Arthrex® AR-8990DSRecalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00888867264984), received between Sep 19, 2022 and Jul 30, 2026 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Break” (7 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 30, 2026Material Twisted/Bent

  Patient problems: Insufficient Information

  MAUDE report 50085247 ↗
• MalfunctionMay 15, 2026Break

  ON 24-APR-2026, AN ARTHREX SUBSIDIARY EMPLOYEE RETURNED AN AR-8990ST FIBERTAK DX SUTURE ANCHOR THAT BROKE DURING INSERTION INTO THE BONE. ADDITIONALLY, AR-8990DS DISPOSABLE KIT FOR DX FIBERTAK RETURNED BECAUSE THE 2 COMPONENTS WERE STUCK TOGETHER AND COULD NOT BE DISASSEMBLED. THE TIP OF THE DEVICE'S GUIDEWIRE WAS BENT. THERE WAS NO SIGNIFICANT CASE DELAY, NO ADDITIONAL ANESTHESIA ADMINISTERED, AND NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25187343 ↗
• MalfunctionNov 4, 2025Break; Break

  ON 10/27/2025, A FACILITY REPRESENTATIVE REPORTED VIA (B)(4) THAT AN AR-8990DS FIBERTAK DX SUTURE ANCHOR DISPOSABLES KIT DRILL BIT TIP BROKE WHEN DRILLING DURING A DELTOID REPAIR. THE CASE WAS COMPLETED BY OPENING ANOTHER DRILL BIT. THE BROKEN PIECE WAS RETRIEVED FROM THE PATIENT WITHOUT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23466754 ↗
• MalfunctionFeb 24, 2025Break; Break

  ON 02/11/2025, A SALES REPRESENTATIVE REPORTED VIA (B)(4) THAT AN AR-8990DS DISPOSABLES KIT BROKE. THIS OCCURRED DURING A CASE WHILE DRILLING. THERE WAS NO ADDITIONAL INFORMATION PROVIDED, AND ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21446595 ↗
• MalfunctionNov 8, 2024Dull, Blunt; Dull, Blunt

  ON 10/24/2024, A SALES REPRESENTATIVE REPORTED VIA (B)(6) THAT AN AR-8990DS DISPOSABLES KIT FOR FIBERTAK HAD DULL DRILL BITS. ANOTHER DISPOSABLE KIT WAS OPENED TO COMPLETE THE CASE, WITH NO ADVERSE EFFECTS ON THE PATIENT. THIS WAS DISCOVERED DURING AN ANKLE DELTOID REPAIR PROCEDURE ON (B)(6) 2024, WITH NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20641511 ↗
• MalfunctionSep 6, 2024Break; Break

  ON 08/15/2024, A DISTRIBUTOR REPORTED VIA (B)(4) THAT AN AR-8990DS DISPOSABLES KIT FOR FIBERTAK DX SUTURE ANCHOR HAD THE 1.6 DRILL BROKEN, WITH NO EFFECT ON THE PATIENT. THIS WAS DISCOVERED DURING A PROCEDURE, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20162534 ↗
• MalfunctionJun 7, 2024Break; Break

  ON 10/1/2021, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT (2) AR-8990ST FIBERTAK SUTURE ANCHORS WOULD NOT DEPLOY AND AN AR-8990DS DRILL GUIDE AND GUIDE WIRE KIT WAS DAMAGED. SURGEON HAS TO USE LARGER ANCHORS TO COMPLETE CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19490331 ↗
• MalfunctionMay 21, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED DURING SURGERY THE K-1 WIRE DRILL WITHIN THE AR-8990DS BENT. THE PROCEDURE WAS COMPLETED WITHOUT ISSUE AFTER RE-DRILLING WITH NEW KIT AND ANCHOR. THE REP REPORTED THE DEVICES DID NOT BREAK INTO DISCRETE PIECES. THE SUTURE ON THE ANCHOR UNLOADED AND WAS PIERCED BY THE FORKED TIP OF THE ANCHOR RENDERING IT UNUSABLE.

  Patient problems: Insufficient Information

  MAUDE report 19357748 ↗
• MalfunctionApr 30, 2024Material Twisted/Bent; Material Twisted/Bent

  ON 09/22/2021 IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA (B)(4) THAT AN AR-8990DS DISPOSABLES KIT WHEN OPENED AND ATTEMPTED TO ATTACH A 1.6 MM DRILL, IT WAS BENT. THIS WAS DISCOVERED DURING A PROCEDURE, THE PROCEDURE WAS COMPLETED USING A NEW PRODUCT, NO PATIENT EFFECT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19215050 ↗
• MalfunctionSep 29, 2023Break; Break

  ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS-06019604 THAT AN AR-8990DS DISPOSABLES KIT, FOR DX FIBERTAK HAD A DRILL BIT BROKE OFF IN THE PATIENT'S PATELLA. ALL FRAGMENTS WERE NOT RETRIEVED FROM THE PATIENT WITH NO FURTHER DELAY. THE CASE WAS COMPLETED WITH NO ISSUES AND NO FURTHER INFORMATION PROVIDED. THIS WAS DISCOVERED DURING A MPFL PROCEDURE ON (B)(6) 2023, WITH NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17842899 ↗
• MalfunctionSep 19, 2022Break

  IT WAS REPORTED ON (B)(6) 2022 BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-8990DS DISPOSABLES KIT WIRE BROKE WHILE DRILLING. THIS WAS DISCOVERED DURING A CASE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15445611 ↗