Arthrex® AR-8991Recalls & reported problems

Summary

The FDA's MAUDE database contains 61 adverse event reports that list this exact device (DI 00888867377295), received between Oct 17, 2022 and Mar 2, 2026 — classified as 1 injury, 60 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (21 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 25 most recent of 61 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 2, 2026Device Dislodged or Dislocated

  ON 02/11/2026, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT THREE AR-8991 FIBERTAK DX ANCHORS PULLED OUT. THE CASE WAS COMPLETED USING 2.4 MM SUTURETAKS. THE ISSUE WAS DISCOVERED DURING A KNOTLESS BROSTRÖM AND DELTOID REPAIR PROCEDURE ON (B)(6) 2026. ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2026: THE THREE AR-8991 FIBERTAK DX ANCHORS WERE REMOVED FROM THE PATIENT, AND NO COMPONENTS FRACTURED OR REMAINED INSIDE THE SURGICAL SITE. THE BONE SOCKET WAS PREPARED USING THE AR-8991DS DISPOSABLES KIT FOR THE DX KNOTLESS FIBERTAK. THE PROCEDURE WAS COMPLETED USING AN AR-1322BCST 2.4 SINGLE-LOADED SUTURETAPE S-TAK ASSEMBLY. THERE WERE NO CASE DELAY AND NO ADDITIONAL ANESTHESIA REQUIRED.

  Patient problems: Insufficient Information

  MAUDE report 24484490 ↗
• MalfunctionMar 2, 2026Device Dislodged or Dislocated

  ON 02/11/2026, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT THREE AR-8991 FIBERTAK DX ANCHORS PULLED OUT. THE CASE WAS COMPLETED USING 2.4 MM SUTURETAKS. THE ISSUE WAS DISCOVERED DURING A KNOTLESS BROSTRÖM AND DELTOID REPAIR PROCEDURE ON (B)(6) 2026. ADDITIONAL INFORMATION WAS RECEIVED ON 16-FEB-2026: THE THREE AR-8991 FIBERTAK DX ANCHORS WERE REMOVED FROM THE PATIENT, AND NO COMPONENTS FRACTURED OR REMAINED INSIDE THE SURGICAL SITE. THE BONE SOCKET WAS PREPARED USING THE AR-8991DS DISPOSABLES KIT FOR THE DX KNOTLESS FIBERTAK. THE PROCEDURE WAS COMPLETED USING AN AR-1322BCST 2.4 SINGLE-LOADED SUTURETAPE S-TAK ASSEMBLY. THERE WERE NO CASE DELAY AND NO ADDITIONAL ANESTHESIA REQUIRED.

  Patient problems: Insufficient Information

  MAUDE report 24484166 ↗
• MalfunctionMar 2, 2026Device Dislodged or Dislocated

  ON 02/11/2026, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT THREE AR-8991 FIBERTAK DX ANCHORS PULLED OUT. THE CASE WAS COMPLETED USING 2.4 MM SUTURETAKS. THE ISSUE WAS DISCOVERED DURING A KNOTLESS BROSTRÖM AND DELTOID REPAIR PROCEDURE ON (B)(6) 2026. ADDITIONAL INFORMATION WAS RECEIVED ON 16-FEB-2026: THE THREE AR-8991 FIBERTAK DX ANCHORS WERE REMOVED FROM THE PATIENT, AND NO COMPONENTS FRACTURED OR REMAINED INSIDE THE SURGICAL SITE. THE BONE SOCKET WAS PREPARED USING THE AR-8991DS DISPOSABLES KIT FOR THE DX KNOTLESS FIBERTAK. THE PROCEDURE WAS COMPLETED USING AN AR-1322BCST 2.4 SINGLE-LOADED SUTURETAPE S-TAK ASSEMBLY. THERE WERE NO CASE DELAY AND NO ADDITIONAL ANESTHESIA REQUIRED.

