Arthrex® AR-8998TRecalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00888867301825), received between Mar 23, 2021 and Dec 17, 2025 — classified as 2 injuries, 16 malfunctions.

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

• MalfunctionDec 17, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  ON 11/26/2025, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT TWO AR-8998T NANO SWIVELOCK SUTURE ANCHORS WITH FORK EYELET EXPERIENCED AN ISSUE DURING A SCAPHOLUNATE REPAIR PROCEDURE PERFORMED ON (B)(6) 2025. WHILE INSERTING A 2.5 MM NANO SWIVELOCK ANCHOR, THE TITANIUM PORTION OF THE ANCHOR COLD-WELDED TO THE INSERTER, MAKING REMOVAL FROM THE BONE DIFFICULT. WHEN FORCE WAS APPLIED TO EXTRACT THE ANCHOR, A FRAGMENT OF THE SCAPHOID BONE FRACTURED. THE ISSUE WAS IDENTIFIED DURING USE. ADDITIONAL INFORMATION WAS RECEIVED ON 12/09/2025: DURING THE SCAPHOLUNATE REPAIR PROCEDURE, TWO AR-8998T NANO SWIVELOCK SUTURE ANCHORS WITH FORK EYELET (2.5 X 7 MM) EXPERIENCED COLD-WELDING DURING FINAL ADVANCEMENT. THE BONE TUNNEL WAS NOT TAPPED BEFORE INSERTION, AND THE PATIENT¿S BONE QUALITY WAS ASSESSED AS HARD. BOTH ANCHORS WERE RETRIEVED FROM THE PATIENT, AND ALL FRAGMENTS WERE ACCOUNTED FOR WITH NOTHING REMAINING INSIDE. AS A RESULT OF THE ISSUE, THE SURGEON DRILLED A SECOND HOLE AND USED DIFFERENT ANCHORS, INCLUDING TWO AR-8998T NANO SWIVELOCK SUTURE ANCHORS WITH FORK EYELET (2.5 X 7 MM) AND AN AR-8998DS DISPOSABLE KIT, NANO SWIVELOCK (2.5 X 7 MM). THE REPAIR WAS COMPLETED AS PLANNED WITHOUT THE

  Patient problems: Bone Fracture(s)

  MAUDE report 23827139 ↗
• MalfunctionDec 17, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  ON 11/26/2025, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT TWO AR-8998T NANO SWIVELOCK SUTURE ANCHORS WITH FORK EYELET EXPERIENCED AN ISSUE DURING A SCAPHOLUNATE REPAIR PROCEDURE PERFORMED ON (B)(6) 2025. WHILE INSERTING A 2.5 MM NANO SWIVELOCK ANCHOR, THE TITANIUM PORTION OF THE ANCHOR COLD-WELDED TO THE INSERTER, MAKING REMOVAL FROM THE BONE DIFFICULT. WHEN FORCE WAS APPLIED TO EXTRACT THE ANCHOR, A FRAGMENT OF THE SCAPHOID BONE FRACTURED. THE ISSUE WAS IDENTIFIED DURING USE. ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2025: DURING THE SCAPHOLUNATE REPAIR PROCEDURE, TWO AR-8998T NANO SWIVELOCK SUTURE ANCHORS WITH FORK EYELET (2.5 X 7 MM) EXPERIENCED COLD-WELDING DURING FINAL ADVANCEMENT. THE BONE TUNNEL WAS NOT TAPPED BEFORE INSERTION, AND THE PATIENT¿S BONE QUALITY WAS ASSESSED AS HARD. BOTH ANCHORS WERE RETRIEVED FROM THE PATIENT, AND ALL FRAGMENTS WERE ACCOUNTED FOR WITH NOTHING REMAINING INSIDE. AS A RESULT OF THE ISSUE, THE SURGEON DRILLED A SECOND HOLE AND USED DIFFERENT ANCHORS, INCLUDING TWO AR-8998T NANO SWIVELOCK SUTURE ANCHORS WITH FORK EYELET (2.5 X 7 MM) AND AN AR-8998DS DISPOSABLE KIT, NANO SWIVELOCK (2.5 X 7 MM). THE REPAIR WAS COMPLETED AS PLANNED WITHOUT THE

  Patient problems: Bone Fracture(s)

