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

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 00888867264595), received between Jan 18, 2021 and Sep 9, 2026 — classified as 1 injury, 22 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 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 9, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50694995 ↗
• MalfunctionSep 9, 2026Break

  It was reported that during a rotator cuff repair surgery the anchor broke while inserting the device with the punch. 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 50694840 ↗
• MalfunctionAug 5, 2026Break

  Patient problems: Foreign Body In Patient

  MAUDE report 50140446 ↗
• MalfunctionAug 5, 2026Break

  Patient problems: Foreign Body In Patient; Insufficient Information

  MAUDE report 50140443 ↗
• MalfunctionFeb 10, 2026Break

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR SURGERY THE CORCKSCREW BROKE. ALL 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 24305556 ↗
• MalfunctionFeb 10, 2026Break

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR SURGERY THE CORCKSCREW 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. UPDATE ON 28-JAN-26: FURTHER INFORMATION WAS RECEIVED THAT ALL BROKEN PARTS WERE RETRIEVED FROM THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24305262 ↗
• MalfunctionDec 4, 2025Break; Break

  IT WAS REPORTED THAT DURING A SHOULDER SURGERY WHILE THE SURGEON INSERTED THE ANCHOR THE ANCHOR BROKE. AS THE TIP OF THE DEVICE WAS ALREADY IN PLACE THE SURGEON DECIDED THAT THIS IS ENOUGH FOR THE FIXATION. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23714305 ↗
• MalfunctionApr 2, 2025Failure to Advance; Failure to Advance

  IT WAS REPORTED THAT DURING A ROTATOR CUFF SURGERY THE EYELET IS STICKING OUT OF THE ANCHOR. 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 21753148 ↗
• MalfunctionMar 20, 2025Failure to Advance; Failure to Advance

  IT WAS REPORTED THAT DURING A SHOULDER SURGERY THE WHITE EYELET PROTRUDES FROM THE ANCHOR. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH THE SAME 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 21651603 ↗
• MalfunctionMar 19, 2025Material Protrusion/Extrusion; Material Protrusion/Extrusion

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC SHOULDER SURGERY THE SUTURE PROTRUDED FROM THE ANCHOR. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH THE SAME 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 21643123 ↗
• MalfunctionMar 18, 2025Break; Break

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY THE ANCHOR OF THE FIRST ROW BROKE OFF WHEN SCREWED IN. THE TIP OF THE ANCHOR BROKE OFF INSIDE THE PATIENT'S JOINT AND WAS REMOVED. 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 21632879 ↗
• MalfunctionFeb 24, 2025Material Protrusion/Extrusion; Material Protrusion/Extrusion

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC SHOULDER SURGERY THE WHITE EYELET PROTRUDED FROM THE ANCHOR. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH THE SAME DEVICE. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: Foreign Body In Patient

  MAUDE report 21447948 ↗
• MalfunctionFeb 6, 2025Break; Break

  IT WAS REPORTED THAT DURING A ROTATOR CUFF SURGERY THE CORKSCREW 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 21320840 ↗
• MalfunctionFeb 4, 2025Failure to Advance; Failure to Advance

  IT WAS REPORTED THAT DURING A SHOULDER SURGERY THE EYE OF THE DEVICE PROTRUDED FROM THE ANCHOR. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH THE SAME 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 21305291 ↗
• MalfunctionDec 31, 2024Material Protrusion/Extrusion; Material Protrusion/Extrusion

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR SURGERY THE EYE OF THE DEVICE PROTRUDED FROM THE ANCHOR AFTER THE DEVICE WAS IN PLACE. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH THE SAME DEVICE. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: Foreign Body In Patient

  MAUDE report 21048222 ↗
• MalfunctionDec 31, 2024Material Protrusion/Extrusion; Material Protrusion/Extrusion

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR SURGERY THE EYE OF THE DEVICE PROTRUDED FROM THE ANCHOR AFTER THE DEVICE WAS IN PLACE. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH THE SAME DEVICE. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: Foreign Body In Patient

  MAUDE report 21048072 ↗
• MalfunctionOct 4, 2024Break; Break

  IT WAS REPORTED THAT DURING A ROTATOR CUFF SURGERY THE SUTURE ANCHOR BROKE WHEN IT WAS IMPLANTED. THE BROKEN PIECE WAS RETRIEVED OUT OF 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 20369156 ↗
• MalfunctionJan 11, 2024Break; Break