  Patient problems: Insufficient Information

  MAUDE report 24483988 ↗
• MalfunctionFeb 24, 2026Positioning Failure

  ON 06-FEB-2026, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT THREE AR-8991 FIBERTAK DX SUTURE ANCHORS DID NOT MAINTAIN TENSION THROUGHOUT THE RANGE OF MOTION. THE ISSUE WAS IDENTIFIED DURING A PROCEDURE ON (B)(6) 2026. NO PATIENT HARM WAS REPORTED. ADDITIONAL INFORMATION WAS RECEIVED ON 12-FEB-2026: THIS OCCURRED DURING A LATERAL EPICONDYLITIS (TENNIS ELBOW) PROCEDURE. AFTER EXPERIENCING THREE MALFUNCTIONS, THEY CONVERTED TO A DIFFERENT KNOTTED ANCHOR AND SUCCESSFULLY COMPLETED THE CASE USING AN AR-8990ST-2 FIBERTAK DX SUTURE ANCHOR, DOUBLE-LOADED. THE PROCEDURE WAS DELAYED BY APPROXIMATELY TEN MINUTES, AND NO ADDITIONAL ANESTHESIA WAS ADMINISTERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24430518 ↗
• MalfunctionFeb 24, 2026Positioning Failure

  ON 06-FEB-2026, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT THREE AR-8991 FIBERTAK DX SUTURE ANCHORS DID NOT MAINTAIN TENSION THROUGHOUT THE RANGE OF MOTION. THE ISSUE WAS IDENTIFIED DURING A PROCEDURE ON (B)(6) 2026. NO PATIENT HARM WAS REPORTED. ADDITIONAL INFORMATION WAS RECEIVED ON 12-FEB-2026: THIS OCCURRED DURING A LATERAL EPICONDYLITIS (TENNIS ELBOW) PROCEDURE. AFTER EXPERIENCING THREE MALFUNCTIONS, THEY CONVERTED TO A DIFFERENT KNOTTED ANCHOR AND SUCCESSFULLY COMPLETED THE CASE USING AN AR-8990ST-2 FIBERTAK DX SUTURE ANCHOR, DOUBLE-LOADED. THE PROCEDURE WAS DELAYED BY APPROXIMATELY TEN MINUTES, AND NO ADDITIONAL ANESTHESIA WAS ADMINISTERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24430386 ↗
• MalfunctionFeb 24, 2026Positioning Failure

  ON 06-FEB-2026, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT THREE AR-8991 FIBERTAK DX SUTURE ANCHORS DID NOT MAINTAIN TENSION THROUGHOUT THE RANGE OF MOTION. THE ISSUE WAS IDENTIFIED DURING A PROCEDURE ON (B)(6) 2026. NO PATIENT HARM WAS REPORTED. ADDITIONAL INFORMATION WAS RECEIVED ON 12-FEB-2026: THIS OCCURRED DURING A LATERAL EPICONDYLITIS (TENNIS ELBOW) PROCEDURE. AFTER EXPERIENCING THREE MALFUNCTIONS, THEY CONVERTED TO A DIFFERENT KNOTTED ANCHOR AND SUCCESSFULLY COMPLETED THE CASE USING AN AR-8990ST-2 FIBERTAK DX SUTURE ANCHOR, DOUBLE-LOADED. THE PROCEDURE WAS DELAYED BY APPROXIMATELY TEN MINUTES, AND NO ADDITIONAL ANESTHESIA WAS ADMINISTERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24430287 ↗
• MalfunctionFeb 11, 2026Device Dislodged or Dislocated

  ON 22ND JANUARY 2026, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT AR-8991 DX FIBERTAK SUTURE ANCHOR, #2 MTS W/ NDL, BATCH 15420715, HAD PULLED OUT FROM THE FIBULA BONE SOCKET DURING THE FINAL TENSIONING OF THE EXTENSOR RETINACULUM TO THE FIBULA IN A PROCEDURE PERFORMED ON THE SAME DAY.

  Patient problems: Insufficient Information

  MAUDE report 24312693 ↗
• MalfunctionFeb 9, 2026Break

  ON (B)(6) 2026, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT AR-8991 DX FIBERTAK SUTURE ANCHOR, #2 MTS W/ NDL BATCH 15455662 TIP ANCHOR INSERTER BROKE OFF DURING IMPLANTATION. THIS WAS DETECTED DURING ANKLE LIGAMENT REPAIR PROCEDURE ON (B)(6) 2026. NO FRAGMENTS RETAINED IN THE PATIENT¿S BODY AND PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: Insufficient Information

  MAUDE report 24290369 ↗
• InjuryJan 5, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER AN INITIAL SURGERY IN WHICH AN AR-8991 WAS USED, THE KNOTLESS FIBERTAK SUTURE WAS PULLED OUT OF AN OPEN WOUND THAT WOULD NOT HEAL. PART OF THE DEVICE REMAINED INSIDE THE PATIENT. NO FURTHER INFORMATION RECEIVED.