  MAUDE report 23826994 ↗
• MalfunctionJun 26, 2025Break; Break

  ON 06/04/2025, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT DURING AN ECU PROCEDURE ON 05/27/2025, AN ISSUE OCCURRED INVOLVING AN AR-8998T NANO SWIVELOCK ANCHOR. AS THE PHYSICIAN WAS INSERTING THE ANCHOR INTO THE PRE-DRILLED BONE SOCKET, ONE OF THE FORK TIP TINES BROKE OFF. ALL BROKEN FRAGMENTS WERE SUCCESSFULLY REMOVED, AND NO FURTHER COMPLICATIONS WERE REPORTED. ADDITIONAL INFORMATION RECEIVED ON 6/19/2025: ALL FRAGMENTS WERE SUCCESSFULLY RETRIEVED. TO COMPLETE THE CASE, A NEW AR-8998T NANO SWIVELOCK ANCHOR WAS OPENED AND USED. THE ISSUE CAUSED A MINOR SURGICAL DELAY OF APPROXIMATELY 2 MINUTES. NO ADDITIONAL ANESTHESIA WAS ADMINISTERED.

  Patient problems: Insufficient Information

  MAUDE report 22338318 ↗
• MalfunctionAug 26, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  ON 6/21/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-8998T NANO SWIVELOCK SUTURE ANCHOR WITH FORK EYELET HAD AN ISSUE DURING A HAND SCAPULA RECONSTRUCTION PROCEDURE. AFTER INSERTION, WHEN THE SURGEON WAS TRYING TO ADVANCE THE DEVICE, THE ANCHOR WAS SPINNING AND STUCK TO THE SHAFT. THE SHAFT AND ANCHOR WERE REMOVED FROM THE PATIENT IN ONE PIECE, AND NOTHING BROKE INSIDE THE PATIENT. ANOTHER THREE AR-8998T NANO SWIVELOCK SUTURE ANCHORS WITH FORK EYELET WITH BATCH NUMBER 15165966 WERE USED TO COMPLETE THE PROCEDURE SUCCESSFULLY WITH NO HARM TO THE PATIENT. THERE WAS A SLIGHT CASE DELAY OF UNDER 15 MINUTES AND NO ADDITIONAL ANESTHESIA WAS ADMINISTERED. THE COMPLAINT DEVICE WAS DISCARDED AND NO PICTURES WERE TAKEN. THIS OCCURRED DURING USE WITH NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20063689 ↗
• MalfunctionJun 2, 2024Failure to Advance; Failure to Advance

  ON 12/28/2022, IT WAS REPORTED BY A DISTRIBUTOR VIA SEMS THAT AN AR-8998T NANO SWIVELOCK TITANIUM ANCHOR WAS NOT ADVANCING INTO THE BONE TUNNEL. THIS WAS DISCOVERED DURING USE IN A TFCC REPAIR ON 12/21/2022. THE CASE WAS COMPLETED BY USING A NEW AR-8998T WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19444651 ↗
• InjuryMay 22, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  ON 04/24/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA E-MAIL THAT AN AR-8998T NANO SWIVELOCK® SUTURE ANCHOR WITH FORK EYELET RESULTED IN OSTEOLYSIS AROUND DORSAL NANO SWIVELOCK. THIS OCCURRED DURING A UCL INTERNALBRACE ON (B)(6) 2024. NO ADDITIONAL INFORMATION WAS PROVIDED, AND ADDITIONAL INFORMATION HAS BEEN ASKED. ADDITIONAL INFORMATION RECEIVED ON 4/29/2024: ON 4/24/2024, FOUR MONTHS AFTER THE SURGERY, OSTEOLYSIS WAS NOTICED. REVISION WILL BE NEEDED IN THE FUTURE BUT HAS YET TO OCCUR. ADDITIONAL INFORMATION RECEIVED ON 5/6/2024: THE PROCEDURE OCCURRED ON (B)(6) 2024.

  Patient problems: Osteolysis

  MAUDE report 19369646 ↗
• MalfunctionMay 13, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  ON 4/17/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-8998T NANO SWIVELOCK SUTURE ANCHOR WITH FORK EYELET HAD AN ISSUE DURING A HAND AND WRIST PROCEDURE ON (B)(6) 2024. WHEN THE SURGEON WAS INSERTING THE DEVICE, THE ANCHOR WAS STUCK TO THE DEVICE'S SHAFT AND WOULD NOT COME OFF. IT WAS TRIED AGAIN, BUT THE ANCHOR DID NOT COME OFF. THE DEVICE WAS REMOVED FROM THE PATIENT IN ONE PIECE, WITH THE ANCHOR STUCK TO THE SHAFT, AND NOTHING BROKE OFF INSIDE THE PATIENT. TWO AR-8998T NANO SWIVELOCK SUTURE ANCHORS WITH FORK EYELETS WITH THE SAME LOT NUMBER WERE USED TO COMPLETE THE CASE SUCCESSFULLY WITH NO HARM TO THE PATIENT. THE WAS A 5-MINUTE CASE DELAY, AND IT COULD NOT BE CONFIRMED IF ADDITIONAL ANESTHESIA WAS ADMINISTERED TO THE PATIENT. THE COMPLAINT DEVICE WAS DISCARDED, AND NO PICTURES WERE TAKEN. THIS OCCURRED DURING USE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19297359 ↗
• MalfunctionApr 26, 2024Failure to Advance; Failure to Advance

