Arthrex® AR-8934BCKRecalls & reported problems

Summary

The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 00888867380981), received between Sep 12, 2022 and Feb 16, 2026 — classified as 1 injury, 29 malfunctions.

The most frequently reported specific device problem is “Break” (18 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 30 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 16, 2026Fracture

  ON 27-JAN-2026, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT THREE AR-8934BCK 3.0MM KNOTLESS SUTURETAK ANCHORS FRACTURED AT THE MID-SHAFT DURING INSERTION. NO ADVERSE EFFECTS WERE REPORTED. THIS WAS DISCOVERED DURING AN ELBOW PROCEDURE ON (B)(6) 2026, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION WAS RECEIVED ON 03-FEB-2026: THE THREE AR-8934BCK 3.0 MM KNOTLESS SUTURETAK ANCHORS REMAIN IMPLANTED, AND ALL DETACHED FRAGMENTS WERE SUCCESSFULLY RETRIEVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED USING ANOTHER AR-8934BCK FROM THE SAME LOT. THERE WAS NO CASE DELAY, AND NO ADDITIONAL ANESTHESIA WAS REQUIRED. ADDITIONAL INFORMATION WAS RECEIVED ON 09-FEB-2026: IT WAS CLARIFIED THAT THE THREE FRACTURED AR-8934BCK 3.0 MM KNOTLESS SUTURETAK ANCHORS WERE REMOVED FROM THE PATIENT AND DO NOT REMAIN IMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24343608 ↗
• MalfunctionFeb 16, 2026Fracture

  ON (B)(6) 2026, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT THREE AR-8934BCK 3.0MM KNOTLESS SUTURETAK ANCHORS FRACTURED AT THE MID-SHAFT DURING INSERTION. NO ADVERSE EFFECTS WERE REPORTED. THIS WAS DISCOVERED DURING AN ELBOW PROCEDURE ON (B)(6) 2026, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION WAS RECEIVED ON 03-FEB-2026: THE THREE AR-8934BCK 3.0 MM KNOTLESS SUTURETAK ANCHORS REMAIN IMPLANTED, AND ALL DETACHED FRAGMENTS WERE SUCCESSFULLY RETRIEVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED USING ANOTHER AR-8934BCK FROM THE SAME LOT. THERE WAS NO CASE DELAY, AND NO ADDITIONAL ANESTHESIA WAS REQUIRED. ADDITIONAL INFORMATION WAS RECEIVED ON 09-FEB-2026: IT WAS CLARIFIED THAT THE THREE FRACTURED AR-8934BCK 3.0 MM KNOTLESS SUTURETAK ANCHORS WERE REMOVED FROM THE PATIENT AND DO NOT REMAIN IMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24343515 ↗
• MalfunctionFeb 16, 2026Fracture

  ON 27-JAN-2026, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT THREE AR-8934BCK 3.0MM KNOTLESS SUTURETAK ANCHORS FRACTURED AT THE MID-SHAFT DURING INSERTION. NO ADVERSE EFFECTS WERE REPORTED. THIS WAS DISCOVERED DURING AN ELBOW PROCEDURE ON (B)(6) 2026, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION WAS RECEIVED ON 03-FEB-2026: THE THREE AR-8934BCK 3.0 MM KNOTLESS SUTURETAK ANCHORS REMAIN IMPLANTED, AND ALL DETACHED FRAGMENTS WERE SUCCESSFULLY RETRIEVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED USING ANOTHER AR-8934BCK FROM THE SAME LOT. THERE WAS NO CASE DELAY, AND NO ADDITIONAL ANESTHESIA WAS REQUIRED. ADDITIONAL INFORMATION WAS RECEIVED ON 09-FEB-2026: IT WAS CLARIFIED THAT THE THREE FRACTURED AR-8934BCK 3.0 MM KNOTLESS SUTURETAK ANCHORS WERE REMOVED FROM THE PATIENT AND DO NOT REMAIN IMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24343440 ↗
• MalfunctionFeb 11, 2026Break

  ON 22-JAN-2026, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT (QTY. 3) OF AN AR-8934BCK KNOTLESS SUTURETAKS WERE BREAKING DOWN NEAR THE END ON THE INSERT. THIS WAS DISCOVERED DURING THE CASE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24313285 ↗
• MalfunctionFeb 11, 2026Break