  Patient problems: Foreign Body In Patient; Impaired Healing; Insufficient Information

  MAUDE report 23960213 ↗
• MalfunctionDec 31, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  ON (B)(6) 2025, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA EMAIL THAT AN AR-8991 FIBERTAK DX MALFUNCTIONED. THE CHINESE FINGER TRAP MECHANISM FAILED TO FUNCTION AS INTENDED DURING TENSIONING, RESULTING IN THE LINE LOOSENING. THE PROCEDURE WAS COMPLETED BY USING ANOTHER AR-8991 FIBERTAK DX. NO SIGNIFICANT SURGICAL DELAY WAS REPORTED, NOTHING REMAINED IN THE PATIENT, AND NO ADDITIONAL ANESTHESIA WAS ADMINISTERED. THIS WAS DISCOVERED DURING AN ACLR PROCEDURE ON (B)(6) 2025.

  Patient problems: Insufficient Information

  MAUDE report 23934740 ↗
• MalfunctionDec 22, 2025Use of Device Problem; Use of Device Problem

  ADDITIONAL INFORMATION WAS RECEIVED ON 12/29/2025: THE ISSUE OCCURRED DURING AN ATFL INTERNALBRACE REPAIR PROCEDURE. THE SURGEON INTEGRATED THE ANCHOR WITH THE SIMPLE REPAIR STITCH AND TIED KNOTS. ALL DETACHED PIECES WERE RETRIEVED FROM THE PATIENT. AN INDIVIDUAL DX KNOTLESS FIBERTAK ANCHOR WAS OPENED AND USED IN PLACE OF THE FAULTY ONE. THE CASE WAS DELAYED BY APPROXIMATELY 20 MINUTES, AND IT IS UNCERTAIN WHETHER ADDITIONAL ANESTHESIA WAS ADMINISTERED. NO ADVERSE EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23865405 ↗
• MalfunctionDec 10, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON NOVEMBER 24, 2025, A SALES REPRESENTATIVE REPORTED VIA PHONE, THAT AN AR-8991 FIBERTAK® DX SUTURE ANCHOR BACKED OUT DURING A BROSTROM PROCEDURE ON (B)(6) 2025. THE ANCHOR DISLODGED AFTER INSERTION. THE PATIENT HAD AVERAGE BONE QUALITY, AND THE SITE WAS PREPARED USING A 1.8 MM DRILL FROM THE AR-8991DS DISPOSABLES KIT. THE EVENT CAUSED AN APPROXIMATE 30-SECOND DELAY, WITH NO ADDITIONAL ANESTHESIA REQUIRED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY, WITH NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23768223 ↗
• MalfunctionDec 10, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON NOVEMBER 24, 2025, A SALES REPRESENTATIVE REPORTED VIA PHONE THAT AN AR-8991 FIBERTAK® DX SUTURE ANCHOR BACKED OUT DURING A BROSTROM PROCEDURE ON (B)(6) 2025. THE ANCHOR DISLODGED AFTER INSERTION. THE PATIENT HAD AVERAGE BONE QUALITY, AND THE SITE WAS PREPARED USING A 1.8 MM DRILL FROM THE AR-8991DS DISPOSABLES KIT. THE EVENT CAUSED AN APPROXIMATE 30-SECOND DELAY, WITH NO ADDITIONAL ANESTHESIA REQUIRED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY, WITH NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23767844 ↗
• MalfunctionOct 16, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON 10/09/2025, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT AN AR-8991 FIBERTAK DX SUTURE ANCHOR PULLED OUT OF THE BONE WHILE THE SURGEON PASSED THE REPAIR SUTURE THROUGH THE TENDON. INITIALLY, A 1.8 MM DRILL WAS USED, BUT THEY SWITCHED TO A 1.6 MM DRILL AND USED ANOTHER ANCHOR, WHICH FUNCTIONED AS INTENDED. THE ORIGINAL ANCHOR COULD NOT BE RELOADED BECAUSE THE INSERTER BROKE, REQUIRING A SECOND AR-8991 FIBERTAK DX SUTURE ANCHOR. THIS ISSUE WAS IDENTIFIED DURING A PROCEDURE ON (B)(6) 2025. ADDITIONAL INFORMATION HAS BEEN REQUESTED ON 10/10/2025.

