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

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 00888867096783), received between May 23, 2019 and Aug 26, 2026 — classified as 3 injuries, 21 malfunctions.

The most frequently reported specific device problem is “Break” (21 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 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 26, 2026Fracture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50453792 ↗
• MalfunctionJun 18, 2026Failure to Advance

  IT WAS REPORTED THAT DURING A SURGERY THE DEVICE COULD NOT BE INSERTED. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. NO FURTHER INFORMATION RECEIVED. UPDATE 02-JUN-2026: FURTHER INFORMATION WAS PROVIED THAT THE SUTURE DIDN'T GO THROUGH THE ANCHOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25548240 ↗
• MalfunctionFeb 9, 2026Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC SHOULDER SURGERY THE TWO ANCHORS BROKE OFF WHEN SCREWED IN, EVEN THOUGH THEY HAD BEEN PRE-DRILLED AND PRE-CUT WITH A THREAD CUTTER. THE BROKEN PARTS 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 24291036 ↗
• MalfunctionFeb 9, 2026Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC SHOULDER SURGERY THE TWO ANCHORS BROKE OFF WHEN SCREWED IN, EVEN THOUGH THEY HAD BEEN PRE-DRILLED AND PRE-CUT WITH A THREAD CUTTER. THE BROKEN PARTS 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 24290618 ↗
• MalfunctionJan 5, 2026Break; Positioning Failure

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR SURGERY THE SUTURE DID NOT SLIDE PROPERLY. 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. UPDATE 16-DEC-2025: IT WAS FURTHER NOTED DURING THE DEVICE INVESTIGATION THAT THE ANCHOR BROKE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23957934 ↗
• MalfunctionJun 19, 2025Break; Break

  IT WAS REPORTED THAT DURING A SHOULDER SURGERY THE ANCHOR 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 22292423 ↗
• MalfunctionMay 23, 2025Break; Break

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY THE FRONT PART OF THE THREE ANCHORS AR-1927BCF-1 (LOT: 15298095) BROKE OFF WITHIN ONE SURGERY DURING INSERTION. ALL FRAGMENTS WERE REMOVED AND NOTHING REMAINED IN 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 22077544 ↗
• MalfunctionMay 23, 2025Break; Break

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY THE FRONT PART OF THE THREE ANCHORS AR-1927BCF-1 (LOT: 15298095) BROKE OFF WITHIN ONE SURGERY DURING INSERTION. ALL FRAGMENTS WERE REMOVED AND NOTHING REMAINED IN 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 22077407 ↗
• MalfunctionMay 22, 2025Break; Break

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY THE FRONT PART OF THE THREE ANCHORS AR-1927BCF-1 (LOT: 15298095) BROKE OFF WITHIN ONE SURGERY DURING INSERTION. ALL FRAGMENTS WERE REMOVED AND NOTHING REMAINED IN 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 22075098 ↗
• MalfunctionMar 14, 2025Break; Break

  IT WAS REPORTED THAT DURING A ROTATOR CUFF 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 21607113 ↗
• MalfunctionMar 13, 2025Break; Break

  IT WAS REPORTED THAT DURING A ROTATOR CUFF 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 21593672 ↗
• MalfunctionAug 6, 2024Break; Break

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR SURGERY THE CORKSCREW ANCHOR BROKE DURING INSERTION. 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 19918897 ↗
• MalfunctionMay 23, 2024Break; Break

  IT WAS REPORTED THAT DURING A ROTATOR CUFF SURGERY THE CORKSCREW BROKE DURING SCREWING IN. 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 19387627 ↗
• MalfunctionApr 12, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY SURGERY OF THE SHOULDER JOINT WITH THE REMPLISSAGE METHOD THE IMPLANT BROKE WHILE BEING SCREWED INTO A PRE-DRILLED HOLE. 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 19095330 ↗
• MalfunctionMar 27, 2023Break; Break

  IT WAS REPORTED THAT DURING A KNEE SURGERY WHEN INSERTING THE ANCHOR THE SCREW BROKE. ALL FRAGMENTS WERE RETRIEVED. ACCORDING TO THE SURGEON, NO HARM TO THE 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: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16618687 ↗
• MalfunctionMar 15, 2023Break; Break