  ON 22-JAN-2026, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT (QTY. 3) OF AN AR-8934BCK KNOTLESS SUTURETAKS WERE BREAKING DOWN NEAR THE END ON THE INSERT. THIS WAS DISCOVERED DURING THE CASE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24313159 ↗
• MalfunctionFeb 11, 2026Break

  ON 22-JAN-2026, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT (QTY. (B)(4) OF AN AR-8934BCK KNOTLESS SUTURETAKS WERE BREAKING DOWN NEAR THE END ON THE INSERT. THIS WAS DISCOVERED DURING THE CASE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24312940 ↗
• MalfunctionDec 1, 2025Break; Break

  ON (B)(6) 2025, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT AN AR-8934BCK 3.0MM KNOTLESS SUTURETAK EXPERIENCED AN ISSUE DURING A SURGICAL PROCEDURE. THE SURGEON USED A 2.4MM STEP DRILL TO PREPARE THE OLECRANON FOR ANCHOR INSERTION AND CYCLED THE DRILL 2¿3 TIMES. WHILE INSERTING THE ANCHOR, THE JUNCTION BETWEEN THE CORKSCREW BODY OF THE ANCHOR AND THE PORTION ENGAGED WITH THE INSERTER SNAPPED. THE ANCHOR DID NOT BREAK OFF INSIDE THE PATIENT, AND THE SURGEON WAS ABLE TO USE ANOTHER SUTURETAK TO COMPLETE THE CASE. PRIOR TO INSERTING THE REPLACEMENT ANCHOR, THE SITE WAS RE-DRILLED WITH THE 2.4MM STEP DRILL. THIS WAS DISCOVERED DURING AN ELBOW EPICONDYLITIS REPAIR PROCEDURE ON (B)(6) 2025, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION WAS RECEIVED ON 11/18/2025: THE CASE WAS COMPLETED USING A REPLACEMENT AR-8934BCK 3.0MM KNOTLESS SUTURETAK. THERE WERE NO CASE DELAY AND NO ADDITIONAL ANESTHESIA ADMINISTERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23684563 ↗
• InjurySep 15, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  ON (B)(6) 2025, A PATIENT CALLED IN AN INQUIRY ABOUT THE MATERIAL COMPOSITION FOR AR-8934BCK 3.0MM KNOTLESS SUTURETAK. THE PATIENT REPORTED THAT AFTER UNDERGOING A POST TIB TENDON TEAR REPAIR IN HER LEFT FOOT ON (B)(6) 2024, HER BONE IS NOT HEALING. SHE WAS ADVISED THAT SHE MAY BE HAVING A REACTION AND THAT THE DEVICE COULD BE REMOVED. THE PATIENT WANTS TO CONFIRM IF THERE IS ANY METAL IN THE DEVICE TO DETERMINE IF SHE IS HAVING A REACTION. ADDITIONAL INFORMATION WAS PROVIDED ON 08/22/2025 VIA PHONE WHERE IT WAS STATED THE PATIENT HAS BEEN EXPERIENCING ALOT OF PAIN IN THE ANCHOR SITE. TWO MRIS HAVE CONFIRMED THE BONE AROUND THE ANCHOR SITE ITSELF HAS NOT HEALED. THE PATIENT HAS ALSO HAD MILD SWELLING IN THE TENDON GOING UP THE BACK OF HER FOOT INTO THE CALF. AN MRI TAKEN ON (B)(6) 2025 PRESENTED METALLIC ARTIFACTS. THE MRI SUGGESTED A POSSIBLE INFECTION; HOWEVER, BLOODWORK DOES NOT SUGGEST AN INFECTION. IT WAS MENTIONED THAT THE SURGEON SUGGESTED THE PATIENT MAY HAVE (CRPS) COMPLEX REGIONAL PAIN SYNDROME. THE PATIENT HAS BEEN GOING TO PHYSICAL THERAPY SINCE THE FIRST WEEK OF (B)(6) 2025. THE SURGEON DID REDUCE THE NAVICULAR BONE. THE BONE SURROUNDING THE ANCHOR ITSELF IS WHAT IS NO

