Arthrex® AR-1927BCFTRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00888867023390), received between Nov 2, 2017 and Jul 27, 2026 — classified as 1 injury, 6 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 27, 2026Fracture

  Patient problems: Foreign Body In Patient

  MAUDE report 50042831 ↗
• MalfunctionAug 25, 2025Break; Fracture; Break; Fracture

  ON 8/4/2025, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA EMAIL THAT AN AR-1927BCFT BIOCOMPOSITE CORKSCREW FRACTURED. DURING THE PROCEDURE, STANDARD PROTOCOL WAS FOLLOWED: AFTER ESTABLISHING THE VISION PORTALS, PLACEMENT OF THE 5.5 MM IMPLANT WAS INITIATED. THE STARTER PUNCH WAS PASSED AND HAMMERED UNTIL THE FIRST LASER LINE MARKED ¿FT¿ WAS REACHED. UPON PLACEMENT AND TWO TURNS OF THE IMPLANT, FRACTURE OF THE SCREW WAS OBSERVED. ATTEMPTS WERE MADE TO EITHER COMPLETE INSERTION OR RETRIEVE THE TIP OF THE SCREW; HOWEVER, THE FRACTURE PREVENTED FURTHER MOVEMENT IN ANY DIRECTION. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2025. ADDITIONAL INFORMATION WAS RECEIVED ON 08/13/2025: ALL SCREW FRAGMENTS WERE RETRIEVED. NO DOCUMENTATION WAS AVAILABLE REGARDING THE CASE COMPLETION DETAILS OR THE PART NUMBER USED. ADDITIONALLY, THERE WAS NO INFORMATION INDICATING ANY PROCEDURAL DELAY OR ADMINISTRATION OF ADDITIONAL ANESTHESIA.

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

  MAUDE report 22883425 ↗
• MalfunctionApr 17, 2025Positioning Failure; Failure to Advance; Positioning Failure; Failure to Advance

  IT WAS REPORTED THAT DURING A ROTATOR CUFF SURGERY THE DEVICE COULD NOT BE SCREWED INTO 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 21859118 ↗
• MalfunctionMay 3, 2022Break

  ON (B)(6) 2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AR-1927BCFT BIO-COMPOSITE CORKSCREW BROKE DURING INSERTION. SURGEON REMOVED ALL BROKEN FRAGMENTS AND USED ANOTHER BIO-COMPOSITE CORKSCREW TO COMPLETE THE CASE. THIS WAS DISCOVERED DURING AN RCR ON (B)(6) 2022.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14270383 ↗
• MalfunctionMar 30, 2021Break

  IT WAS REPORTED DURING A ROTATOR CUFF REPAIR PROCEDURE THE AR-1927BCFT ANCHOR BROKE UPON INSERTION. A PORTION OF THE IMPLANT REMAINS IMPLANTED WITHIN THE PATIENT. THE REP REPORTED THE CASE WAS COMPLETED, AND THERE IS NO NEED FOR A SECOND SURGERY. A 5.5 PUNCH WAS USED TO PREPARE THE BONE.

  Patient problems: Failure of Implant

  MAUDE report 11588074 ↗
• MalfunctionMar 1, 2021Break

  IT WAS REPORTED DURING A ROTATOR CUFF REPAIR PROCEDURE THE SURGEON USED A 5.5 PUNCH TO MAKE A HOLE IN THE HUMERUS, THEN UPON IMPACTION/INSERTION OF THE AR-1927BCFT 5.5 CORKSCREW, THE ANCHOR BROKE. PART OF IMPLANT REMAINS IN PATIENT. THE CASE WAS COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11393440 ↗
• InjuryNov 2, 2017Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A ROTATOR CUFF REPAIR PROCEDURE WITH 5-6 ANCHORS INTO HER SHOULDER. THE PATIENT STATES THAT THE SHE BEGAN TO EXPERIENCE HEAT IN HER SHOULDER AND THE ANCHORS HAVE EATEN AWAY AT HER TISSUE/MUSCLE. THE ANCHORS HAVE SINCE BEEN REMOVED IN A REVISION SURGERY. NO CASE INFORMATION AND NO FURTHER DETAILS WERE PROVIDED AT THE TIME OF INITIAL REPORT. THE FOLLOWING INFORMATION WAS OBTAINED FROM PATIENT MEDICAL RECORDS: ORIGINAL ROTATOR CUFF SURGERY WAS (B)(6) 2014. REVISION SURGERY WAS (B)(6) 2015. ROTATOR CUFF REPAIR IMPLANT LOG-DATED (B)(6) 2014: PARTS USED DURING PROCEDURE: AR-1927BCFT, LOT 1190433, QTY 3 ((B)(4)) AR-1922BC, LOT 1183470, QTY 2 ((B)(4)) OPERATIVE REPORT DATED (B)(6) 2014: HEMOSTASIS WAS OBTAINED WITH ELECTRO-CAUTERY. THE OPERATIVE ASSISTANT FACILITATED THE ALTERNATING USE OF THE SHAVER AND THE ELECTROCAUTERY. PHYSICIAN OFFICE RECORDS DATED (B)(6) 2015: PATIENT REPORTED STILL HAVING SOME TROUBLE WITH LIFTING HER ARM ABOVE HER SHOULDER. PHYSICIAN OFFICE RECORDS DATED (B)(6) 2015 PATIENT REPORTED HAVING ISSUES WITH WEAKNESS, STILL SOME SORENESS BUT NOT AS BAD. AND DIFFICULTY LIFTING HER ARM. PHYSICIAN OFFICE RECORDS DATED (B)(6) 2015:

  Patient problems: Loss of Range of Motion; Necrosis; Perforation; Tissue Damage

  MAUDE report 6996484 ↗