Arthrex® AR-8990STRecalls & reported problems

Summary

The FDA's MAUDE database contains 66 adverse event reports that list this exact device (DI 00888867301054), received between Apr 22, 2020 and Jul 31, 2026 — classified as 7 injuries, 59 malfunctions.

The most frequently reported specific device problem is “Break” (30 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 66 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 31, 2026Device Dislodged or Dislocated

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50099896 ↗
• MalfunctionFeb 18, 2026Break

  ON 02-FEB-2026, AN ARTHREX SUBSIDIARY EMPLOYEE REPORTED VIA EMAIL THAT THE TIP OF AN AR-8990ST FIBERTAK DX SUTURE ANCHOR BROKE DURING INSERTION INTO THE BONE. THE BROKEN FRAGMENT WAS RETRIEVED WITHOUT ISSUE. THE EVENT OCCURRED DURING A PROCEDURE ON (B)(6) 2026. THERE WAS NO SIGNIFICANT CASE DELAY, NO ADDITIONAL ANESTHESIA ADMINISTERED, AND NO PATIENT HARM REPORTED. ADDITIONAL INFORMATION WAS RECEIVED ON 05-FEB-2026: THE PREVIOUSLY REPORTED ISSUE INVOLVING A BROKEN ANCHOR WAS NOT APPLICABLE TO THIS EVENT. IN THIS CASE, THE DAMAGE OCCURRED SOLELY TO THE INSERTER TIP DURING SURGERY, NOT THE AR-8990ST FIBERTAK DX SUTURE ANCHOR ITSELF. THE ANCHOR REMAINED FULLY INTACT, WITH NO IMPACT ON THE STRENGTH OR INTEGRITY OF THE FIXATION. AS A RESULT, THE ORIGINALLY SELECTED AR-8990ST FIBERTAK DX SUTURE ANCHOR WAS SUCCESSFULLY IMPLANTED, COMPLETING THE PROCEDURE WITHOUT FURTHER ISSUES.

  Patient problems: Foreign Body In Patient

  MAUDE report 24381021 ↗
• MalfunctionDec 1, 2025Positioning Failure; Positioning Failure

  ON 11/11/2025, AN ARTHREX SUBSIDIARY EMPLOYEE REPORTED VIA EMAIL THAT AN AR-8990ST FIBERTAK DX SUTURE ANCHOR WITH 1.3 MM SUTURETAPE WAS INTENDED FOR USE DURING AN ANKLE ARTHROSCOPY PROCEDURE USING THE BROSTROM-GOULD TECHNIQUE ON (B)(6) 2025. THE PHYSICIAN INITIALLY ATTEMPTED TO USE THE FIBERTAK ANCHOR BY DRILLING WITH THE PIN INCLUDED IN THE DISPOSABLE KIT AND THEN PASSING THE ANCHOR THROUGH THE SLEEVE. HOWEVER, THE IMPLANT OR SUTURE SLEEVE DID NOT FIT PROPERLY WITH THE METALLIC HOLDER ON WHICH IT WAS MOUNTED (SEE THE ATTACHED PHOTOS). ATTEMPTS WERE MADE TO PLACE THE ANCHOR, BUT IT REMAINED TOO SUPERFICIAL AND DID NOT SEAT AGAINST THE CORTICAL BONE, WHICH IS ITS STRONGEST FIXATION POINT. SINCE PROPER FIXATION COULD NOT BE ACHIEVED, THE PHYSICIAN DECIDED TO SWITCH TO A MINI SUTURETAK 2.4 ANCHOR, WHICH RESOLVED THE ISSUE. ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2025: DURING THE PROCEDURE, AFTER ANCHOR PLACEMENT, THE ISSUE OCCURRED WHEN PULLING THE SUTURE; THE COIL DID NOT FORM CORRECTLY. SLIGHT RESISTANCE WAS NOTED DURING INSERTION. THE CASE WAS COMPLETED USING A MINI SUTURETAK ANCHOR, WHICH ONLY REQUIRED THE APPROPRIATE DRILL BIT FOR INSERTION; NO ADDITIONAL BONE PREPARATION O

