT WAS POSSIBLE TO RETRIEVE THE BROKEN PIECES FROM 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. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18022884 ↗
• MalfunctionSep 1, 2023Break; Break

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY THE FUNCTION OF THE DEVICE DIDN`T RELEASE AFTER THREE TURNS. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. NO FURTHER INFORMATION RECEIVED. UPDATE AVOE 15-MAR-2023: FURTHER INFORMATION WAS PROVIDED THAT NO PART OF THE DEVICE BROKE OFF. 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 30-AUG-2023: IT WAS CONFIRMED THAT THE SURGEON TURNED THE DEVICE TWICE AND ON THE THIRD TURN CAME THE CRACK AND THE BREAK. EVERYTHING WAS REMOVED FROM THE PATIENT AND THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER.

  Patient problems: Failure of Implant

  MAUDE report 17671162 ↗
• MalfunctionMay 11, 2023Break; Break

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY THE ANCHOR OF THE DEVICE BROKE OFF AFTER THE SECOND ROTATION INSIDE THE PATIENT. 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: Failure of Implant; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16914547 ↗
• MalfunctionMar 23, 2023Break; Break

  ADDITIONAL INFORMATION RECEIVED ON 3/9/2023: SURGEON WAS ATTEMPTING TO INSERT THE AR-1927BCF-45 BIOCOMPOSITE-CORKSCREW FT WHEN THE SCREW BROKE INSIDE THE PATIENT. THEN, AN AR-1927BCF BIOCOMPOSITE CORKSCREW FT WAS OPEN; HOWEVER, THIS ONE ALSO BROKE WHILE TRYING TO IMPLANT. ALL THE SUTURES FROM BOTH ANCHORS WERE RETRIEVED, BUT THE BORKEN FRAGMENS REMAIN IN THE PATIENT. THIS WAS DISCOVERED DURING A KNEE QUADRICEPS INJURY PROCEDURE AND COMPLETED USING AN AR-1927BCF BIOCOMPOSITE CORKSCREW FT IN A NEW BONE SOCKET.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Foreign Body In Patient

  MAUDE report 16597255 ↗
• MalfunctionJan 3, 2023Break

  IT WAS REPORTED THAT DURING A TENDON REFIXATION SURGERY THE ANCHOR BROKE OFF IN THE HOLE. 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: Foreign Body In Patient

  MAUDE report 16087124 ↗
• MalfunctionOct 24, 2022Break

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY THE IMPLANT BROKE. 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 15657586 ↗
• MalfunctionSep 26, 2022Break

  ON (B)(6) 2022, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA SEMS THAT AN AR-1927BCF SUTURE ANCHOR BROKE BEFORE IT WAS FULLY SEATED. THIS WAS DISCOVERED DURING A CASE AND BROKE INSIDE THE JOINT.

  Patient problems: Insufficient Information

  MAUDE report 15484172 ↗