  ON 12/29/2021, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-8998T NANO SWIVELOCK WOULD NOT DEPLOY EYELET AND ANCHOR INTO THE BONE TUNNEL SURGEON HAD PREVIOUSLY CREATED. SURGEON TRIED MULTIPLE TIMES TO SCREW IN THE IMPLANT BUT EYELET AND ANCHOR WOULD NOT RELEASE FROM DRIVER. THIS WAS DISCOVERED DURING AN UCL INTERNAL BRACE PROCEDURE ON (B)(6) 2021. NOTHING BROKE INSIDE THE PATIENT AND SURGEON WAS ABLE TO COMPLETE CASE SUCCESSFULLY WITHOUT FURTHER ISSUES BY USING A NEW AR-8998T FROM A DIFFERENT LOT NUMBER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19192543 ↗
• MalfunctionApr 18, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON 4/4/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-8998DS NANO SWIVELOCK DISPOSABLE KIT HAD TWO 2.2MM DRILL BITS INSTEAD OF ONE 2.0MM AND ONE 2.2MM. SURGEON USED THE 2.2MM DRILL AND WHEN ANCHOR WAS PLACED, IT PULLED OUT OF IMPLANTATION SITE. THIS WAS DISCOVERED DURING INTERNAL BRACE CONSTRUCT FOR A RADIAL COLLATERAL LIGAMENT REPAIR PROCEDURE ON (B)(6) 2022. ADDITIONAL INFORMATION REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 19132412 ↗
• MalfunctionApr 17, 2024Material Twisted/Bent; Material Twisted/Bent

  ON 21ST MARCH 2024, IT WAS REPORTED BY A SALES REP. VIA EMAIL THAT FOR AN AR-8998T, NANO SWIVELOCK® SUTURE ANCHOR WITH FORK EYELET, THE SCREWDRIVER PART OF THE INSERTER BROKE OFF ON INSERTION OF ANCHOR. THIS WAS DETECTED DURING AN UNSPECIFIED PROCEDURE ON (B)(6) 2024. 25TH MARCH 2024 - THE SALES REP. REPLIED THAT THIS WAS DETECTED DURING USE IN A UCL PROCEDURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AS THE OTHER DRIVER FROM THE OTHER SWIVELOCK WAS USED BUT ALSO BECAME DAMAGED. 4TH APRIL 2024 - THE SALES REP. REPLIED THAT THE OTHER DRIVER WAS ALSO DAMAGED AS IT WAS BENT. HOWEVER, THE PROCEDURE WAS COMPLETED SUCCESSFULLY AS THEY MADE DO WITH THE BENT DRIVER. THE SURGEON WAS NOT HAPPY AND WANTED A SINGLY WRAPPED SPARE STRING DRIVER.

  Patient problems: Insufficient Information

  MAUDE report 19126834 ↗
• MalfunctionApr 16, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  ON 6/1/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-8998T NANO SWIVELOCK ANCHOR WAS NOT ABLE TO DISENGAGE FROM INSERTER. THIS WAS DISCOVERED DURING AN UCL THUMB LIGAMENT REPAIR ON (B)(6) 2022. ADDITIONAL INFORMATION RECEIVED ON 6/2/2022: CASE WAS COMPLETED USING ANOTHER AR-8998T NANO SWIVELOCK. NOTHING BROKE INSIDE THE PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 19117448 ↗
• MalfunctionApr 12, 2024Break; Break