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY, THE CORKSCREW BROKE OFF. THERE WAS NO HARM TO THE 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. UPDATE (B)(6) 2023. NEN: FURTHER INFORMATION REVEALED THAT THE BROKEN PIECES WERE RETRIEVED FROM THE PATIENT. THE SURGERY WAS FINISHED WITHOUT ANY ISSUES.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 16544280 ↗
• MalfunctionMar 6, 2023Break; Break

  IT WAS REPORTED THAT DURING A ROTATOR CUFF SUTURE SURGERY, THE ANCHOR BROKE OFF. THE BROKEN PIECE WAS RETRIEVED FROM THE PATIENT. THERE WAS NO HARM TO THE 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: Failure of Implant; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16485070 ↗
• MalfunctionNov 11, 2021Break; Difficult to Remove

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC RECONSTRUCTION OF THE SUPRASPINATUS TENDON THE DEVICE BROKE DURING IMPLANTATION. THE TIP FOR THE DEVICE 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: Foreign Body In Patient

  MAUDE report 12793563 ↗
• MalfunctionAug 3, 2021Break

  IT WAS REPORTED THAT DURING ROTATOR CUFF SUTURE SURGERY THE DEVICES BROKE OFF WHILE INSERTING INTO THE PATIENT. THE BROKEN OFF PIECES HAVE BEEN RETRIEVED 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 RECEIVED.

  Patient problems: Insufficient Information

  MAUDE report 12268422 ↗
• MalfunctionAug 3, 2021Break

  IT WAS REPORTED THAT DURING ROTATOR CUFF SUTURE SURGERY THE DEVICES BROKE OFF WHILE INSERTING INTO THE PATIENT. THE BROKEN OFF PIECES HAVE BEEN RETRIEVED 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 RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12268407 ↗
• MalfunctionJun 3, 2021Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REFIXATION THREE DEVICES FAILED. THE SUTURES COULD NOT BE RELEASED. 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. UPDATE (B)(6) 2021 FURTHER INFORMATION WERE PROVIDED THAT THREE IMPLANTS WERE PARTIALLY IMPLANTED AND THEN THE SUTURES BECAME DETACHED. THEREFORE ALL IMPLANTS HAD TO BE RETRIEVED AND WITH THE 4TH IMPLANT THE CASE COULD BE COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11931130 ↗
• InjuryNov 7, 2019Break

  IT WAS REPORTED THAT DURING AN SHOULDER LIGAMENTOPLASTY THE ARTHREX ANCHOR AR-1927BCF-1 BROKE INSIDE THE PATIENTS SHOULDER. ACCORDING TO THE SURGEON THE BROKEN FRAGMENT REMAINED INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO FURTHER INFORMATION AT THE MOMENT. UPDATE (B)(6) 2019: THE SURGERY WAS COMPLETED SUCCESSFULLY WITH A NEW DEVICE OF THE SAME PART NUMBER. THERE WAS NO SECOND SURGERY NECESSARY.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 9289854 ↗
• InjuryOct 15, 2019Break

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY, WHILE THE DEVICE WAS INSERTED, THE ANCHOR BROKE IN HALF. THE HALF BROKEN ANCHOR REMAINED INSIDE THE PATIENT. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH A NEW DEVICE OF THE SAME PART NUMBER. THE OTHER HALF OF THE BROKEN SCREW WILL NOT BE SENT IN FOR EVALUATION BECAUSE IT WAS DISCARDED BY THE FACILITY. THE DRIVER WILL BE SENT BACK FOR EVALUATION. NO FURTHER INFORMATION RECEIVED. UPDATE 01-OCT-2019: THE BROKEN FRAGMENT OF THE SCREW IS WELL FIXED INTO THE BONE AND CANNOT MOVE. A NEW DRILL HOLE WAS NECESSARY TO PLACE THE NEW SCREW NEXT TO THE BROKEN SCREW. THE SURGERY WAS PERFORMED ON (B)(6) 2019.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 9193159 ↗
• InjuryMay 23, 2019Break

  IT WAS REPORTED THAT A SHOULDER ARTHROSCOPY TOOK PLACE. THE ARTHREX DEVICE AR-1927BCF-1 WAS USED WHICH BROKE DURING INSERTION. THE SURGEON DECIDED THAT THE ANCHOR IS STABLE ENOUGH SO THERE IS NO NEED TO REMOVE THE ANCHOR OR USE A SECOND DEVICE. THE BROKEN FRAGMENT OF THE ANCHOR WAS COMPLETELY REMOVED. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH THIS DEVICE. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8637231 ↗