Arthrex® AR-8990Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 00888867265004), received between Dec 21, 2017 and Sep 24, 2026 — classified as 9 injuries, 13 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (6 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• InjurySep 24, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Pain

  MAUDE report 50887098 ↗
• InjurySep 24, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Pain

  MAUDE report 50886600 ↗
• InjurySep 24, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Pain

  MAUDE report 50886484 ↗
• InjurySep 24, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Pain

  MAUDE report 50886299 ↗
• InjurySep 24, 2026Adverse Event Without Identified Device or Use Problem

  On (b)(6) 2026, an Arthrex employee reported on behalf of an individual who underwent bilateral peroneus brevis and peroneus longus repair procedure and had an Arthrex FiberTak anchor implanted. The employee stated that, during a meeting with the patient on (b)(6) 2026, the patient reported that the implant did not help and that they were experiencing daily pain. No further information was provided.Additional information was received on 21-Sep-2026:The reporter stated that the individual indicated the reported pain may be unrelated to the treatment and could be associated with rheumatoid arthritis.Review of the operative report dated (b)(6) 2023 indicates that the following Arthrex implants were implanted on the right side: two KT InternalBrace BioComposite 4.75 mm implants and two AR-8990 FiberTak DX Suture Anchors. No infection was documented at the time of surgery. No intraoperative complications were reported. The patient was transferred to PACU in stable condition and subsequently discharged home.Review of the operative report dated (b)(6) 2023 indicates that the following Arthrex implants were implanted on the left side: one AR-1789J-CP InternalBrace Implant System and three

  Patient problems: Pain

  MAUDE report 50886176 ↗
• InjurySep 24, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Pain

  MAUDE report 50885890 ↗
• InjurySep 24, 2026Adverse Event Without Identified Device or Use Problem

  On (b)(6) 2026, an Arthrex employee reported on behalf of an individual who underwent bilateral peroneus brevis and peroneus longus repair procedure and had an Arthrex FiberTak anchor implanted. The employee stated that, during a meeting with the patient on (b)(6) 2026, the patient reported that the implant did not help and that they were experiencing daily pain. No further information was provided.Additional information was received on 21-Sep-2026:The reporter stated that the individual indicated the reported pain may be unrelated to the treatment and could be associated with rheumatoid arthritis.Review of the operative report dated (b)(6) 2023 indicates that the following Arthrex implants were implanted on the right side: two KT InternalBrace BioComposite 4.75 mm implants and two AR-8990 FiberTak DX Suture Anchors. No infection was documented at the time of surgery. No intraoperative complications were reported. The patient was transferred to PACU in stable condition and subsequently discharged home.Review of the operative report dated (b)(6) 2023 indicates that the following Arthrex implants were implanted on the left side: one AR-1789J-CP InternalBrace Implant System and three

  Patient problems: Pain

  MAUDE report 50885119 ↗
• MalfunctionJul 30, 2026Device Dislodged or Dislocated

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50084677 ↗
• MalfunctionJul 28, 2026Break

  Patient problems: Foreign Body In Patient

  MAUDE report 50056210 ↗
• MalfunctionDec 16, 2025Material Twisted/Bent; Material Twisted/Bent

  ON 11/21/2025, AN ARTHREX SUBSIDIARY EMPLOYEE REPORTED VIA EMAIL THAT AN AR-8990DS DISPOSABLES KIT FOR FIBERTAK DX SUTURE ANCHOR AND AN AR-8990 FIBERTAK DX SUTURE ANCHOR WERE INVOLVED IN AN ISSUE DURING SURGERY. THE SURGEON REQUESTED THE FIBERTAK ANCHOR AND PROCEEDED WITH THE STANDARD TECHNIQUE, INSERTING THE DRILL BIT AND THEN HAMMERING THE ANCHOR. DURING INSERTION, THE ANCHOR TIP BENT. AN ATTEMPT WAS MADE TO CORRECT THE TIP FOR CONTINUED USE, BUT THE SAME ISSUE OCCURRED; THE TIP BENT AGAIN. THE PATIENT¿S BONE QUALITY WAS ASSESSED AS GOOD, AND NO ADDITIONAL ANESTHESIA WAS ADMINISTERED. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2025, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION WAS RECEIVED ON 12/02/2025: THIS OCCURRED DURING A RECONSTRUCTION OF THE TENDON OF THE SECOND TOE PROCEDURE. THE ANCHOR BENT TWICE DURING INITIAL INSERTION. THE TIP WAS CORRECTED USING A KELLY INSTRUMENT. THE BENT ANCHOR WAS REMOVED AND NOT IMPLANTED. THE PROCEDURE WAS COMPLETED WITHOUT SURGICAL DELAY. THE DRILL BIT FROM THE KIT WAS USED FOR PREPARING THE BONE. NO PHOTOS WERE TAKEN, AND NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23815205 ↗
• MalfunctionDec 10, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON NOVEMBER 24, 2025, AN ARTHREX SUBSIDIARY EMPLOYEE REPORTED VIA (B)(4) THAT THE AR-8990 FIBERTAK DX WOULD NOT PERFORM AND PULLED OUT. THIS WAS DISCOVERED DURING USE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23771026 ↗
• MalfunctionMar 12, 2025Break; Break

