Arthrex® AR-8990ST-2Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00888867377370), received between Jun 20, 2022 and Dec 24, 2025 — classified as 1 injury, 17 malfunctions.

The most frequently reported specific device problem is “Break” (8 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 24, 2025Break; Break

  IT WAS REPORTED THAT DURING A LATERAL LIGAMENT REPAIR SURGERY WHILE TENSIONING THE ANCHOR AR-8990ST-2 (LOT: 15441448), BOTH SUTURES BROKE WITH TYING THE FIRST KNOT, A SECOND ANCHOR WAS OPENED TO CONCLUDE THE PROCEDURE. 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 23888501 ↗
• MalfunctionNov 4, 2025Material Twisted/Bent; Material Twisted/Bent

  ADDITIONAL INFORMATION WAS RECEIVED ON 10/31/2025: THE ANCHOR WAS REMOVED FROM THE PATIENT, AND ALL FRAGMENTS WERE RETRIEVED. THE CASE WAS COMPLETED USING AR-8934BCST 3.0 SINGLE-LOADED SUTURE TAPE S-TAK ASSY. THERE WAS NO CASE DELAY OR ADDED ANESTHESIA ADMINISTERED TO THE PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 23466928 ↗
• InjuryAug 27, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  ON 8/11/2025, IT WAS REPORTED BY A HEALTH CARE PROVIDER THAT A PATIENT DEVELOPED ECZEMATOUS DERMATITIS FOLLOWING ANKLE SURGERY IN WHICH AN AR-1678-CP INTERNALBRACE LIGAMENT AUGMENTATION REPAIR IMPLANT SYSTEM, AN AR-8990ST-2 FIBERTAK DX, AND AN AR-8990ST FIBERTAK DX WERE IMPLANTED. THE PATIENT HAS A DOCUMENTED CONTACT ALLERGY TO THE PRESERVATIVE 2-BROMO-2-NITROPROPANE-1,3-DIOL (BRONOPOL). NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Contact Dermatitis

  MAUDE report 22902288 ↗
• MalfunctionAug 6, 2025Break; Break

  ON 07/17/2025, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT TWO AR-8990ST-2 FIBERTAK DX SUTURE ANCHORS HAD ISSUES WITH IMPLANTATION. BOTH ANCHORS PULLED OUT DURING INSERTION, AND ONE OF THE ASSOCIATED INSERTER TINES BROKE INTRAOPERATIVELY. THE BROKEN TINE WAS NOT RETAINED IN THE PATIENT, WHICH WAS CONFIRMED VIA X-RAY. TO COMPLETE THE PROCEDURE, THE SURGEON USED DOUBLE-LOADED SUTURETAK ANCHORS, WHICH WERE SUCCESSFULLY IMPLANTED. FOLLOWING THE FAILURE OF THE INITIAL ANCHOR, BOTH THE 1.6 MM AND 1.35 MM DRILLS WERE UTILIZED. THIS OCCURRED DURING A DELTOID LIGAMENT RECONSTRUCTION PROCEDURE ON (B)(6) 2025. ADDITIONAL INFORMATION WAS RECEIVED ON 07/24/2026: AN AR-8934BCST-2 3.0 DOUBLE LOADED SUTURETAPE S-TAK ASSEMBLY AND AR-8934DSC SMALL JOINT SUTURETAK DISPOSABLE INSTRUMENTS KIT WERE USED TO COMPLETE THE PROCEDURE. THERE WAS NO SIGNIFICANT CASE DELAY BEYOND THE TIME REQUIRED TO INSERT THE ANCHOR. BONE QUALITY WAS ASSESSED AS "FINE" AND NOT INDICATIVE OF SOFT BONE. NO ADVERSE EFFECTS WERE REPORTED DURING OR FOLLOWING THE SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22730324 ↗
• MalfunctionAug 6, 2025Break; Break