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY THE ANCHOR BROKE OFF. THE BROKEN PIECES WERE RETRIEVED OUT OF 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18497478 ↗
• MalfunctionJan 11, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT DURING A SHOULDER SURGERY THE ANCHOR WAS FAULTY. 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 NROE 04-JAN-2024: FURTHER INFORMATION REVEALED THAT WHEN THE ANCHOR WAS IMPLANTED, THE SCREW THREAD CAME LOOSE WHEN IT WAS SCREWED IN THE BONE. THIS FAULTY DEVICE WAS COMPLETELY REMOVED AND REPLACED BY AN ANCHOR OF THE SAME TYPE. NO CONSEQUENCES FOR THE PATIENT, APART FROM A LOSS OF TIME AND THEREFORE A LONGER ANESTHESIA TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18496401 ↗
• InjuryJul 12, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT AFTER A ROTATOR CUFF REPAIR SURGERY THE PATIENT HAS AN INFECTION. DUE TO THE INFECTION THE IMPLANTED ITEMS WILL BE REMOVED IN REVISION SURGERY ON (B)(6)2023. THE FOLLOWING DEVICES WERE USED OR IMPLANTED IN THE INITIAL SURGERY: AR-6530-1 LOT 829187258, AR-13995N-1 LOT 15068024, AR-1927BCT-1 LOT 14146766, AR-2324BCM-1 LOT 15046069. UPDATE SWIT (B)(6)2023: THE INITIAL SURGERY WAS PERFORMED LAST WEEK. THE INFECTION WAS OBSERVED DURING THE WEEKEND ((B)(6)2023). THE INTERVENTION IS PLANNED FOR THE (B)(6)2023. THE SURGEON IS PLANNING TO REMOVE EVERYTHING WITHOUT REPLACING IMPLANTS. UPDATE SWIT (B)(6)2023: THE IMPLANTS WERE SUCCESSFULLY REMOVED DURING REVISION SURGERY. THEY ARE AWAITING THE RESULTS OF THE BACTERIOLOGICAL SAMPLE. THE PATIENT WILL RECEIVE AN ANTIBIOTIC THERAPY AND ONCE THE INFECTION HAS BEEN RESOLVED, HE WILL WEAR STOCKS.

  Patient problems: Unspecified Infection

  MAUDE report 17304402 ↗
• MalfunctionDec 1, 2022Break

  ON (B)(6) 2022, IT WAS REPORTED BY A SALES REP VIA EMAIL THAT A AR-1927BCT-1, 5.5MM BC CORKSCREW FT W/ SUTURETAPE ANCHOR SNAPPED UPON INSERTION. THIS WAS DISCOVERED DURING USE AND A CASE WAS INVOLVED. TO COMPLETE THE PROCEDURE, A COMPETITOR ANCHOR WAS OPENED/USED INSTEAD.

  Patient problems: Insufficient Information

  MAUDE report 15892910 ↗
• MalfunctionMay 23, 2022Break

  IT WAS REPORTED THAT DURING A ROTATOR CUFF MUSCLE REINSERTION PROCEDURE THE ANCHOR BROKE. THE SURGEON WAS ABLE TO RETRIEVE EVERYTHING OUT OF THE PATIENT. IT WAS FURTHER REPORTED THAT THE TRACTION WIRE CAME OFF THE ANCHOR WHEN THE SUTURE WAS TIGHTENED. ACCORDING TO THE SURGEON 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14469645 ↗
• MalfunctionJan 18, 2021Material Fragmentation

  IT WAS REPORTED THAT DURING SHOULDER ARTHROSCOPY THE SCREW OF THE AR-1927BCT-1 ANCHOR BROKE OFF INSIDE THE PATIENT DURING PLACEMENT. ONE PART REMAINS IN THE BONE AND THE OTHER WAS RECOVERED. 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: THE REMAINING PART IS FIXED WELL IN THE PATIENT. IT CAN´T MOVE. UPDATE (B)(6) 2021: A NEW HOLE WAS DRILLED TO USE A NEW DEVICE WITH THE SAME PART NUMBER.

  Patient problems: Foreign Body In Patient

  MAUDE report 11186244 ↗