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23684249 ↗
• MalfunctionOct 28, 2025Material Twisted/Bent; Material Twisted/Bent

  ON 10/14/2025, AN ARTHREX SUBSIDIARY EMPLOYEE REPORTED VIA EMAIL THAT AN AR-8990ST DX FIBERTAK HAD A BENT TIP WHEN THE SURGEON REMOVED IT FROM THE PACKAGE. THE SURGEON ATTEMPTED TO STRAIGHTEN THE TIP AND PASS IT THROUGH THE GUIDE, BUT IT BENT AGAIN DURING INSERTION AND BECAME COMPLETELY UNUSABLE. THE SURGERY WAS COMPLETED USING ANOTHER AR-8990ST DX FIBERTAK. NO SIGNIFICANT SURGICAL DELAY WAS REPORTED, NO ADDITIONAL ANESTHESIA WAS ADMINISTERED, AND NO ADVERSE PATIENT EFFECTS OCCURRED DURING OR AFTER THE PROCEDURE. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2025.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23405945 ↗
• MalfunctionAug 7, 2025Break; Break

  ON 07/18/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-8990ST SUTURE ANCHOR TIP BROKE OFF WHEN IMPLANT WAS INSERTED. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT. CASE WAS COMPLETED USING ANOTHER SUTURE ANCHOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22737452 ↗
• InjuryJul 30, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  ADDITIONAL INFORMATION WAS RECEIVED ON 08/05/2025: THE PATIENT IS APPROXIMATELY FOUR MONTHS POST-OPERATIVE AND CONTINUES TO EXPERIENCE PERSISTENT PAIN AT THE BASE OF THE THUMB. THE THUMB FREQUENTLY CREAKS AND CRACKS WITH MOVEMENT, OFTEN CAUSING NIGHTTIME PAIN THAT DISRUPTS SLEEP. THE PATIENT HAS ALSO NOTED OCCASIONAL SKIN DISCOLORATION, APPEARING BLACK AND BLUE. PHYSICAL THERAPY HAS PROVEN INEFFECTIVE AND IRRITATES THE WRIST. DESPITE THE SURGEON¿S ASSESSMENT THAT EVERYTHING APPEARS NORMAL, THE PATIENT REPORTS THAT SYMPTOMS ARE NOW WORSE THAN PRIOR TO SURGERY.

  Patient problems: Complex regional pain syndrome; Limb Pain; Loss of Range of Motion; Muscle Weakness/Atrophy; Pain; Skin Discoloration; Sleep Dysfunction

  MAUDE report 22665976 ↗
• MalfunctionApr 2, 2025Break; Break

  ON 3/7/2025, AN FDA MEDWATCH NOTIFICATION WAS RECEIVED VIA EMAIL. A FACILITY REPRESENTATIVE REPORTED THAT TWO AR-8990ST FIBERTAK DX SUTURES HAD ISSUES DURING THE PROCEDURE. THE FIRST FIBERTAK DX SUTURE BROKE, AND THE SECOND WOULD NOT SEAT. THERE WAS NO ADVERSE EFFECT ON THE PATIENT. THIS WAS DISCOVERED DURING A RIGHT ANKLE ARTHROSCOPY WITH EXTENSIVE DEBRIDEMENT, KELOID SCAR REVISION RIGHT LATERAL ANKLE, SECONDARY REPAIR RIGHT ANTERIOR TALOFIBULAR LIGAMENT, AND SECONDARY REPAIR OF THE RIGHT CALCANEOFIBULAR LIGAMENT PROCEDURE IN (B)(6) 2025. ADDITIONAL INFORMATION WAS REQUESTED ON 3/28/2025.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21753596 ↗
• MalfunctionApr 2, 2025Failure to Advance; Failure to Advance

