Arthrex® AR-1927BCFT-45Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00888867096844), received between Oct 23, 2020 and Feb 10, 2025 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Break” (5 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 10, 2025Break; Break

  ON (B)(6) 2025, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT FOR AN AR-1927BCFT-45, 4.5 BIOCOMPOSITE FT WITH TIGERTAIL THE IMPLANT BROKE. THIS WAS DETECTED DURING A LEFT SHOULDER ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2025. THE IMPLANT BROKE AS SURGEON WAS LIGHTLY GRAZING THE ANCHOR ON BONE SURFACE TO LOOK FOR THE HOLE. PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO PATIENT HARM. THE BROKEN IMPLANT WAS REMOVED FROM THE OPERATION SITE FULLY INTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21346176 ↗
• MalfunctionFeb 10, 2025Break; Break

  ON 28TH JANUARY 2025, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT FOR AN AR-1927BCFT-45, 4.5 BIOCOMPOSITE FT WITH TIGERTAIL THE IMPLANT BROKE. THIS WAS DETECTED DURING A LEFT SHOULDER ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2025. THE IMPLANT BROKE AS SURGEON WAS LIGHTLY GRAZING THE ANCHOR ON BONE SURFACE TO LOOK FOR THE HOLE. PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO PATIENT HARM. THE BROKEN IMPLANT WAS REMOVED FROM THE OPERATION SITE FULLY INTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21346107 ↗
• MalfunctionFeb 3, 2025Break; Crack; Break; Crack

  IT WAS REPORTED THAT DURING A ROTATOR CUFF SURGERY THE DEVICE CRACKED. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. NO FURTHER INFORMATION RECEIVED. UPDATE AVOE 22-JAN-2025: IT WAS CONFIRMED THAT THE ERROR OCCURRED DURING A SINGLE MEDIAL ROW ROTATOR CUFF REPAIR. 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 21294799 ↗
• MalfunctionFeb 3, 2025Break; Crack; Break; Crack

  IT WAS REPORTED THAT DURING A ROTATOR CUFF SURGERY THE DEVICE CRACKED. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. NO FURTHER INFORMATION RECEIVED. UPDATE AVOE 22-JAN-2025. IT WAS CONFIRMED THAT THE ERROR OCCURRED DURING A SINGLE MEDIAL ROW ROTATOR CUFF REPAIR. 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 21294772 ↗
• InjuryOct 23, 2020Break

  IT WAS REPORTED THAT DURING A REMPLISSAGE PROCEDURE THE AR-1927BCFT-45 (BIOCOMPOSITE FT WITH TIGERTAIL) WAS PLACED. WHEN THE SURGEON PULLED ON THE SUTURES TO TEST IT'S INTEGRITY THE EYELET BROKE AND THE REPAIR SUTURES BECAME UNUSABLE. THE SURGEON RAN OUT OF BONE AND THE CHOSE TO BAIL ON THE REMPLISSAGE. THE ANCHOR BODY REMAINED IN THE PATIENT. ADDITIONAL INFORMATION OBTAINED 10/8/2020: PATIENT BONE QUALITY IS REPORTED TO HAVE BEEN POOR. THE BONE HAD BEEN PREPARED WITH THE 3.5 PUSHLOCK PUNCH FOR THE 4.5 CORKSCREW. THE ANCHOR BODY WAS LEFT IN THE PATIENT. ALL FOUR SUTURE TAILS HAD BEEN PULLED ON TO TEST HE STRENGTH OF THE ANCHOR AND THE SULTURES PULLED OUT OF THE ANCHOR. REP WHO WAS PRESENT BELIEVES THE EYELET MAY HAVE BROKE. REP STATES THE EYELET IS NOT FLOATING OR IN THE PATIENT BUT IS UNSURE WHERE THE SUTURE EYELET IS. SUTURES WERE REMOVED AND DISCARDED AFTER THE CASE WAS OVER. A KNOTLESS SUTURETAK PULLED OUT OF THE BONE PRIOR TO THE CORKSCREW BEING INSERTED. THE SUTURETAK PULLING OUT IS REPORTED TO HAVE BEEN THE RESULT OF THE POOR BONE QUALITY AND, PER THE REP WHO WAS PRESENT, THE SURGEON BEING OVER ZEALOUS WITH HIS TUGS. THE SUTURETAK ANCHOR ITSELF HAD NO ISSUES. SINCE THE CORKS

  Patient problems: Foreign Body In Patient

  MAUDE report 10730344 ↗