Arthrex® AR-8990ST-1Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00888867301078), received between Dec 29, 2023 and Feb 6, 2026 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 6, 2026Break

  ON (B)(6) 2026, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT FOR AN AR-8990ST-1, FIBERTAK® DX SUTURE ANCHOR WITH 1.3 MM SUTURETAPE, THE SURGEON INSERTED THE ANCHOR AND WENT TO DO A SOFT SET, AND THE ANCHOR HAD STRIPPED OFF FROM THE SUTURES. IT LOOKED LIKE A CLEAN CUT. THIS WAS DETECTED DURING A LATERAL LIGAMENT REPAIR PROCEDURE ON (B)(6) 2026. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AS A NEW ANCHOR WAS USED.

  Patient problems: Insufficient Information

  MAUDE report 24281758 ↗
• MalfunctionJan 26, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING THE ARTHROSCOPY, THE ANCHOR WAS PULLED OUT AFTER IT HAD BEEN INSERTED INTO THE BONE. 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 24183096 ↗
• MalfunctionOct 16, 2025Break; Break

  IT WAS REPORTED DURING THE ANTERIOR TALOFIBULAR LIGAMENT REPAIR THAT THE BLUE HANDLE FELL OFF THE DEVICE WHEN IT WAS PULLED. THE BROKEN-OFF PART DID NOT FALL INTO THE PATIENT. PER COMPLAINT REPORTER 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23309736 ↗
• MalfunctionJun 4, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ON 15 MAY 2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT 2 X AR-8990ST-1, DX FIBERTAK SUTURE ANCHOR ST & NDLS WERE REPORTED TO HAVE FAILED DURING USE. THIS OCCURRED ON (B)(6) URING A LATERAL LIGAMENT RECONSTRUCTION. IT WAS REPORTED THAT TWO DX FIBERTAK ANCHORS (AR-8990ST) WERE USED IN A LATERAL LIGAMENT REPAIR. UPON DEPLOYMENT, THE ANCHOR TOP PULLED STRAIGHT OFF THE METAL ROD THAT INSERTS THE ANCHOR BODY. THIS LEFT THE METAL ROD STUCK INSIDE THE BONE, MEANING THE SURGEON WAS FORCED TO REMOVE USING A WIRE DRIVER. THIS HAPPENED TO BOTH THE ANCHORS. THE CASE WAS COMPLETED SUCCESSFULLY WITH THE SURGEON REMOVING THE METAL INSERTER ROD WITH A WIRE DRIVER INSTEAD. THERE WAS CASE INVOLVEMENT.

  Patient problems: Insufficient Information

  MAUDE report 22143953 ↗
• MalfunctionJun 4, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ON 15 MAY 2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT 2 X AR-8990ST-1, DX FIBERTAK SUTURE ANCHOR ST & NDLS WERE REPORTED TO HAVE FAILED DURING USE. THIS OCCURRED ON (B)(6) 2025 DURING A LATERAL LIGAMENT RECONSTRUCTION. IT WAS REPORTED THAT TWO DX FIBERTAK ANCHORS (AR-8990ST) WERE USED IN A LATERAL LIGAMENT REPAIR. UPON DEPLOYMENT, THE ANCHOR TOP PULLED STRAIGHT OFF THE METAL ROD THAT INSERTS THE ANCHOR BODY. THIS LEFT THE METAL ROD STUCK INSIDE THE BONE, MEANING THE SURGEON WAS FORCED TO REMOVE USING A WIRE DRIVER. THIS HAPPENED TO BOTH THE ANCHORS. THE CASE WAS COMPLETED SUCCESSFULLY WITH THE SURGEON REMOVING THE METAL INSERTER ROD WITH A WIRE DRIVER INSTEAD. THERE WAS CASE INVOLVEMENT.

  Patient problems: Insufficient Information

  MAUDE report 22143818 ↗
• MalfunctionMay 28, 2025Material Twisted/Bent; Material Twisted/Bent

  ON 11 MAY 2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT 2 X AR-8990ST-1 DX FIBERTAK SUTURE ANCHORS, ST & NDLS WERE REPORTED TO HAVE BENT DURING INSERTION. THIS OCCURRED ON (B)(6) 2025 DURING A LATERAL LIGAMENT REPAIR. THE CASE WAS COMPLETED SUCCESSFULLY USING AR-8990ST-1 AND SWITCHING TO A 1.6 DRILL. THERE WAS CASE INVOLVEMENT.