  ON 3/7/2025, AN FDA MEDWATCH NOTIFICATION WAS RECEIVED VIA EMAIL. A FACILITY REPRESENTATIVE REPORTED THAT TWO AR-8990ST FIBERTAK DX SUTURES HAD ISSUES DURING THE PROCEDURE. THE FIRST FIBERTAK DX SUTURE BROKE, AND THE SECOND WOULD NOT SEAT. THERE WAS NO ADVERSE EFFECT ON THE PATIENT. THIS WAS DISCOVERED DURING A RIGHT ANKLE ARTHROSCOPY WITH EXTENSIVE DEBRIDEMENT, KELOID SCAR REVISION RIGHT LATERAL ANKLE, SECONDARY REPAIR RIGHT ANTERIOR TALOFIBULAR LIGAMENT, AND SECONDARY REPAIR OF THE RIGHT CALCANEOFIBULAR LIGAMENT PROCEDURE IN (B)(6) OF 2025. ADDITIONAL INFORMATION WAS REQUESTED ON 3/28/2025.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21753593 ↗
• MalfunctionJan 10, 2025Break; Break

  ON (B)(6) 2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT TWO AR-8990ST FIBERTAK DX MALFUNCTIONED. NO FURTHER INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION WAS RECEIVED ON 12/20/2024: THIS WAS DISCOVERED DURING AN ATFL RECONSTRUCTION PROCEDURE ON (B)(6) 2024. BOTH FIBERTAK INSERTER TIPS BROKE DURING INSERTION. ALL BROKEN FRAGMENTS WERE REMOVED. THE CASE WAS COMPLETED USING A NEW AR-8990ST FIBERTAK DX. THE CASE WAS DELAYED FIVE MINUTES WITHOUT ADDITIONAL ANESTHESIA.

  Patient problems: Insufficient Information

  MAUDE report 21124945 ↗
• MalfunctionJan 10, 2025Break; Break

  ON (B)(6) 2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT TWO AR-8990ST FIBERTAK DX MALFUNCTIONED. NO FURTHER INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION WAS RECEIVED ON 12/20/2024: THIS WAS DISCOVERED DURING AN ATFL RECONSTRUCTION PROCEDURE ON (B)(4)2024. BOTH FIBERTAK INSERTER TIPS BROKE DURING INSERTION. ALL BROKEN FRAGMENTS WERE REMOVED. THE CASE WAS COMPLETED USING A NEW AR-8990ST FIBERTAK DX. THE CASE WAS DELAYED FIVE MINUTES WITHOUT ADDITIONAL ANESTHESIA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21124943 ↗
• MalfunctionJan 9, 2025Break; Break

  ON 12/04/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT (QTY. 5) OF AN AR-8990ST FIBERTAK® DX SUTURE ANCHOR WITH 1.3 MM SUTURETAPE WAS RIPPED AND BROKEN OFF DURING INSERTION OF THE IMPLANT. THE SURGEON REMOVED MOST OF THE FRAGMENTS, BUT IT WAS STATED THAT METAL WAS LEFT IN THE PATIENT FROM THE INSERTER. THE CASE WAS COMPLETED SUCCESSFULLY BY USING 2 OF THE SAME PRODUCTS TO HOLD WITH A SUTURE OF NON-ARTHREX PRODUCT. THERE WAS A CASE DELAY OF 45-50 MINUTES, AND NO MEDICAL INTERVENTION OR REVISION SURGERY WAS NEEDED. THE CURRENT HEALTH STATUS OF THE PATIENT IS "GOOD." THIS WAS DISCOVERED DURING A BROSTROM ANKLE STABILITY PROCEDURE ON (B)(6) 2024.

  Patient problems: Foreign Body In Patient

  MAUDE report 21112202 ↗
• MalfunctionJan 9, 2025Break; Break

  ON 12/04/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT (QTY. 5) OF AN AR-8990ST FIBERTAK® DX SUTURE ANCHOR WITH 1.3 MM SUTURETAPE WAS RIPPED AND BROKEN OFF DURING INSERTION OF THE IMPLANT. THE SURGEON REMOVED MOST OF THE FRAGMENTS, BUT IT WAS STATED THAT METAL WAS LEFT IN THE PATIENT FROM THE INSERTER. THE CASE WAS COMPLETED SUCCESSFULLY BY USING 2 OF THE SAME PRODUCTS TO HOLD WITH A SUTURE OF NON-ARTHREX PRODUCT. THERE WAS A CASE DELAY OF 45-50 MINUTES, AND NO MEDICAL INTERVENTION OR REVISION SURGERY WAS NEEDED. THE CURRENT HEALTH STATUS OF THE PATIENT IS "GOOD." THIS WAS DISCOVERED DURING A BROSTROM ANKLE STABILITY PROCEDURE ON (B)(6) 2024.