  ON 07/17/2025, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT TWO AR-8990ST-2 FIBERTAK DX SUTURE ANCHORS HAD ISSUES WITH IMPLANTATION. BOTH ANCHORS PULLED OUT DURING INSERTION, AND ONE OF THE ASSOCIATED INSERTER TINES BROKE INTRAOPERATIVELY. THE BROKEN TINE WAS NOT RETAINED IN THE PATIENT, WHICH WAS CONFIRMED VIA X-RAY. TO COMPLETE THE PROCEDURE, THE SURGEON USED DOUBLE-LOADED SUTURETAK ANCHORS, WHICH WERE SUCCESSFULLY IMPLANTED. FOLLOWING THE FAILURE OF THE INITIAL ANCHOR, BOTH THE 1.6 MM AND 1.35 MM DRILLS WERE UTILIZED. THIS OCCURRED DURING A DELTOID LIGAMENT RECONSTRUCTION PROCEDURE ON (B)(6) 2025. ADDITIONAL INFORMATION WAS RECEIVED ON 07/24/2026: AN AR-8934BCST-2 3.0 DOUBLE LOADED SUTURETAPE S-TAK ASSEMBLY AND AR-8934DSC SMALL JOINT SUTURETAK DISPOSABLE INSTRUMENTS KIT WERE USED TO COMPLETE THE PROCEDURE. THERE WAS NO SIGNIFICANT CASE DELAY BEYOND THE TIME REQUIRED TO INSERT THE ANCHOR. BONE QUALITY WAS ASSESSED AS "FINE" AND NOT INDICATIVE OF SOFT BONE. NO ADVERSE EFFECTS WERE REPORTED DURING OR FOLLOWING THE SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22730323 ↗
• MalfunctionJan 8, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON 12/12/2024, IT WAS REPORTED BY A SALES REPRESENTATIE VIA PHONE THAT (2) AR-8990ST-2 FIBERTAK® DX SUTURE ANCHORS PULLED OUT. THIS OCCURRED DURING A LATERAL ANKLE INSTABILITY REPAIR ON 12/11/2024 THE DEVICES WERE INSERTED AND WHEN GOING TO SET THEM THEY PULLED OUT THE BONE. THE PATIENT HAD GOOD BONE QUALITY AND AN AR-8990DS WAS USED TO PREPARE THE BONE. THE CASE WAS COMPLETED USING (2) AR-8934BCST-2. THIS CAUSED A COUPLE-MINUTE DELAY THAT DID NOT REQUIRE ADDITIONAL ANESTHESIA. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21103881 ↗
• MalfunctionJan 8, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON (B)(6) 2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT (2) AR-8990ST-2 FIBERTAK® DX SUTURE ANCHORS PULLED OUT. THIS OCCURRED DURING A LATERAL ANKLE INSTABILITY REPAIR ON (B)(6)2024 THE DEVICES WERE INSERTED AND WHEN GOING TO SET THEM THEY PULLED OUT THE BONE. THE PATIENT HAD GOOD BONE QUALITY AND AN AR-8990DS WAS USED TO PREPARE THE BONE. THE CASE WAS COMPLETED USING (2) AR-8934BCST-2. THIS CAUSED A COUPLE-MINUTE DELAY THAT DID NOT REQUIRE ADDITIONAL ANESTHESIA. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21103682 ↗
• MalfunctionJan 8, 2025Break; Break

  ON (B)(6) 2024, IT WAS REPORTED BY A DISTRIBUTOR VIA EMAIL THAT AN AR-8990ST-2 FIBERTAK DX ANCHOR FAILED WHEN TYING A KNOT. THIS WAS DISCOVERED DURING AN ANKLE INSTABILITY PROCEDURE ON (B)(6)2024. THE CASE WAS COMPLETED USING A NEW PRODUCT.

  Patient problems: Insufficient Information

  MAUDE report 21102888 ↗
• MalfunctionJun 6, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING AN ANKLE DELTOID LIGAMENT REPAIR THE ANCHOR PULLED OUT INSTANTLY AFTER INSERTING IT. THE SECOND ANCHOR WAS PLACED IN THE SAME HOLE. 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 19478122 ↗
• MalfunctionMay 16, 2024Device Damaged by Another Device; Device Damaged by Another Device

  ON 12/22/2021, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-8990ST-2 DX FIBERTAK WAS INSERTED THROUGH A 1.6MM PREPARED BONE TUNNEL AND AFTER IT PASSED THROUGH THE CORTEX, IT WAS DISCOVERED THAT THE FORKS ON THE INSERTER DEVICE HAD SHREDDED THE SUTURES BUNDLE. THIS WAS DISCOVERED DURING A REVISION OF A FAILED CMC INTERNAL BRACE ON (B)(6) 2021. SURGEON REDIRECTED TUNNELS AND USED A SINGLE-LOADED FIBERTAK DX TO COMPLETE PROCEDURE. ADDITIONAL INFORMATION RECEIVED 12/23/2021. THERE WERE NOT ARTHREX DEVICES EXPLANTED.