  Patient problems: Insufficient Information

  MAUDE report 22096706 ↗
• MalfunctionMay 28, 2025Material Twisted/Bent; Material Twisted/Bent

  ON 11 MAY 2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT 2 X AR-8990ST-1 DX FIBERTAK SUTURE ANCHORS, ST & NDLS WERE REPORTED TO HAVE BENT DURING INSERTION. THIS OCCURRED ON (B)(6) 2025 DURING A LATERAL LIGAMENT REPAIR. THE CASE WAS COMPLETED SUCCESSFULLY USING AR-8990ST-1 AND SWITCHING TO A 1.6 DRILL. THERE WAS CASE INVOLVEMENT.

  Patient problems: Insufficient Information

  MAUDE report 22096663 ↗
• MalfunctionAug 20, 2024Device Dislodged or Dislocated; Loosening of Implant Not Related to Bone-Ingrowth; Device Dislodged or Dislocated; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT DURING A BROSTROM SURGERY THE ANCHORS CAME LOOSE OUT OF THE BONE. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH THE SAME DEVICES. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20006756 ↗
• MalfunctionMay 22, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ON 05/26/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT THE SUTURETAPE COMPONENT OF AN AR-990ST-1 FIBERTAK BECAME DISCONNECTED FROM THE NEEDLES. THIS WAS DISCOVERED AFTER THE ANCHOR WAS INSERTED WHEN RELEASING THE NEEDLES FROM THE TOP OF THE INSERTER. THE FREE NEEDLES DID NOT COME INTO CONTACT WITH THE PATIENT AND ADEQUATE FIXATION WAS ACHIEVED USING A DIFFERENT NEEDLE WITH NO CHANGE TO SURGICAL TECHNIQUE.

  Patient problems: Insufficient Information

  MAUDE report 19373813 ↗
• MalfunctionMar 8, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ON 26TH FEBRUARY 2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-8990ST-1,FIBERTAK® DX SUTURE ANCHOR WITH 1.3 MM SUTURETAPE WAS IMPLANTED, BUT ONE OF THE NEEDLES WAS NOT ATTACHED TO THE TAPE AND THERE WAS ONLY 1 NEEDLE ATTACHED TO THE END OF THE TAPE. THE OTHER NEEDLE WAS RETAINED IN THE NEEDLE PROTECTOR. THIS WAS DETECTED DURING USE IN AN UNSPECIFIED PROCEDURE ON (B)(6) 2024. 27TH FEBRUARY 2024 - THE SALES REP. REPLIED THAT IT WAS A SCARF / AKIN PROCEDURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AS A MAYO NEEDLE WAS ATTACHED TO THE SUTURE TAPE THAT WAS MISSING THE NEEDLE. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18869710 ↗
• MalfunctionFeb 2, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ON 27TH SEPTEMBER 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-8990ST-1, DX FIBERTAK SUTURE ANCHOR, ST & NDLS HAS ONE OF ITS NEEDLES DETACHED FROM THE SUTURE TAPE. WHEN THE FIBERTAK WAS INSERTED, THE SURGEON REMOVED THE SUTURES FROM THE GUIDE AND TOOK THE SHEATH OFF THE NEEDLES. IT WAS THEN NOTICED THAT ONE OF THE NEEDLES WAS DETACHED FROM THE SUTURE TAPE. THIS WAS DETECTED OUT-OF-BOX, ON 27TH SEPTEMBER 2023 WITH NO CASE INVOLVEMENT.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18633997 ↗
• MalfunctionDec 29, 2023Packaging Problem; Packaging Problem

  ON 6TH DECEMBER 2023, IT WAS REPORTED BY A SALES REP VIA EMAIL THAT AN AR-8990STFIBERTAK® DX SUTURE ANCHOR WITH 1.3 MM SUTURETAPE, VE5 WAS OPENED FOR A PROCEDURE AND IT WAS PACKAGED AND LABELLED AS FIBERTAK DX SUTURE ANCHOR WITH 1.3 MM SUTURETAPE, AR-8990ST LOT 1514890. HOWEVER, THE IMPLANT FOUND IN THE PACKAGING WAS FIBERTAK DX SUTURE ANCHOR, DOUBLE-LOADED AR-8990ST-2. THIS WAS DETECTED ON (B)(6) 2023 DURING AN AITFL STABILIZATION PROCEDURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY USING THE DEVICE AND THE EXTRA SUTURE TAPE WAS DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18419947 ↗