  Patient problems: Foreign Body In Patient

  MAUDE report 21111923 ↗
• MalfunctionJan 9, 2025Break; Break

  ON 12/04/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT (QTY. 5) OF AN AR-8990ST FIBERTAK® DX SUTURE ANCHOR WITH 1.3 MM SUTURETAPE WAS RIPPED AND BROKEN OFF DURING INSERTION OF THE IMPLANT. THE SURGEON REMOVED MOST OF THE FRAGMENTS, BUT IT WAS STATED THAT METAL WAS LEFT IN THE PATIENT FROM THE INSERTER. THE CASE WAS COMPLETED SUCCESSFULLY BY USING 2 OF THE SAME PRODUCTS TO HOLD WITH A SUTURE OF NON-ARTHREX PRODUCT. THERE WAS A CASE DELAY OF 45-50 MINUTES, AND NO MEDICAL INTERVENTION OR REVISION SURGERY WAS NEEDED. THE CURRENT HEALTH STATUS OF THE PATIENT IS "GOOD." THIS WAS DISCOVERED DURING A BROSTROM ANKLE STABILITY PROCEDURE ON (B)(6) 2024.

  Patient problems: Foreign Body In Patient

  MAUDE report 21111803 ↗
• MalfunctionJan 9, 2025Break; Break

  ON 12/04/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT (QTY. 5) OF AN AR-8990ST FIBERTAK® DX SUTURE ANCHOR WITH 1.3 MM SUTURETAPE WAS RIPPED AND BROKEN OFF DURING INSERTION OF THE IMPLANT. THE SURGEON REMOVED MOST OF THE FRAGMENTS, BUT IT WAS STATED THAT METAL WAS LEFT IN THE PATIENT FROM THE INSERTER. THE CASE WAS COMPLETED SUCCESSFULLY BY USING 2 OF THE SAME PRODUCTS TO HOLD WITH A SUTURE OF NON-ARTHREX PRODUCT. THERE WAS A CASE DELAY OF 45-50 MINUTES, AND NO MEDICAL INTERVENTION OR REVISION SURGERY WAS NEEDED. THE CURRENT HEALTH STATUS OF THE PATIENT IS "GOOD." THIS WAS DISCOVERED DURING A BROSTROM ANKLE STABILITY PROCEDURE ON (B)(6) 2024.

  Patient problems: Foreign Body In Patient

  MAUDE report 21111795 ↗
• MalfunctionJan 9, 2025Break; Break

  ON 12/04/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT (QTY. 5) OF AN AR-8990ST FIBERTAK® DX SUTURE ANCHOR WITH 1.3 MM SUTURETAPE WAS RIPPED AND BROKEN OFF DURING INSERTION OF THE IMPLANT. THE SURGEON REMOVED MOST OF THE FRAGMENTS, BUT IT WAS STATED THAT METAL WAS LEFT IN THE PATIENT FROM THE INSERTER. THE CASE WAS COMPLETED SUCCESSFULLY BY USING 2 OF THE SAME PRODUCTS TO HOLD WITH A SUTURE OF NON-ARTHREX PRODUCT. THERE WAS A CASE DELAY OF 45-50 MINUTES, AND NO MEDICAL INTERVENTION OR REVISION SURGERY WAS NEEDED. THE CURRENT HEALTH STATUS OF THE PATIENT IS "GOOD." THIS WAS DISCOVERED DURING A BROSTROM ANKLE STABILITY PROCEDURE ON (B)(6) 2024.