  ON 02/14/2025, AN ARTHREX SUBSIDIARY EMPLOYEE REPORTED VIA EMAIL THAT AN AR-8990 FIBERTAK DX SUTURE ANCHOR HAD THE TIP OF THE INSERTER BREAK AND LEAVING A 1-2 MM FRAGMENT INSIDE THE PATIENT. THE FRAGMENT WAS NOT RETRIEVED FROM THE PATIENT. THE CASE WAS COMPLETED SUCCESSFULLY. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2025. ADDITIONAL INFORMATION WAS RECEIVED ON 02/25/2025: NO ADDITIONAL PRODUCT WAS USED TO COMPLETE THE CASE, NO CASE DELAY, AND NO ADDED ANESTHESIA WAS ADMINISTERED TO THE PATIENT. NO REVISION SURGERY WAS NEEDED TO REMOVE THE BROKEN FRAGMENT FROM THE PATIENT, AND NO ADDITIONAL TREATMENT FOR THE PATIENT WAS REQUIRED. THE PATIENT DID NOT EXPERIENCE A REDUCED QUALITY OF LIFE DUE TO THE DEVIATION, AND NO HOSPITALIZATION WAS NEEDED. THIS OCCURRED DURING A SHOULDER PROCEDURE ON (B)(6) 2025.

  Patient problems: Foreign Body In Patient

  MAUDE report 21585963 ↗
• MalfunctionJun 25, 2024Break; Break

  ON 05/30/2024 AN FDA MEDWATCH NOTIFICATION WAS RECEIVED VIA EMAIL. A FACILITY REPRESENTATIVE REPORTED THAT AN AR-8990 FIBERTAK DX TIP BROKE OFF DURING INSERTION. THIS WAS DISCOVERED DURING A DISTAL EXTREMITY LIGAMENT REPAIR PROCEDURE ON (B)(6) 2023.

  Patient problems: Insufficient Information

  MAUDE report 19604486 ↗
• MalfunctionMay 25, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON 6/24/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-8990 FIBERTAK DX SUTURE ANCHOR, AFTER USING THE AR-8990DS DRILL KIT AND DRILLING THE BONE SOCKET, THE ANCHOR WOULD NOT DEPLOY NOR ENGAGE IN THE BONE. SURGEON OPENED ANOTHER ANCHOR AND WAS ABLE TO COMPLETE THE CASE WITHOUT FURTHER ISSUES. THIS WAS DISCOVERED DURING AN EXTENSOR CARPI RADIALIS BREVIS REPAIR ON 6/24/2022.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19398296 ↗
• MalfunctionMay 8, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING AN ANKLE INTERNAL BRACE PROCEDURE, THE AR-2325PSLC AND THE AR-8990, PULLED OUT DUE TO THE BONE QUALITY AND LOCATION. NO ADDITIONAL INFORMATION PROVIDED. ADDITIONAL INFORMATION REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 19267076 ↗
• MalfunctionMay 7, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON 15 APRIL 2024 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-8990 DX FIBERTAK SUTURE ANCHOR, #1 FW & NDLS FAILED TO SET AND CONTINUOUSLY PULLED OUT. THERE WAS CASE/PATIENT INVOLVEMENT.

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

  MAUDE report 19262453 ↗
• MalfunctionMay 6, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT AFTER PULLING THE INSERTER OF THE AR-8990 FIBERTAK SUTURE ANCHOR AND COMPLETING THE DETENTION, THE SURGEON REMOVED IT FROM THE GUIDE AND CHECKED THE PLACEMENT OF THE ANCHOR BY PULLING IT AND THE ANCHOR CAME OFF. SURGEON INSTALLED A NEW PRODUCT IN A DIFFERENT PLACE AND SURGERY WAS COMPLETED SUCCESSFULLY WITH NO ADVERSE EFFECT ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19250261 ↗
• MalfunctionMar 1, 2024Material Deformation; Material Deformation

