Arthrex® AR-7237-7Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00888867041769), received between Oct 9, 2023 and Aug 8, 2025 — classified as 3 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 8, 2025Break; Break

  ON 23RD JULY 2025, IT WAS REPORTED BY AN ARTHREX'S EMPLOYEE VIA EMAIL THAT 1 UNIT OF AR-2324PSLC, SUTURE ANCHOR, PEEK-SWIVELOCK® C, 4.75 X 19.1 MM, VENTED, AND 1 UNIT OF AR-7237-7, FIBERTAPE® 2 MM, BRAIDED POLYBEND SUTURE, BLUE, WAS USED TO IMPLANT BUT THE ANCHOR BROKE DURING INSERTION. THIS WAS DETECTED DURING AN ANKLE ARTHROSCOPIC LIGAMENT REPAIR AND REINFORCEMENT SURGERY ON (B)(6) 2025. THE PROCEDURE WAS SUCCESSFULLY COMPLETED BY USING ANOTHER BRAND PRODUCT. THERE WAS NO PATIENT HARM, AND NO SECONDARY PROCEDURE NEEDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22752058 ↗
• MalfunctionJul 31, 2025Device Damaged by Another Device; Device Damaged by Another Device

  ON (B)(6) 2025 - THE COMPLAINT INITIATOR INDICATED THAT UPON SECONDARY REVIEW OF THE SCORPION, THE TRAP DOOR OF THE INSTRUMENT WAS OBSERVED TO BE DAMAGED. IT WAS ALSO CLARIFIED THAT THE ISSUE WITH CUTTING THE SUTURE WAS NOT ATTRIBUTED TO THE NEEDLE BUT RATHER TO THE SCORPION INSTRUMENT.

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

  MAUDE report 22674515 ↗
• MalfunctionJun 17, 2025Break; Break

  ON 23 MAY 2025, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT AN AR-7237-7 FIBERTAPE® 2 MM, BRAIDED POLYBEND SUTURE, BLUE, BROKE INTRAOPERATIVELY. THIS WAS DISCOVERED DURING ACJ REPAIR PROCEDURE. THERE WAS NO PATIENT HARM AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A NEW FIBERTAPE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22235263 ↗
• InjurySep 19, 2024Failure to Advance; Failure to Advance

  ON (B)(6) 2024, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA EMAIL THAT AN AR-8980BC DX KNOTLESS SWIVELOCK, AN AR-8913DS MINI TIGHTROPE, AND AN AR-7237-7 FIBERTAPE COULD NOT BE EASILY IMPLANTED. THE PATIENT'S BONE WAS HARD, SO THE SURGEON TAPPED THE IMPLANTS IN WITH A MALLET TO PLACE THEM IN THE TUNNEL. THIS WAS DISCOVERED DURING A LISFRANC PROCEDURE ON (B)(6) 2024. ONE TO TWO WEEKS LATER, ON (B)(6) 2024, THE PATIENT UNDERWENT REVISION SURGERY TO HAVE ALL THE PRODUCTS EXPLANTED. THE AR-8980BC DX KNOTLESS SWIVELOCK ANCHOR HAD PULLED OUT OF THE MEDIAL CUNEIFORM BONE. THE LISFRANC LIGAMENT PLASTY PROCEDURE WAS COMPLETED USING AN AR-8913DS MINI TIGHTROPE FROM LOT NUMBER 15242118, AN AR-7237-7 FIBERTAPE FROM LOT NUMBER 15081694, AND AN AR-8922 SUTURE BUTTON FROM LOT NUMBER 15166049.

  Patient problems: Failure of Implant

  MAUDE report 20257365 ↗
• InjuryAug 7, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  ON 07/23/2023, IT WAS REPORTED BY THE PATIENT VIA PHONE THAT THE PATIENT IS HAVING A LOT OF PAIN ON THE SITE WHERE AN AR-7237-7 FIBERTAPE 2 MM, BRAIDED POLYBEND SUTURE WAS IMPLANTED IN A BROSTROM GOULD PROCEDURE ON (B)(6) 2023. SINCE THE AR-7237-7 FIBERTAPE HAS NOT HEALED CORRECTLY AFTER SURGERY AND THERE IS PAIN ON THE SITE, THE SURGEON BELIEVES IT COULD BE AN ALLERGIC REACTION TO THE AR-7237-7 FIBERTAPE AND WOULD LIKE TO CONFIRM BY BEING PROVIDED MATERIAL COMPOSITION OF THE ARTHREX PRODUCT BEFORE PLANNING A REVISION SURGERY.

  Patient problems: Pain

  MAUDE report 19929880 ↗
• InjuryJun 21, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT AFTER AN INITIAL ROTATOR CUFF SUTURE SURGERY ON (B)(6) 2019 THE PATIENT STARTED TO EXPERIENCED MAJOR PROBLEMS (REDNESS, ITCHING AND PARTIALLY OPEN AREAS) AT THE OPERATED SITE. NO FURTHER INFORMATION RECEIVED. *** UPDATE (B)(6) 29-MAY-2024: THE INITIAL SURGERY WAS PERFORMED ON (B)(6) 2019 IN (B)(6) T AND AN MEDICAL EXAMINATION WILL BE PERFORMED ON (B)(6) 2024 IN (B)(6).

  Patient problems: Itching Sensation

  MAUDE report 19589319 ↗
• MalfunctionOct 9, 2023Break; Break

  ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER: THE EVENT OCCURRED DURING A ROTATOR CUFF REPAIR SURGERY. THERE WAS NO CASE DELAY, AND ALL THE FRAGMENTS WERE RETRIEVED FROM INSIDE THE PATIENT.

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

  MAUDE report 17898862 ↗