Arthrex® AR-8991-1Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00888867377301), received between Sep 29, 2023 and Mar 10, 2026 — classified as 7 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 10, 2026Break

  IT WAS REPORTED THAT DURING A SURGERY THE ANCHOR BROKE. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. NO FURTHER INFORMATION RECEIVED. UPDATE 04-MAR-2026: FURTHER INFORMATION WAS PROVIDED THAT THE REPORTED ISSUE OCCURRED DURING AN ANKLE STABILIZATION OF THE LEFT FIBULA. IT WAS FURTHER CLARIFIED THAT, CONTRARY TO THE INITIAL REPORT, THE ANCHOR HAD NOT FAILED. INSTEAD, IT WAS CONFIRMED THAT THE TIP OF THE DRIVER HAD BROKEN OFF, NOT 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 24556960 ↗
• MalfunctionNov 25, 2025Positioning Failure; Positioning Failure

  IT WAS REPORTED DURING A RECONSTRUCTION OF THE MEDIAL COLLATERAL LIGAMENT OF THE ANKLE THAT THE ANCHOR DID NOT UNFOLD AFTER BEING INSERTED INTO THE BONE TUNNEL AND WAS PULLED OUT. 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 DO A SECOND SURGERY BUT THE SURGEON USED A DIFFERENT SURGICAL TECHNIQUE, IN WHICH HE USED A TRANSOSSEOUS TUNNEL TO INSERT VICRYL SUTURES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23647045 ↗
• MalfunctionNov 20, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON 30TH OCTOBER 2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-8991-1 DX FIBERTAK SUTURE ANCHOR, #2 MTS W/ NDL WAS REPORTED TO HAVE BEEN PULLED OUT WITH MINIMAL FORCE ON TENSIONING, DESPITE THE IMPLANTS BEING INSERTED CORRECTLY. THIS WAS DETECTED DURING ARTHROBROSTRUM PROCEDURE ON (B)(6) 2024. PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO PATIENT HARM BY USING ADDITIONAL IMPLANTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20735279 ↗
• MalfunctionSep 25, 2024Break; Use of Device Problem; Break; Use of Device Problem

  ON 18 SEPTEMBER 2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-8991-1 DX FIBERTAK SUTURE ANCHOR, #2 MTS W/ NDL WAS REPORTED TO HAVE FAILED DURING USE. THIS OCCURRED ON 03 SEPTEMBER 2024 IN CASTLECRAG PRIVATE HOSPITAL DURING AN ARTHROBROSTRUM. THE CASE WAS COMPLETED SUCCESSFULLY USING ADDITIONAL ANCHORS. THERE WAS CASE INVOLVEMENT.

  Patient problems: Insufficient Information

  MAUDE report 20300256 ↗
• MalfunctionFeb 16, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ANKLE INSTABILITY ARTHROSCOPY, AFTER ANCHOR INSERTION AND AFTER PASSING THE BLUE SUTURE THROUGH THE TISSUE THE SURGEON PASSED THE WORKING BLUE SUTURE THROUGH THE BLACK AND WHITE FIBERLINK LOOP AND DOUBLE IT OVER AT THE SECOND PURPLE MARKING. AFTER PULLING THE BLACK AND WHITE SUTURE OUT OF THE PATIENT THE END OF THE BLUE FIBERLINK SUTURE BROKE AND SURGEON COULDN¿T TENSION THE SUTURE OR EVEN TAKE THE ANCHOR OUT OF 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 18722249 ↗
• MalfunctionJan 4, 2024Break; Break

  IT WAS REPORTED THAT DURING AN INSTABILITY REPAIR SURGERY AFTER THE ANCHOR WAS INTRODUCED, A SMALL PART OF METAL FROM THE ANCHOR DRIVER BROKE OFF INSIDE THE PATIENT. THE BROKEN PIECE REMAINS INSIDE THE PATIENT. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH THE SAME DEVICE WAS USED ANYWAY. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: Foreign Body In Patient

  MAUDE report 18443992 ↗
• MalfunctionSep 29, 2023Break; Break

  IT WAS REPORTED THAT DURING A BROSTROM SURGERY THE TAPES SNAPPED OFF. 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: Failure of Implant

  MAUDE report 17845160 ↗