Arthrex® AR-1927BCF-3-1Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00888867096790), received between May 10, 2021 and Feb 24, 2025 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Break” (6 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 24, 2025Break; Break

  ON (B)(6) 2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-1927BCF-3-1 SUTURE ANCHOR, BIOCOMPOSITE CORKSCREW WAS REPORTED TO HAVE FAILED DURING USE. THIS OCCURRED ON (B)(6) 2025 IN ROYSTON HOSPITAL DURING AN ARTHROSCOPIC ROTATOR CUFF REPAIR. IT WAS REPORTED THAT A 5.5 CORKSCREW WAS IMPLANTED BUT THE INCORRECT PUNCH WAS USED TO PREPARE THE BONE PRIOR. THE TIP OF THE CORKSCREW CAME AWAY AND REMAINS WITHIN THE PATIENT. THE CASE WAS COMPLETED SUCCESSFULLY USING ANOTHER ANCHOR. THERE WAS CASE INVOLVEMENT.

  Patient problems: Foreign Body In Patient; Insufficient Information

  MAUDE report 21445852 ↗
• MalfunctionOct 25, 2024Break; Break

  IT WAS REPORTED THAT DURING A ROTATOR CUFF SURGERY THE ANCHOR BROKE IN HALF. 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 20538689 ↗
• MalfunctionJul 11, 2022Break

  IT WAS REPORTED THAT DURING A ROTATOR CUFF SURGERY THE ANCHOR OF THE DEVICE BROKE. ALL BROKEN PARTS WERE RETRIEVED FROM THE PATIENT. THIS RESULTED IN A PROLONGED SURGERY TIME. 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: Insufficient Information

  MAUDE report 14976107 ↗
• MalfunctionNov 2, 2021Entrapment of Device; Material Separation

  IT WAS REPORTED THAT DURING A ROTATOR CUFF SURGERY THE DEVICE BROKE INSIDE THE PATIENT. THE BROKEN PIECE WASN`T 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: Foreign Body In Patient

  MAUDE report 12737955 ↗
• MalfunctionSep 14, 2021Break; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING A SURGERY THE ANCHOR BROKE OFF INSIDE THE PATIENT WHEN SCREWING IN THE HUMERUS TO SECURE THE SUTURES OF THE CAP REPAIR ASSEMBLY. 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.

  Patient problems: Foreign Body In Patient

  MAUDE report 12467461 ↗
• MalfunctionMay 10, 2021Break

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY FOR A ROTATOR CUFF SUTURE THE METAL IMPLANT HOLDER OF THE DEVICE BROKE IN THE HUMERAL HEAD WHEN THE SURGEON TRIED TO SCREW IT IN. THE ANCHOR HOLE HAD TO BE ENLARGED TO REMOVE THE DEVICE. ALL BROKEN PIECES 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 11798802 ↗
• MalfunctionMay 10, 2021Break; Crack

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY FOR A ROTATOR CUFF SUTURE TWO DEVICES WERE TESTED WHICH CRACKED DURING INSERTION. ALL BROKEN PIECES 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 11798798 ↗