  Patient problems: Insufficient Information

  MAUDE report 19330978 ↗
• MalfunctionMay 15, 2024Break; Break

  ON 4/18/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT TWO AR-8990ST-2 FIBERTAK DX BLUE SUTURES SNAPPED WHEN TYING THE KNOT. BOTH WHITE SUTURES OF THE ANCHORS HELD WITHOUT ISSUES. THE BROKEN SUTURES WERE REMOVED FROM INSIDE THE PATIENT. THIS WAS DISCOVERED DURING A REVISION BROSTROM REPAIR PROCEDURE ON (B)(6) 2024. ADDITIONAL INFORMATION WAS RECEIVED ON 5/2/2024. PER THE SALES REPRESENTATIVE, THERE IS NO KNOWN INFORMATION REGARDING THE ORIGINAL SURGERY. THE REASON FOR THE REVISION IS ALSO UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 19325652 ↗
• MalfunctionMay 15, 2024Break; Break

  ON 4/18/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT TWO AR-8990ST-2 FIBERTAK DX BLUE SUTURES SNAPPED WHEN TYING THE KNOT. BOTH WHITE SUTURES OF THE ANCHORS HELD WITHOUT ISSUES. THE BROKEN SUTURES WERE REMOVED FROM INSIDE THE PATIENT. THIS WAS DISCOVERED DURING A REVISION BROSTROM REPAIR PROCEDURE ON (B)(6) 2024. ADDITIONAL INFORMATION WAS RECEIVED ON 5/2/2024. PER THE SALES REPRESENTATIVE, THERE IS NO KNOWN INFORMATION REGARDING THE ORIGINAL SURGERY. THE REASON FOR THE REVISION IS ALSO UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 19323538 ↗
• MalfunctionJan 30, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON 01/09/2024, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA E-MAIL THAT AN AR-8990ST-2 FIBERTAK® DX SUTURE ANCHOR PULLED OUT. THIS OCCURRED ON (B)(6) 2023. NO ADDITIONAL INFORMATION WAS PROVIDED, AND ADDITIONAL INFORMATION HAS BEEN ASKED.

  Patient problems: Insufficient Information

  MAUDE report 18610256 ↗
• MalfunctionJan 30, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON 01/09/2024, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA E-MAIL THAT AN AR-8990ST-2 FIBERTAK® DX SUTURE ANCHOR PULLED OUT. THIS OCCURRED ON (B)(6) 2023. NO ADDITIONAL INFORMATION WAS PROVIDED, AND ADDITIONAL INFORMATION HAS BEEN ASKED.

  Patient problems: Insufficient Information

  MAUDE report 18609135 ↗
• MalfunctionDec 28, 2023Component Missing; Component Missing

  ON 11/29/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT (2) AR-8990ST-2 FIBERTAK DX DID NOT HAVE TWO SUTURES; INSTEAD, THEY ONLY HAD ONE. THIS WAS DISCOVERED UPON OPENING THE PACKAGE DURING A PROCEDURE ON (B)(6) 2023. ADDITIONAL INFORMATION RECEIVED ON 12/8/2023: THIS WAS DISCOVERED DURING A TRICEPS REPAIR PROCEDURE AND WAS COMPLETED WITH THE SECOND AR-8990ST-2 FIBERTAK DX ANCHOR THAT WAS FAULTY. THE CASE WAS DELAYED TEN MINUTES, AND ANESTHESIA WAS ADMINISTERED FOR THE ADDED TIME. THE PATIENT SUFFERED NO NEGATIVE EFFECTS ON OR AFTER THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18408943 ↗
• MalfunctionSep 8, 2023Positioning Failure; Patient Device Interaction Problem; Positioning Failure; Patient Device Interaction Problem

  ON (B)(6) 2023, IT WAS REPORTED BY A PATIENT'S MOTHER VIA PHONE THAT THE PATIENT HAD SUFFERED AN INJURY TO BOTH ANKLES WHILE PLAYING SOCCER. ON (B)(6) 2023, THE PATIENT UNDERWENT SURGERY TO REPAIR THE INJURIES ON BOTH ANKLES USING MULTIPLE AR-8990ST FIBERTAK DX AND AR-8990ST-2 FIBERTAK DX. PER THE MOTHER, THE PATIENT HAD AN ABNORMAL RECOVERY, AND AFTER X-RAYS AND CT SCANS, IT WAS DETERMINED THE FIBERTAK SUTURE ANCHORS ON THE RIGHT ANKLE WERE MISPOSITIONED. THE PATIENT'S MOTHER CALLED TO INQUIRE IF THE IMPLANTS AND ABSORPTION RATE ARE ABSORBABLE. NO FURTHER INFORMATION HAS BEEN REPORTED.

  Patient problems: Foreign Body In Patient; Insufficient Information

  MAUDE report 17713617 ↗
• MalfunctionDec 27, 2022Break; Material Twisted/Bent

  ON 12/05/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-3632 FIBERTAK SUTURE ANCHOR SHAFT BENT, AND AN AR-8990ST-2 FIBERTAK DX SUTURE ANCHOR INSERTER BROKE. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2022.

  Patient problems: Insufficient Information

  MAUDE report 16050936 ↗
• MalfunctionJun 20, 2022Break

  ON (B)(6) 2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-8990ST-2 FIBERTAK DX SUTURE ANCHOR BROKE. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2022.

  Patient problems: Insufficient Information

  MAUDE report 14743798 ↗