Arthrex® AR-8991CPRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00888867424715), received between Apr 22, 2025 and May 20, 2026 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (2 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 20, 2026

  AN ANCHOR FROM THE DX KNOTLESS FIBER TAK INSTABILITY IMPLANT KIT WAS BROKE OFF/RETAINED DURING THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25228934 ↗
• InjuryDec 30, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  ON (B)(6) 2025, IT WAS REPORTED BY A PATIENT THAT JUMPSTART WAS USED DURING A RECENT ACL SURGERY. FOLLOWING THE PROCEDURE, THE PATIENT EXPERIENCED AN EXTREME TOPICAL ALLERGIC REACTION. NO FURTHER INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION WAS RECEIVED ON 15-DEC-2025: THE PATIENT REPORTED THAT JUMPSTART FROM AN AR-8991CP DX KNOTLESS FIBERTAK IMPLANT KIT WAS APPLIED ON (B)(6) 2025, THE SAME DAY AS THE PROCEDURE. THE PATIENT LATER EXPERIENCED DELAYED ITCHING, INFLAMMATION, AND BLISTERING OF THE SKIN. HOWEVER, THE SPECIFIC ALLERGEN INVOLVED HAS NOT BEEN CONFIRMED. THE REACTION WAS TREATED WITH A STEROID CREAM.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 23921140 ↗
• MalfunctionDec 9, 2025Positioning Failure; Material Split, Cut or Torn; Positioning Failure; Material Split, Cut or Torn

  ON 11/20/2025, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT AN AR-8991CP DX KNOTLESS FIBERTAK IMPLANT KIT EXPERIENCED AN ISSUE DURING USE. THE PASSING SUTURE BECAME DE-THREADED AND ULTIMATELY TORE WHILE ATTEMPTING TO PASS THE REPAIR STITCH. THIS RESULTED IN A SITUATION WHERE THE ANCHOR WAS ALREADY SEATED IN THE BONE, AND THE REPAIR STITCH HAD BEEN PASSED THROUGH THE LIGAMENT TO THE SURGEON¿S SATISFACTION. ADDITIONALLY, THE SECOND ANCHOR IN THE KIT FAILED TO SEAT PROPERLY. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2025, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION WAS RECEIVED ON 12/01/2025: DURING AN ATFL INTERNAL BRACE PRIMARY REPAIR, TWO SUTURE ANCHORS FROM THE KIT FAILED. THE FIRST ANCHOR WAS REMOVED FROM THE PATIENT BECAUSE IT WAS NOT SEATED PROPERLY, POSSIBLY DUE TO HUMAN ERROR OR IMPLANTATION STRATEGY. FOR THE SECOND ANCHOR, THE SHUTTLING SUTURE DE-THREADED DURING REPAIR STITCH SHUTTLING, PREVENTING KNOTLESS FIXATION. THE SURGEON COMPLETED THE CASE BY TYING KNOTS USING THE ANCHOR, WHICH WAS NOT THE PREFERRED TECHNIQUE, AND OPENED AN ADDITIONAL AR-8991CP DX KNOTLESS FIBERTAK IMPLANT KIT TO FINISH THE REPAIR. THE SURGERY WAS DELAYED APPROXIMATELY 20 MINUTES. I

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23757315 ↗
• MalfunctionOct 15, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON 10/03/2025, A SALES REPRESENTATIVE REPORTED VIA PHONE THAT AN AR-8991CP DX KNOTLESS FIBERTAK IMPLANT KITS INSERTER TIP POPPED OFF. THIS OCCURRED DURING A LATERAL LIGAMENT REPAIR ON (B)(6) 2025 WHEN THE TIP OF THE INSERTER POPPED OFF, THE ANCHOR REMAINED IN THE PATIENT, AND THE INSERTER TIP WAS ABLE TO BE RETRIEVED. THERE WAS A DELAY OF ABOUT 30 SECONDS, WHICH DID NOT REQUIRE ADDITIONAL ANESTHESIA. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 23300098 ↗
• MalfunctionApr 22, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON (B)(6) 2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-8991CP DX KNOTLESS FIBERTAK IMPLANT KIT, WHEN OPENED, DID NOT HAVE PURPLE MARKINGS ON THE SUTURE TO INDICATE WHERE TO SHUTTLE THE SUTURE FROM. THEY GUESSED AND IMPLANTED THE IMPLANT, BUT THE ANCHOR FAILED AND PULLED OUT. ANCHOR AND SUTURE WERE REMOVED FROM THE PATIENT. THEY USED ANOTHER AR-8991CP DX KNOTLESS FIBERTAK IMPLANT KIT FROM A DIFFERENT, UNKNOWN LOT WITHOUT ANY ISSUES. NO PHOTOS WERE TAKEN OF THE COMPLAINT. THE CASE WAS DELAYED FIVE MINUTES DUE TO THE ISSUE. THIS WAS DISCOVERED DURING A LATERAL ANKLE STABILIZATION PROCEDURE ON (B)(6) 2025, WITH NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21882027 ↗