  ON 02/14/2024, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA E-MAIL THAT AN AR-8990 FIBERTAK¿ DX SUTURE ANCHORS INSERTER SHAFT WAS CRUSHED, RESULTING IN POOR INSERTION. THIS OCCURRED DURING A PROCEDURE UPON INSERTING IT INTO THE FIBULA, THE INSERTER SHAFT WAS CRUSHED, RESULTING IN POOR INSERTION. THE BONE WAS PREPPED USING A F1.6MM DRILL INSIDE THE AR-8990DS. THE SURGEON CREATED AN ADDITIONAL BONE HOLE WITH A F1.8MM K WIRE AND INSERTED IT AGAIN. HE WAS ABLE TO INSERT IT WITH LITTLE RESISTANCE, AND TO RECOVER WITHOUT ANY FIXATION PROBLEMS. ADDITIONAL INFORMATION PROVIDED 2/20/24: THE PROCEDURE PERFORMED WAS A ATFL REPAIR. NOTHING BROKE OFF INSIDE OF THE PATIENT. NO IMAGES OR VIDEOS ARE AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 18817565 ↗
• MalfunctionNov 15, 2023Material Fragmentation; Material Fragmentation

  ON (B)(6) 2023 IT WAS REPORTED, BY A PATIENT VIA PHONE, THAT AN MRI PERFORMED IN SEPTEMBER SHOWED FRAGMENTS OF A FOREIGN OBJECT. THE PATIENT HAD UNDERGONE SURGERY BACK IN AUGUST OF 2022 IN WHICH A FIBERTAK WAS USED. THE PATIENT IS CONTACTING ARTHREX TO OBTAIN MATERIAL COMPOSITION FOR THE FIBERTAK. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 18138599 ↗
• MalfunctionSep 26, 2022Break

  ON 09/07/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT A AR-8990 FIBERTAK ANCHOR SHEATH BROKE OFF IN THE FIBULA THIS OCCURRED DURING A CASE AND BROKE INSIDE THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 15484151 ↗
• InjurySep 19, 2022Break

  ON (B)(6) 2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-8990 FIBERTAK¿ DX SUTURE ANCHOR HAD AN ISSUE. DURING A LATERAL ANKLE RECONSTRUCTION PROCEDURE, A BROSTROM REPAIR ON (B)(6) 2022, WHEN THE SURGEON WAS TRYING TO USE THE INSERTER TO IMPLANT THE ANCHOR, THE METAL TIP WITH THE SUTURE ANCHOR BROKE OFF INSIDE THE PATIENT, THE METAL TIP WAS LEFT INSIDE THE PATIENT, AND IT WAS NOT CONFIRMED IF THE ANCHOR ITSELF WAS LEFT AS WELL INSIDE THE PATIENT. THE SURGEON DID NOT RETRIEVE THE BROKEN FRAGMENT, HE WAS ABLE TO USE ANOTHER AR-8990 FIBERTAK¿ DX SUTURE ANCHOR, A DIFFERENT LOT NUMBER, TO COMPLETE THE SURGERY SUCCESSFULLY WITH NO FURTHER IMPACT TO THE PATIENT. ON (B)(6) 2022, THE SAME SURGEON PERFORMED A REVISION SURGERY ON THE PATIENT TO REMOVE THE BROKEN METAL TIP/PIECE FROM THE PATIENT, THE SURGERY SITE ITSELF FROM THE PREVIOUS SURGERY WAS LEFT ALONE. THIS REVISION SURGERY WAS COMPLETED SUCCESSFULLY, THE METAL TIP WAS SUCCESSFULLY REMOVED AND THE PATIENT IS FINE TO DATE.

  Patient problems: Foreign Body In Patient

  MAUDE report 15445707 ↗
• InjuryDec 21, 2017Bent; Difficult to Remove

  IT WAS REPORTED THAT DURING A LATERAL ANKLE STABILIZATION PROCEDURE, AS THE SURGEON WAS INSERTING THE DX FIBERTAK SUTURE ANCHOR (LOT: S704385, LINE 216130), THE TIP OF THE SUTURE ANCHOR BENT. A SECOND DX FIBERTAK SUTURE ANCHOR OF THE SAME LOT (LOT: S704385, LINE 216131) WAS OPENED AND USED AND UPON INSERTION, ONE OF THE 2 PRONGS BROKE OFF OF THE DEVICE. THE PRONG WAS NOT ABLE TO BE RETRIEVED FROM THE PATIENT. AN X-RAY WAS TAKEN POST-OP AND THE PRONG IS VISIBLE. THE 1.6 GUIDE WIRE AND CANNULA FROM THE DISPOSABLE KIT WERE USED TO PREP THE BONE WITH NO INCIDENT. THE CASE WAS COMPLETED WITH A AR-1322BCNF INSTEAD. PATIENT IS A FEMALE, (B)(6). FOLLOW-UP INVESTIGATION: THE FIRST FIBERTAK SUTURE THAT BENT WAS REMOVED FROM THE PATIENT. BOTH ANCHORS ARE BEING RETURNED FOR EVALUATION.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 7137335 ↗