  ON 21ST MARCH 2024, IT WAS REPORTED BY A SALES REP. VIA EMAIL THAT FOR AN AR-8998T, NANO SWIVELOCK® SUTURE ANCHOR WITH FORK EYELET, THE SCREWDRIVER PART OF THE INSERTER BROKE OFF ON INSERTION OF ANCHOR. THIS WAS DETECTED DURING AN UNSPECIFIED PROCEDURE ON (B)(6) 2024. 25TH MARCH 2024 - THE SALES REP. REPLIED THAT THIS WAS DETECTED DURING USE IN A UCL PROCEDURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AS THE OTHER DRIVER FROM THE OTHER SWIVELOCK WAS USED BUT ALSO BECAME DAMAGED. 4TH APRIL 2024 - THE SALES REP. REPLIED THAT THE OTHER DRIVER WAS ALSO DAMAGED AS IT WAS BENT. HOWEVER, THE PROCEDURE WAS COMPLETED SUCCESSFULLY AS THEY MADE DO WITH THE BENT DRIVER. THE SURGEON WAS NOT HAPPY AND WANTED A SINGLY WRAPPED SPARE STRING DRIVER.

  Patient problems: Insufficient Information

  MAUDE report 19098383 ↗
• MalfunctionMar 29, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  ON 03/04/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT DURING AN UCL INTERNAL BRACE PROCEDURE ON (B)(6) 2022, AN AR-8998T NANO SWIVELOCK® SUTURE ANCHOR WITH FORK EYELET HAD AN ISSUE. THE ANCHOR WOULD NOT COME OFF THE DRIVER, IT WAS STUCK, IT COULD NOT BE IMPLANTED AND HAD TO BE REMOVED FROM THE PATIENT. NOTHING BROKE INSIDE THE PATIENT, THE FULL ANCHOR WAS REMOVED, BEING STUCK TO THE DEVICE. THE CASE WAS COMPLETED BY USING ANOTHER AR-8998T NANO SWIVELOCK® SUTURE ANCHOR WITH A DIFFERENT LOT NUMBER, AND THE CASE WAS COMPLETED SUCCESSFULLY WITH NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19004244 ↗
• MalfunctionJan 30, 2024Break; Break

  ON 01/09/2024, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA E-MAIL THAT AN AR-8998T NANO SWIVELOCK® SUTURE ANCHOR BROKE. THIS OCCURRED ON (B)(6) 2023. NO ADDITIONAL INFORMATION WAS PROVIDED, AND ADDITIONAL INFORMATION HAS BEEN ASKED.

  Patient problems: Insufficient Information

  MAUDE report 18610237 ↗
• MalfunctionJan 22, 2024Fitting Problem; Fitting Problem

  ON 01/03/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-8998T SCREW DID NOT FIT ONTO THE INSERTER, THE ANCHOR WAS FAULTY. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18552527 ↗
• MalfunctionMay 9, 2022Break

  ON 04/21/2022, IT WAS REPORTED BY A PATIENT VIA PHONE THAT ON (B)(6) 2021 SHE UNDERWENT A UCL REPAIR IN THE THUMB WHERE AN AR-8987P, AR-8978P, AND A AR-8998T WERE BEING IMPLANTED. ONCE THE PROCEDURE WAS COMPLETED, THE SURGEON WAS REVIEWING HER X-RAYS AND MRI WITH THE PATIENT REVIEWING PLACEMENT OF THE IMPLANTS, HOWEVER INSTEAD OF 3 THERE WERE ONLY 2. THE PATIENT WAS TOLD THAT DURING THE PROCEDURE ONE OF THE IMPLANTS HAD BROKE. THERE WAS NO DETAILS PROVIDED AS TO HOW, OR WHERE. ADDITIONAL INFORMATION BEING REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 14337590 ↗
• MalfunctionMar 21, 2022Break

  ON 2/28/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-8998T NANO SWIVELOCK BROKE PREMATURELY. THIS WAS DISCOVERED DURING A THUMB UCL REPAIR ON (B)(6) 202022. CASE WAS COMPLETED USING 8 2.5MM MINI PUSHLOCK ANCHORS. ADDITIONAL INFORMATION REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 13839437 ↗
• InjuryMar 23, 2021Physical Resistance/Sticking

  IT WAS REPORTED DURING A VOLAR PLATE REPAIR FOR A FINGER DISLOCATION, AS THE SURGEON WAS PUTTING IN THE AR-8998T NANO SWIVELOCK ANCHOR, THE ANCHOR GOT STUCK ON THE DRIVER HALFWAY DOWN AND THE ANCHOR WOULD NOT DEPLOY AND BECAME COMPLETELY STUCK ON DRIVER. DUE TO THE ISSUE THE SURGEON HAD TO CHANGE THEIR ORIGINAL SURGICAL PLAN AND COMPLETE THE CASE BY DOING BONE TUNNELS WITH FIBERWIRE.

  Patient problems: Insufficient Information

  MAUDE report 11553047 ↗