  Patient problems: Foreign Body In Patient

  MAUDE report 21111598 ↗
• MalfunctionNov 13, 2024Fitting Problem; Fitting Problem

  ON 10/29/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT (QTY. 2) OF AN AR-8990ST FIBERTAK DX SUTURE ANCHORS WERE INSERTED AND THEN PULLED OUT WHEN ATTEMPTING TO SET. THIS WAS DISCOVERED DURING A BROSTROM REPAIR/ATFL RECONSTRUCTION WITH INTERNALBRACE ON (B)(6) 2024. THE CASE WAS COMPLETED USING 2.2 CORKSCREWS INSTEAD OF DX FIBERTAKS. ADDITIONAL INFORMATION RECEIVED ON 11/1/2024: NOTHING BROKE INSIDE THE PATIENT, THE SHAFT OF THE FIBERTAK ONLY BENT. THE CASE WAS COMPLETED USING ANOTHER AR-1318FT AND AN AR-1318FT CORKSCREW FT. THE CASE WAS DELAYED TEN MINUTES WITHOUT ADDITIONAL ANESTHESIA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20678117 ↗
• MalfunctionNov 11, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON 10/29/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT (QTY. 2) OF AN AR-8990ST FIBERTAK DX SUTURE ANCHORS WERE INSERTED AND THEN PULLED OUT WHEN ATTEMPTING TO SET. THIS WAS DISCOVERED DURING A BROSTROM REPAIR/ATFL RECONSTRUCTION WITH INTERNALBRACE ON (B)(6) 2024. THE CASE WAS COMPLETED USING 2.2 CORKSCREWS INSTEAD OF DX FIBERTAKS. ADDITIONAL INFORMATION RECEIVED ON 11/1/2024: NOTHING BROKE INSIDE THE PATIENT, THE SHAFT OF THE FIBERTAK ONLY BENT. THE CASE WAS COMPLETED USING ANOTHER AR-1318FT AND AN AR-1318FT CORKSCREW FT. THE CASE WAS DELAYED TEN MINUTES WITHOUT ADDITIONAL ANESTHESIA.

  Patient problems: Insufficient Information

  MAUDE report 20652687 ↗
• MalfunctionSep 16, 2024Positioning Failure; Positioning Problem; Positioning Failure; Positioning Problem

  ON 10/01/2024 ADDITIONAL INFORMATION WAS RECEIVED BY AN ARTHREX SUBSIDIARY EMPLOYEE WHO STATED THAT "THE SURGERY WAS A LATERAL ANKLE INSTABILITY WITH ARTHROSCOPY. THE ANCHOR WAS DISCARDED IN ACCORDANCE WITH THE HOSPITAL'S PROTOCOL. THE ANCHOR THAT WAS DAMAGED WAS INSERTED INTO THE FIBULA, AND AS SOON AS WE PULLED TO TEST THE ANCHOR IT CAME OUT, DIDN'T STICK, WE REASSEMBLED THE ANCHOR AND TRIED TO USE IT AGAIN, BUT THE WIRE WAS DAMAGED AND BROKE WITH THE SECOND ATTEMPT, MAKING IT NECESSARY TO OPEN ANOTHER ANCHOR. "

  Patient problems: Insufficient Information

  MAUDE report 20226913 ↗
• MalfunctionSep 5, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON 8/12/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT TWO AR-8990ST FIBERTAK DX ANCHORS PULLED OUT. THIS WAS DISCOVERED DURING A BROSTROM PROCEDURE. EVERYTHING WAS REMOVED FROM THE PATIENT BEFORE COMPLETING THE PROCEDURE.

  Patient problems: Insufficient Information

  MAUDE report 20146061 ↗
• MalfunctionSep 5, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON (B)(6) 2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT TWO AR-8990ST FIBERTAK DX ANCHORS PULLED OUT. THIS WAS DISCOVERED DURING A BROSTROM PROCEDURE. EVERYTHING WAS REMOVED FROM THE PATIENT BEFORE COMPLETING THE PROCEDURE.

  Patient problems: Insufficient Information

  MAUDE report 20146004 ↗
• MalfunctionAug 15, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON 8/12/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-8990ST FIBERTAK DX SUTURE PULLED OUT. THE SURGEON ATTRIBUTED THE ANCHOR PULLING OUT TO THE PATIENT'S BONE BEING TOO HARD FOR THE ANCHOR TO SET PROPERLY AND SUBSEQUENTLY REQUESTED THE 1.6MM DRILL BIT. THE AR-8990ST FIBERTAK DX SUTURE WAS UNDAMAGED, SO THE SURGEON RELOADED IT AND REDRILLED IT WITH THE 1.6 MM DRILL, IMPLANTED THE ANCHOR, AND IT PULLED OUT AGAIN. THE CASE WAS COMPLETED USING AN AR-8991 KNOTLESS FIBERTAK DX. THIS WAS DISCOVERED DURING AN ELBOW EPICONDYLITIS DEBRIDEMENT AND REPAIR PROCEDURE.

