Arthrex® AR-8934BCNF-1Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00888867280861), received between Apr 25, 2022 and Jun 5, 2025 — classified as 10 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 16, 2026.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 5, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ANTERIOR TALOFIBULAR LIGAMENT (ATFL) SURGERY THE IMPLANT WENT IN CORRECTLY, WHEN USING THE SUTURES THEY SNAPPED FROM THE ANCHOR WITH LITTLE FORCE. THE SURGEON THEN DRILLED THROUGH THE BROKEN IMPLANT AND USED ANOTHER OF THE SAME. PARTS OF THE BROKEN DEVICE REMAINED INSIDE THE PATIENT. 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 22150590 ↗
• MalfunctionFeb 4, 2025Break; Break

  IT WAS REPORTED THAT DURING A DELTOID REPAIR SURGERY USING THE BIOCOMPOSITES SUTURETAK, THE NEEDLE SNAPPED WHILE PASSING THROUGH SOFT TISSUE AR-8934BCNF-1. THE BROKEN OFF PIECE HAS BEEN RETRIEVED FROM THE PATIENT. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH THE SAME DEVICE USED ANYWAY. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21305449 ↗
• MalfunctionOct 24, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING A MPFL SURGERY THE ANCHOR TORE OF AND DID NOT STAY INSIDE THE KNEE CAP. THE TORN OFF FRAGMENTS WERE 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 20525277 ↗
• MalfunctionSep 3, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ANKLE INSTABILITY SURGERY THE ANCHOR BROKE WHEN BEING INSERTED. 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 20124970 ↗
• MalfunctionMar 14, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A SMALL SURGERY THE ANCHORS AR-8934BCNF-1 (LOT: 15162278) WOULD NOT HOLD AND HAVE BEEN RIPPED OFF. ALL PARTS OF THE DEVICES WERE REMOVED 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 18905575 ↗
• MalfunctionMar 14, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A SMALL SURGERY THE ANCHORS AR-8934BCNF-1 (LOT: 15162278) WOULD NOT HOLD AND HAVE BEEN RIPPED OFF. ALL PARTS OF THE DEVICES WERE REMOVED 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 18905539 ↗
• MalfunctionMar 14, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A SMALL SURGERY THE ANCHORS AR-8934BCNF-1 (LOT: 15162278) WOULD NOT HOLD AND HAVE BEEN RIPPED OFF. ALL PARTS OF THE DEVICES WERE REMOVED 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 18905459 ↗
• MalfunctionOct 17, 2023Defective Device; Defective Device

  IT WAS REPORTED THAT DURING A MEDIALES PATELLOFEMORALES LIGAMENT SURGERY 2 ANCHORS DID NOT HOLD IN THE BALL JOINT. 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 17950295 ↗
• MalfunctionAug 1, 2022Break; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A FOOT ARTHROSCOPY THE ANCHOR TWISTED ON IMPACTION. THE DEVICE BROKE INSIDE THE PATIENT, BUT ALL FRAGMENTS 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: Foreign Body In Patient

  MAUDE report 15137654 ↗
• MalfunctionApr 25, 2022Break

  IT WAS REPORTED THAT DURING AN ANKLE INSTABILITY SURGERY THE ANCHOR BROKE OFF INSIDE THE PATIENT DURING IMPLANTATION IN THE PRE-HOLE. THE BROKEN PIECE WAS RETRIEVED FROM PATIENT AND A NEW ANCHOR HAD TO BE USED TO FINISH THE SURGERY SUCCESSFULLY. 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 14192924 ↗