Arthrex® AR-8934BCSTRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00888867375116), received between Oct 3, 2022 and Mar 16, 2026 — classified as 4 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (4 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryMar 16, 2026Patient Device Interaction Problem

  ON (B)(6) 2026, THE PATIENT REPORTED VIA PHONE THAT THEY UNDERWENT A LEFT ANKLE ARTHROSCOPY WITH BROSTROM REPAIR AND INTERNAL BRACE ON (B)(6) 2025. APPROXIMATELY FIVE WEEKS POSTOPERATIVELY, THEY BEGAN EXPERIENCING A SENSATION OF SOMETHING ¿POKING THROUGH THE SKIN,¿ IRRITATION, DECREASED RANGE OF MOTION, AND SHARP PAIN DURING WEIGHT-BEARING. THE PATIENT STATED THEY INITIATED PHYSICAL THERAPY ON (B)(6) 2025 AND HAVE SINCE EXPERIENCED A PROGRESSIVE DECLINE IN RANGE OF MOTION. THEY RATED THEIR CURRENT PAIN AS 8¿10 OUT OF 10. THE PATIENT REPORTED THAT RECENT MRI FINDINGS SHOWED MILD BONE SWELLING AROUND THE ANCHOR, AND AVASCULAR NECROSIS WAS SUSPECTED, ALTHOUGH IT IS NOT YET VISIBLE ON THE MRI. THE (B)(6) 2025 PROCEDURE WAS PERFORMED TO ADDRESS CHRONIC LEFT ANKLE INSTABILITY FOLLOWING A SEVERE SPRAIN THAT HAD NOT HEALED ADEQUATELY. THE PATIENT ALSO REPORTED BEING INSTRUCTED NOT TO USE ASSISTIVE DEVICES SUCH AS CRUTCHES OR A BRACE DURING RECOVERY. AT THE TIME OF THE REPORT, NO REVISION SURGERY IS PLANNED. THE ARTHREX IMPLANTS IMPLANTED IN THE LEFT ANKLE ARTHROSCOPY WITH BROSTROM REPAIR AND INTERNAL BRACE ON (B)(6) 2025 INCLUDE AR-1788J-CP INTERNALBRACE IMPLANT SYSTEM, LIGAMENT AUGMENTATI

  Patient problems: Foreign Body In Patient; Loss of Range of Motion; Pain; Swelling/ Edema

  MAUDE report 24605341 ↗
• InjuryMar 16, 2026Patient Device Interaction Problem

  ON (B)(6) 2026, THE PATIENT REPORTED VIA PHONE THAT THEY UNDERWENT A LEFT ANKLE ARTHROSCOPY WITH BROSTROM REPAIR AND INTERNAL BRACE ON (B)(6) 2025. APPROXIMATELY FIVE WEEKS POSTOPERATIVELY, THEY BEGAN EXPERIENCING A SENSATION OF SOMETHING ¿POKING THROUGH THE SKIN,¿ IRRITATION, DECREASED RANGE OF MOTION, AND SHARP PAIN DURING WEIGHT-BEARING. THE PATIENT STATED THEY INITIATED PHYSICAL THERAPY ON (B)(6) 2025 AND HAVE SINCE EXPERIENCED A PROGRESSIVE DECLINE IN RANGE OF MOTION. THEY RATED THEIR CURRENT PAIN AS 8¿10 OUT OF 10.THE PATIENT REPORTED THAT RECENT MRI FINDINGS SHOWED MILD BONE SWELLING AROUND THE ANCHOR, AND AVASCULAR NECROSIS WAS SUSPECTED, ALTHOUGH IT IS NOT YET VISIBLE ON THE MRI. THE (B)(6) 2025 PROCEDURE WAS PERFORMED TO ADDRESS CHRONIC LEFT ANKLE INSTABILITY FOLLOWING A SEVERE SPRAIN THAT HAD NOT HEALED ADEQUATELY. THE PATIENT ALSO REPORTED BEING INSTRUCTED NOT TO USE ASSISTIVE DEVICES SUCH AS CRUTCHES OR A BRACE DURING RECOVERY. AT THE TIME OF THE REPORT, NO REVISION SURGERY IS PLANNED.THE ARTHREX IMPLANTS IMPLANTED IN THE LEFT ANKLE ARTHROSCOPY WITH BROSTROM REPAIR AND INTERNAL BRACE ON (B)(6) 2025 INCLUDE AR-1788J-CP INTERNALBRACE IMPLANT SYSTEM, LIGAMENT AUGMENTATION