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

  MAUDE report 19994304 ↗
• MalfunctionJun 25, 2024Material Frayed; Use of Device Problem; Material Frayed; Use of Device Problem

  ON (B)(6) 2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-8990ST FIBERTAK DX SUTURES WOULD NOT SIDE AFTER IMPLANTATION. WHEN THE SUTURE FINALLY FREED UP, IT WAS CUT IN HALF AND FRAYED. THE INSERTER WAS NOT BROKEN IN THE FORK TIP AREA AND THE BONE WAS NOT TOO HARD WHEN DRILLING. THIS WAS DISCOVERED DURING A PROCEDURE. ADDITIONAL INFORMATION RECEIVED ON 6/5/2024: THIS WAS DISCOVERED DURING A BROSTROM REPAIR PROCEDURE ON (B)(6) 2024. THE CASE WAS COMPLETED USING ANOTHER AR-8990ST FIBERTAK DX. THE SHEATH WAS NOT RETRIEVED. THE CASE WAS DELAYED FIVE MINUTES WITHOUT ADDITIONAL ANESTHESIA.

  Patient problems: Foreign Body In Patient; Insufficient Information

  MAUDE report 19607132 ↗
• MalfunctionJun 20, 2024Failure to Advance; Failure to Advance

  ON 11/22/2022, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT AN AR-8990ST FIBERTAK DX SUTURE ANCHOR INSERTER DID NOT PASS THROUGH WHEN INSERTING AND THE INSERTER SHAFT BENT AFTER IT WAS TAPPED IN. SURGEON USED A NEW PRODUCT AND CASE WAS COMPLETED. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2022. ADDITIONAL INFORMATION RECEIVED ON 11/28/2022: THIS WAS DISCOVERED DURING A LATERAL LIGAMENT REPAIR OF THE ANKLE JOINT AND COMPLETED USING AN AR-8990ST FIBERTAK DX SUTURE. THE SHAFT BENT BUT DID NOT BREAK.

  Patient problems: Insufficient Information

  MAUDE report 19579244 ↗
• MalfunctionJun 18, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED DURING AN ANKLE REPAIR THE ANCHOR WOULD NOT SET AND PULLED OUT OF THE BONE. IT WAS REMOVED AND REPLACED WITH ANOTHER AR-8990ST WITH A DIFFERENT LOT NUMBER AND THE CASE WAS COMPLETED WITH NO FURTHER ISSUES.

  Patient problems: Insufficient Information

  MAUDE report 19558582 ↗
• MalfunctionJun 10, 2024Break; Break

  ON 05/14/2024 IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA E-MAIL THAT AN AR-8990ST FIBERTAK® DX SUTURE ANCHOR METAL PART OF THE CROTCH HOLDING THE SOFT ANCHOR BROKE THIS OCCURRED DURING AN ATFL TEAR REPAIR. THE METAL PART OF THE CROTCH HOLDING THE SOFT ANCHOR BROKE AND REMAINED IN THE FIBULA. THE SURGERY WAS COMPLETED WITHOUT TREATMENT BECAUSE IT WAS SO LARGE THAT IT COULD NOT BE SEEN EVEN IN THE IMAGE. THE PROCEDURE WAS COMPLETED WITH THE PRODUCT. ADDITIONAL INFORMATION RECEIVED ON 5/21/2021: ALTHOUGH THERE ARE NO OBVIOUS NEGATIVE EFFECTS ON THE PATIENT, A SMALL PIECE OF THE DRIVER MAY REMAIN. HOWEVER, IT HAS BEEN REPORTED THAT X-RAYS WERE UNABLE TO CONFIRM THAT THE BROKEN PIECES REMAINED IN THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 19497982 ↗