  Patient problems: Foreign Body Reaction; Pain

  MAUDE report 23051770 ↗
• MalfunctionAug 13, 2025Break; Break

  ON 07/28/2025, A SALES REPRESENTATIVE REPORTED VIA (B)(4) THAT (2) AR-8934BCK 3.0MM KNOTLESS SUTURETAKS BROKE. THIS OCCURRED DURING A CASE ON (B)(6) 2025. WHEN THE SURGEON WENT TO ADVANCE THE SUTURETAK THE ANCHORS BROKE BACK-TO-BACK. THEY WERE ABLE TO REMOVE THEM AND REPLACE IT WITH ANOTHER. THERE WERE NO ADVERSE EFFECTS TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22792919 ↗
• MalfunctionAug 13, 2025Break; Break

  ON 07/28/2025, A SALES REPRESENTATIVE REPORTED VIA (B)(4) THAT (2) AR-8934BCK 3.0MM KNOTLESS SUTURETAKS BROKE. THIS OCCURRED DURING A CASE ON (B)(6) 2025. WHEN THE SURGEON WENT TO ADVANCE THE SUTURETAK THE ANCHORS BROKE BACK-TO-BACK. THEY WERE ABLE TO REMOVE THEM AND REPLACE IT WITH ANOTHER. THERE WERE NO ADVERSE EFFECTS TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22792757 ↗
• MalfunctionJul 31, 2025Break; Break

  ON 07/10/2025, A SALES REPRESENTATIVE REPORTED VIA PHONE THAT AN AR-8934BCK 3.0MM KNOTLESS SUTURETAK ENCOUNTERED BREAKAGE AT THE END OF THE ANCHOR UPON INSERTION IN THE DRILL HOLE. ALL PIECES WERE RETRIEVED FROM THE PATIENT, AND A REPLACEMENT AR-8934BCK 3.0MM KNOTLESS SUTURETAK FROM THE SAME LOT WAS USED TO COMPLETE THE CASE. THERE WAS A SLIGHT DELAY OF ONE MINUTE TO REDRILL, AND NO ADDED ANESTHESIA WAS ADMINISTERED TO THE PATIENT. THIS OCCURRED DURING A NIRSCHL LATERAL EPICONDYLITIS PROCEDURE ON (B)(6) 2025, WITH NO REPORTED PATIENT HARM.

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

  MAUDE report 22676478 ↗
• MalfunctionJul 8, 2025Break; Break

  ON 06/11/2025, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT THE TOP PORTION OF AN AR-8934BCK 3.0 MM KNOTLESS SUTURETAK IMPLANT BROKE INTO PIECES WHEN THE SURGEON SHUTTLED THE KNOTLESS MECHANISM. A REPLACEMENT IMPLANT WAS USED TO COMPLETE THE PROCEDURE, AND NO PATIENT HARM WAS REPORTED. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2025. ADDITIONAL INFORMATION WAS RECEIVED ON 06/24/2025: THIS OCCURRED DURING AN ELBOW EPICONDYLITIS PROCEDURE ON (B)(6) 2025. ALL PIECES OF THE BROKEN IMPLANT WERE RETRIEVED FROM THE PATIENT. THERE WAS NO CASE DELAY, AND NO ADDED ANESTHESIA WAS ADMINISTERED. NO ADVERSE EFFECTS REPORTED ON OR AFTER THE SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22441479 ↗
• MalfunctionJun 17, 2025Defective Device; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem

  ON 05/23/2025, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA (B)(4) THAT AN AR-8934BCK KNOTLESS SUTURETAK ANCHOR MALFUNCTIONED. THIS WAS DISCOVERED DURING THE CASE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22236710 ↗
• MalfunctionMay 21, 2025Break; Break