  Patient problems: Foreign Body In Patient; Loss of Range of Motion; Pain; Swelling/ Edema

  MAUDE report 24605021 ↗
• MalfunctionFeb 23, 2024Detachment of Device or Device Component; Device Dislodged or Dislocated; Detachment of Device or Device Component; Device Dislodged or Dislocated

  ON 1/31/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT THE SUTURETAPE FROM AN AR-8934BCST SINGLE LOADED SUTURETAPE S-TAK ASSY PULLED OUT OF THE ANCHOR, AND THE ANCHOR REMAINED IN THE BONE. THIS WAS DISCOVERED DURING A KIDNER PROCEDURE. NOTHING BROKE INSIDE THE PATIENT, AND THE CASE WAS COMPLETED SUCCESSFULLY. THE CASE WAS NOT DELAYED, AND ADDITIONAL ANESTHESIA WAS NOT NEEDED. THE PATIENT SUFFERED NO NEGATIVE EFFECTS ON OR AFTER THE PROCEDURE.

  Patient problems: Foreign Body In Patient

  MAUDE report 18768688 ↗
• MalfunctionFeb 14, 2024Failure to Advance; Failure to Advance

  ADDITIONAL INFORMATION RECONCEIVED ON 2/8/2024: THE CASE WAS NOT DELAYED, AND NO ADDITIONAL ANESTHESIA WAS NEEDED. THE PATIENT SUFFERED NO NEGATIVE EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18702778 ↗
• InjuryJul 24, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  ON 06/27/2023, IT WAS REPORTED BY A RELATIVE OF A PATIENT, VIA PHONE, THAT THE PATIENT IS EXPERIENCING A REACTION 3 WEEKS AFTER UNDERGOING A RIGHT DE ROTATIONAL FEMORAL OSTEOTOMY WITH ALLOGRAFT AND MPSL RECONSTRUCTION WITH ALLOGRAFT ON (B)(6) 2023 IN WHICH (2) AR-8934BCST SUTURE TAPES, AN AR-8719MXDS-2015 DYNANITE STAPLE, AND AN AR-4030P-07 PEEK INTERFERENCE SCREW WERE IMPLANTED. THE PATIENT WAS ADMITTED TO THE HOSPITAL AFTER EXPERIENCING A BREAKOUT OF HIVES. THE PATIENT IS BEING TREATED WITH STEROIDS AND OTHER ANTIHISTAMINES THAT ARE KEEPING HER STABLE. THE PATIENT IS AWAITING ALLERGY TESTING. THERE WAS NO ADDITIONAL INFORMATION PROVIDED ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 17377278 ↗
• InjuryJul 24, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  ON (B)(6) 2023, IT WAS REPORTED BY A RELATIVE OF A PATIENT, VIA PHONE, THAT THE PATIENT IS EXPERIENCING A REACTION 3 WEEKS AFTER UNDERGOING A RIGHT DE ROTATIONAL FEMORAL OSTEOTOMY WITH ALLOGRAFT AND MPSL RECONSTRUCTION WITH ALLOGRAFT ON (B)(6) 2023 IN WHICH (2) AR-8934BCST SUTURE TAPES, AN AR-8719MXDS-2015 DYNANITE STAPLE, AND AN AR-4030P-07 PEEK INTERFERENCE SCREW WERE IMPLANTED. THE PATIENT WAS ADMITTED TO THE HOSPITAL AFTER EXPERIENCING A BREAKOUT OF HIVES. THE PATIENT IS BEING TREATED WITH STEROIDS AND OTHER ANTIHISTAMINES THAT ARE KEEPING HER STABLE. THE PATIENT IS AWAITING ALLERGY TESTING. THERE WAS NO ADDITIONAL INFORMATION PROVIDED ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 17377040 ↗
• MalfunctionOct 3, 2022Break

  IT WAS REPORTED ON 09/16/2022 BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-8934BCST SUTURE TAPE ASSEMBLY ANCHOR BROKE WHILE BEING MALLETED IN. THIS WAS DISCOVERED DURING A CASE AND BROKE INSIDE THE JOINT SPACE.

  Patient problems: Insufficient Information

  MAUDE report 15534088 ↗