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

  MAUDE report 23316711 ↗
• MalfunctionSep 9, 2025Break; Break

  ON 8/19/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT TWO AR-8991 DX KNOTLESS FIBERTAK ANCHORS WERE USED ON A LIVE PATIENT DURING A PROCEDURE CONDUCTED ON A TRIAL BASIS. BOTH ANCHORS FAILED DURING USE AND COULD NOT BE SALVAGED. FORTUNATELY, THERE WAS NO HARM TO THE PATIENT AND NO SIGNIFICANT PROCEDURAL DELAY. HARD-BODY ANCHORS WERE SUBSTITUTED, AND THE PROCEDURE WAS COMPLETED WITHOUT ISSUE. ADDITIONAL INFORMATION RECEIVED ON 8/26/2025: THIS WAS DISCOVERED DURING A BROSTROM WITH INTERNAL BRACE PROCEDURE ON (B)(6) 2025. THE ANCHORS PULLED OUT WHEN TENSIONING THE KNOTLESS MECHANISM AND BROKE. ALL BROKEN FRAGMENTS WERE REMOVED FROM THE PATIENT. THE CASE WAS COMPLETED USING AN AR-1322BCST 2.4 SINGLE LOADED SUTURETAPE S-TAK ASSY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23004509 ↗
• MalfunctionSep 9, 2025Break; Break

  ON 8/19/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT TWO AR-8991 DX KNOTLESS FIBERTAK ANCHORS WERE USED ON A LIVE PATIENT DURING A PROCEDURE CONDUCTED ON A TRIAL BASIS. BOTH ANCHORS FAILED DURING USE AND COULD NOT BE SALVAGED. FORTUNATELY, THERE WAS NO HARM TO THE PATIENT AND NO SIGNIFICANT PROCEDURAL DELAY. HARD-BODY ANCHORS WERE SUBSTITUTED, AND THE PROCEDURE WAS COMPLETED WITHOUT ISSUE. ADDITIONAL INFORMATION RECEIVED ON 8/26/2025: THIS WAS DISCOVERED DURING A BROSTROM WITH INTERNALBRACE PROCEDURE ON (B)(6) 2025. THE ANCHORS PULLED OUT WHEN TENSIONING THE KNOTLESS MECHANISM AND BROKE. ALL BROKEN FRAGMENTS WERE REMOVED FROM THE PATIENT. THE CASE WAS COMPLETED USING AN AR-1322BCST 2.4 SINGLE LOADED SUTURETAPE S-TAK ASSY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23003654 ↗
• MalfunctionSep 8, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON (B)(6) 2025, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT AN AR-8991, FIBERTAK® DX SUTURE ANCHOR, KNOTLESS, VE5, WAS PULLED OUT OF THE BONE EVEN THOUGH THE CORRECT TECHNIQUE WAS FOLLOWED. THIS WAS DETECTED DURING USE IN AN UNSPECIFIED PROCEDURE ON (B)(6) 2025. ON (B)(6) 2025 - THE COMPLAINT INITIATOR REPLIED THAT THIS DETECTED DURING USE IN AN ARTHROBROSTRUM PROCEDURE ON (B)(6) 2025. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AS THE SECOND ANCHOR WORKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22997993 ↗
• MalfunctionAug 29, 2025Break; Break

  ON (B)(6) 2025, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA SEMS-07016508 THAT AN AR-8991 FIBERTAK® DX SUTURE ANCHOR, WHEN PLACED AND APPLYING TRACTION TO THE SUTURES THEY BROKE, RESULTING IN ANCHOR FAILURE.