  ON 04/28/2025, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT AN AR-8934BCK 3.0MM KNOTLESS SUTURETAK BROKE DURING USE. AFTER PREPARING THE DRILL HOLE WITH A 2.4MM DRILL FOR THE 3.0MM ANCHOR, THE SURGEON TAPPED THE ANCHOR LIGHTLY TWICE AND OBSERVED THAT THE UPPER PORTION OF THE ANCHOR BODY HAD BROKEN. NO FRAGMENTS FELL INTO THE PATIENT, AND ALL BROKEN PIECES WERE SUCCESSFULLY RETRIEVED. THE CASE WAS COMPLETED WITH A NEW ANCHOR WITHOUT ISSUES. THIS WAS DISCOVERED DURING A LATERAL EPICONDYLITIS AND TENDON REPAIR PROCEDURE ON (B)(6) 2025, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22061121 ↗
• MalfunctionMay 5, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON 04/07/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-8934BCK KNOTLESS SUTURETAK 3.0MM WAS USED TO REPAIR A DELTOID. DURING THE CONVERSION OF THE KNOTLESS MECHANISM, ONE ANCHOR PULLED OUT AND SPLIT IN HALF. NO REPORTED PIECES BROKE OFF INSIDE THE PATIENT. A HARD BONE DRILL WAS UTILIZED. THE FIRST ANCHOR CONVERTED SUCCESSFULLY, BUT THE SECOND BROKE IN HALF, WHILE THE THIRD FUNCTIONED SUCCESSFULLY. ALL THREE ANCHORS BELONGED TO THE SAME LOT. THIS WAS DISCOVERED DURING A DELTOID REPAIR PROCEDURE ON (B)(6) 2025, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21962955 ↗
• MalfunctionOct 16, 2024Break; Break

  ADDITIONAL INFORMATION RECEIVED ON 10/9/2024: ALL THE BROKEN FRAGMENTS WERE REMOVED. THE CASE WAS COMPLETED USING AN AR-7220 FIBERWIRE. THE CASE WAS DELAYED FIFTEEN MINUTES WITHOUT ADDITIONAL ANESTHESIA.

  Patient problems: Insufficient Information

  MAUDE report 20463966 ↗
• MalfunctionOct 16, 2024Break; Break

  ON 10/4/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT TWO AR-8934BCK 3.0MM KNOTLESS SUTURETAK ANCHORS BROKE DURING INSERTION. THIS WAS DISCOVERED DURING A DELTOID REPAIR PROCEDURE ON (B)(6) 2024.

  Patient problems: Insufficient Information

  MAUDE report 20463686 ↗
• MalfunctionMay 24, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON (B)(6) 2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-8934BCK KNOTLESS SUTURETAK ANCHOR PULLED OUT OF BONE DURING TENSIONING. THIS WAS DISCOVERED DURING A KIDNER PROCEDURE ON (B)(6) 2024. ADDITIONAL INFORMATION RECEIVED 4/30/2024: THE CASE WAS COMPLETED USING AN AR-8981BCTJ-CP DX KNOTLESS SWIVELOCK. SINCE THIS WAS A KIDNER PROCEDURE, MOST OF THE CORTICAL BONE WAS REMOVED. THE BONE QUALITY, WHEN DRILLED AFTER THE CORTICAL BONE WAS REMOVED, WAS SOFT. THE CASE WAS DELAYED ABOUT FIVE MINUTES.

  Patient problems: Insufficient Information

  MAUDE report 19397398 ↗
• MalfunctionMay 20, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON 4/23/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-8934BCK KNOTLESS SUTURETAK FAILED. THIS WAS DISCOVERED DURING AN ERBC REPAIR PROCEDURE ON (B)(6) ADDITIONAL INFORMATION RECEIVED ON 5/6/2024: AFTER THE PROPER HOLE WAS DRILLED, THE ANCHOR WAS INSERTER; HOWEVER, IT PULLED OUT WHEN THE SHAFT WAS REMOVED. THE ANCHOR WOULD NOT DISENGAGE FROM THE SHAFT. NOTHING BROKE OFF INSIDE THE PATIENT. THE CASE WAS NOT DELAYED.

