Arthrex® AR-1927BCT-475-1Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00888867237865), received between Jan 11, 2022 and Jun 2, 2026 — classified as 14 malfunctions.

The most frequently reported specific device problem is “Break” (13 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 2, 2026Break

  ON 14 MAY 2026, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-1927BCF-475, BC CORKSCREW FT TRI-PLAY 4.75MM WAS REPORTED TO HAVE THE ANCHOR SNAPPED WHEN BEING INSERTED. THIS OCCURRED ON (B)(6) 2026 DURING AN UNKNOWN PROCEDURE. THE CASE WAS COMPLETED SUCCESSFULLY.

  Patient problems: Insufficient Information

  MAUDE report 25360628 ↗
• MalfunctionJan 8, 2026Break

  IT WAS REPORTED THAT DURING A SHOULDER SURGERY THE ANCHOR BROKE DURING INSERTION. 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 24005311 ↗
• MalfunctionOct 17, 2025Break; Break

  IT WAS REPORTED THAT DURING A ROTATOR CUFF SURGERY THE ANCHOR BROKE. ALL PARTS WERE RETRIEVED. 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 23323300 ↗
• MalfunctionApr 18, 2025Break; Break

  IT WAS REPORTED THAT DURING A ROTATOR CUFF SURGERY THE SCREW BROKE DURING INSERTION. 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 21867716 ↗
• MalfunctionJan 7, 2025Break; Break

  IT WAS REPORTED THAT DURING A SHOULDER SURGERY THE DEVICE WAS COMPLETELY CRUSHED AND SHATTERED DURING INSTALLATION. THE SURGEON HAD TO RETRIEVE THE PIECES OF BIOCOMPOSITE FROM THE BONE AND JOINT. ALL FRAGMENTS WERE RETRIEVED. 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 21095339 ↗
• MalfunctionSep 24, 2024Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC KNEE SURGERY THE ANCHOR COULD NOT BE SCREWED IN TIGHTLY. THE ANCHOR DID NOT HOLD. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE PART NUMBER AR-2324BCC. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20292279 ↗
• MalfunctionSep 3, 2024Break; Break

  ON 08 AUGUST 2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-1927BCT-475-1 CORKSCREW FT, BC, SUTURETAPE, 4.75MM WAS REPORTED TO HAVE BROKEN WHILE BEING INSERTED. THIS OCCURRED ON (B)(6) 2024 IN (B)(6) HOSPITAL DURING A ROTATOR CUFF REPAIR. THE CASE WAS COMPLETED SUCCESSFULLY. THE TAPES WERE PULLED OUT, BROKEN PIECES REMOVED AND REPLACED A PEEK 4.75 CORKSCREW THERE WAS CASE INVOLVEMENT.

  Patient problems: Insufficient Information

  MAUDE report 20126938 ↗
• MalfunctionJul 1, 2024Break; Break

  IT WAS REPORTED THAT DURING A RECTUS TENDON REFIXATION ON THE RIGHT PELVIS THE CORKSCREW BROKE. ALL PARTS WERE RETRIEVED FROM THE PATIENT. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A DEVICE FROM ANOTHER MANUFACTURER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19644425 ↗
• MalfunctionJul 1, 2024Break; Break

  IT WAS REPORTED THAT DURING A RECTUS TENDON REFIXATION ON THE RIGHT PELVIS THE CORKSCREW BROKE. ALL PARTS WERE RETRIEVED FROM THE PATIENT. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A DEVICE FROM ANOTHER MANUFACTURER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19644364 ↗
• MalfunctionAug 31, 2023Break; Break

  IT WAS REPORTED THAT DURING A SHOULDER SURGERY THE ANCHOR FRACTURED WHILE SCREWING THE ANCHOR INTO THE BONE. 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 17662374 ↗
• MalfunctionDec 27, 2022Break

  IT WAS REPORTED THAT DURING A SHOULDER SURGERY THE DEVICE BROKE AT THE MOMENT OF TYING THE KNOTS IN FULL THREAD WITH A KNOT PUSHER. THE BROKEN OFF PART WAS RETRIEVED FROM THE PATIENT. THE REST OF THE DEVICE REMAINED INSIDE THE PATIENT AND WAS USED TO FINISH THE PROCEDURE. ACCORDING TO THE SURGEON NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY OCCURRED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH THE SAME DEVICE. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY. UPDATE AVOE 12-DEC-2022: IT WAS CONFIRMED THAT THE DEVICE DID BREAK WHEN THE THREADS WERE TIED. ALL FRAGMENTS WERE REMOVED. THE SURGEON DID NOT USE ANOTHER DEVICE TO COMPLETE THE PROCEDURE. HE KEPT THE SAME IMPLANT BY BALANCING THE STRANDS. THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16051687 ↗
• MalfunctionJan 31, 2022Break

  IT WAS REPORTED THAT DURING A BICEPS TENODESIS SURGERY THE DEVICE BROKE OFF IN THE MIDDLE DURING INSERTION AND COULD NO LONGER BE USED. 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 13397211 ↗
• MalfunctionJan 31, 2022Break

  IT WAS REPORTED THAT DURING A ROTATOR CUFF SURGERY AFTER DRILLING WITH THE NEEDLE BOTH USED ANCHORS BROKE OFF. NO DEBRIS OR FRAGMENTS REMAINED INSIDE THE PATIENT AND EVERY FRAGMENT WAS RETRIEVED OUT OF THE PATIENT. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. THE SURGERY WAS FINISHED SUCCESSFULLY. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY. 12-JAN-2022 UPDATE: FURTHER INFORMATION WERE PROVIDED THAT THE FIRST BROKEN ANCHOR WAS RETRIEVED OUT OF THE PATIENT AND A PART OF THE SECOND IMPLANT WHICH BROKE REMAINED INSIDE THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13394032 ↗
• MalfunctionJan 11, 2022Break

  IT WAS REPORTED THAT DURING A ROTATOR CUFF SURGERY THE ANCHOR BROKE OFF INSIDE THE PATIENT WHEN SCREWING INTO THE HUMERUS TO FIX THE CAP REPAIR ASSEMBLIES, DESPITE OF USING THE DEDICATED TAPPING NEEDLE. NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY WAS 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. UPDATE SWIT 27-DEC-2021: THE BROKEN PIECE WAS RETRIEVED FROM PATIENT. THE ANCHOR BROKE AFTER FULL INSERTION TO INTENDED DEPTH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13225926 ↗