  Patient problems: Insufficient Information

  MAUDE report 22922552 ↗
• MalfunctionAug 11, 2025Positioning Failure; Positioning Failure

  ON 07/24/2025, A DISTRIBUTOR REPORTED VIA EMAIL THAT AN AR-8991 FIBERTAK DX SUTURE ANCHOR FAILED TO DOCK DURING A PROCEDURE. THERE WAS NO DEVICE BREAKAGE, AND NO HARM WAS REPORTED TO THE PATIENT. THE CASE WAS SUCCESSFULLY COMPLETED USING A REPLACEMENT PRODUCT. THIS WAS DISCOVERED DURING AN ANKLE LIGAMENT RECONSTRUCTION PROCEDURE ON (B)(6) 2025. ADDITIONAL INFORMATION HAS BEEN REQUESTED ON 07/31/2025.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22773405 ↗
• MalfunctionJun 20, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON 5/30/2025, A DISTRIBUTOR REPORTED VIA EMAIL THAT AN AR-8991 FIBERTAK DX ANCHOR CAME OUT AND DID NOT STAY SECURE. THIS WAS DISCOVERED DURING AN ANKLE INSTABILITY PROCEDURE ON (B)(6) 2025. ADDITIONAL INFORMATION REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22298223 ↗
• MalfunctionMar 10, 2025Break; Break

  ON 02/14/2025, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT AN AR-8991 FIBERTAK DX SUTURE ANCHOR HAD THE SHUTTLE SUTURE BREAKING AS SOON AS THE SURGEON STARTED TO TENSION THE ANCHOR. THE SURGEON DID A MATTRESS STITCH AND DID NOT SEAT THE ANCHOR BEFORE TENSIONING IT. THE ANCHOR WAS LEFT IN THE FIBULA. THE CASE WAS COMPLETED SUCCESSFULLY. THIS WAS DISCOVERED DURING A BROSTROM PROCEDURE ON (B)(6) 2025, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION WAS RECEIVED ON 3/25/2025: THE BROKEN SUTURE WAS REMOVED. THE CASE WAS NOT DELAYED, AND ADDITIONAL ANESTHESIA WAS NOT NEEDED. THE CASE WAS COMPLETED USING AN AR-8990ST FIBERTAK DX SUTURE ANCHOR.

  Patient problems: Foreign Body In Patient

  MAUDE report 21558907 ↗
• MalfunctionJan 9, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON 12/12/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-8991 FIBERTAK® DX SUTURE ANCHOR PULLED OUT. THIS OCCURRED DURING A WRIST PROCEDURE ON (B)(6) 2024 AS THEY PASSED THE REPAIR STITCH THROUGH THE TENDON AND PULLED IT THROUGH THE ANCHOR IT BECAME STUCK AND WOULD NOT MOVE. AS THEY ATTEMPTED TO KEEP PULLING THE ANCHOR IT PULLED OUT. THE CASE CONTINUED USING ANOTHER ANCHOR. THERE WAS NO HARM ON THE PATIENT. THE CASE WAS DELAYED A COUPLE OF MINUTES AND DID NOT REQUIRE ADDITIONAL ANESTHESIA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21112404 ↗
• MalfunctionNov 8, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  ON 10/29/2024, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA (B)(6) THAT (QTY. 2) OF AN AR-8991 DX FIBERTAK SUTURE ANCHORS CONSTRUCT WAS BUNGED AND SLIGHTLY TANGLED DURING INSERTION. FACILITY WAS NOT ABLE TO USE AND OPENED A NEW ONE TO SUCCESSFULLY COMPLETE THE FIXATION WITH NO PATIENT HARM. THIS WAS DISCOVERED DURING THE CASE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20641815 ↗
• MalfunctionNov 8, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  ON 10/29/2024, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA (B)(4) THAT (QTY. 2) OF AN AR-8991 DX FIBERTAK SUTURE ANCHORS CONSTRUCT WAS BUNGED AND SLIGHTLY TANGLED DURING INSERTION. FACILITY WAS NOT ABLE TO USE AND OPENED A NEW ONE TO SUCCESSFULLY COMPLETE THE FIXATION WITH NO PATIENT HARM. THIS WAS DISCOVERED DURING THE CASE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20641773 ↗
• MalfunctionOct 4, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON 10/1/2024, IT WAS REPORTED BY A DISTRIBUTOR VIA EMAIL THAT AN AR-8991 FIBERTAK DX ANCHOR DOES NOT PASS WHEN CLOSING IT. WHEN THE SURGEON PULLED ON IT, IT WAS VERY HARD, AND THE ANCHOR PULLED OUT. THIS WAS DISCOVERED DURING AN ANKLE ARTHROSCOPY PROCEDURE ON (B)(6) 2024.

  Patient problems: Insufficient Information

  MAUDE report 20369940 ↗