  Patient problems: Insufficient Information

  MAUDE report 19350078 ↗
• MalfunctionMar 19, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON 02/28/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT (2) AR-8934BCK KNOTLESS SUTURETAK SUTURES PULLED OUT OF THE ANCHORS AND FRAYED. THE SURGEON COULD NO LONGER SHUTTLE OR TENSION THE ANCHOR. THE SURGEON DRILLED OUT THE ANCHORS AND USED TO NEW ONES TO COMPLETE THE CASE. THIS WAS DISCOVERED DURING A DELTOID REPAIR PROCEDURE ON (B)(6) 2024. ADDITIONAL INFORMATION PROVIDED 3/5/24: THE 3.0MM SUTURETAK DISPOSABLE KIT WAS USED TO PREPARE THE BONE SOCKET. THE PATIENT HAD GOOD BONE QUALITY. THE CASE WAS SLIGHTLY DELAYED BUT BY NO MORE THAN 5 MINUTES. ADDITIONAL ANESTHESIA WAS NOT ADMINISTERED. THE PATIENT DID NOT SUFFER ANY NEGATIVE EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18934644 ↗
• MalfunctionMar 19, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON 02/28/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT (2) AR-8934BCK KNOTLESS SUTURETAK SUTURES PULLED OUT OF THE ANCHORS AND FRAYED. THE SURGEON COULD NO LONGER SHUTTLE OR TENSION THE ANCHOR. THE SURGEON DRILLED OUT THE ANCHORS AND USED TO NEW ONES TO COMPLETE THE CASE. THIS WAS DISCOVERED DURING A DELTOID REPAIR PROCEDURE ON (B)(6) 2024. ADDITIONAL INFORMATION PROVIDED 3/5/24: THE 3.0MM SUTURETAK DISPOSABLE KIT WAS USED TO PREPARE THE BONE SOCKET. THE PATIENT HAD GOOD BONE QUALITY. THE CASE WAS SLIGHTLY DELAYED BUT BY NO MORE THAN 5 MINUTES. ADDITIONAL ANESTHESIA WAS NOT ADMINISTERED. THE PATIENT DID NOT SUFFER ANY NEGATIVE EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18934348 ↗
• MalfunctionMar 19, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON 2/28/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AR-8934BCK KNOTLESS SUTURETAK PULLED OUT. THE ANCHOR REMAINED IN BONE, BUT THE SUTURES PULLED THROUGH. THE CASE WAS COMPLETED USING FIBEWIRE TO COMPLETE THE CASE. THIS WAS DISCOVERED DURING AN ATFL PROCEDURE ON (B)(6) 2024. ADDITIONAL INFORMATION PROVIDED 3/4/24: THE 3.0 SUTURETAK DISPOSABLE KIT WAS USED TO PREPARE THE BONE SOCKET. THE PATIENT'S BONE QUALITY WAS GOOD. NO DELAY IN THE CASE. ADDITIONAL ANESTHESIA WAS NOT NEEDED. THE PATIENT DIDN'T SUFFER NEGATIVE EFFECTS.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18934259 ↗
• MalfunctionJan 5, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON 12/8/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE THAT AN AR-8934BCK 3.0MM KNOTLESS SUTURETAK ANCHOR PULLED OUT OF BONE AND COULD NOT BE IMPLANTED AGAIN. A SOFT 2.4 MM BONE DRILL WAS USED, AND THE ANCHOR WOULD HOLD THE PATIENT IN PLACE. THE CASE WAS COMPLETED USING A PRODUCT FROM ANOTHER MANUFACTURER. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2023. NOTHING BROKE OFF INSIDE THE PATIENT, AND THIS WAS DISCOVERED DURING AN ELBOW PROCEDURE.

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

  MAUDE report 18452831 ↗
• MalfunctionDec 14, 2023Break; Break

  ON 11/16/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-8934BCK KNOTLESS SUTURETAK BROKE DURING INSERTION. THIS WAS DISCOVERED DURING A PERONEAL REPAIR PROCEDURE ON (B)(6) 2023. NO FURTHER INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION RECEIVED ON 11/17/2023: THE CASE WAS COMPLETED BY REMOVING ALL THE BROKEN FRAGMENTS AND USING A PRODUCT FROM ANOTHER MANUFACTURER. THE CASE WAS NOT DELAYED, AND NO ADDITIONAL ANESTHESIA WAS ADMINISTERED. THE PATIENT SUFFERED NO NEGATIVE EFFECTS ON OR AFTER THE SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18331092 ↗
• MalfunctionFeb 16, 2023Break

  ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-8934BCK KNOTLESS SUTURETAK ANCHOR BROKE IN HALF DURING INSERTION. THIS WAS DISCOVERED DURING A LATERAL ANKLE STABILIZATION PROCEDURE ON (B)(6) 2023.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16385100 ↗