Arthrex® AR-13250Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00888867010413), received between Apr 7, 2021 and Feb 5, 2025 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Break” (6 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 5, 2025Break; Break

  ON 01/15/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-13250 FIBERTAPE CUTTER WAS BROKEN (SEE PHOTO). NO PIECES BROKE OFF INSIDE THE PATIENT. THE CASE WAS COMPLETED SUCCESSFULLY. THIS WAS DISCOVERED DURING AN RCR PROCEDURE ON (B)(6) 2025, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION WAS RECEIVED ON 01/20/2025: THE CASE WAS COMPLETED BY OPENING ANOTHER TRAY FOR A WORKING FIBER TAPE CUTTER. THERE WAS NO CASE DELAY OR ADDED ANESTHESIA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21311648 ↗
• MalfunctionJun 10, 2024Corroded; Corroded

  ON 05/13/2024, A DISTRIBUTOR REPORTED VIA (B)(4) THAT AN AR-13250 FIBERTAPE CUTTER WAS RUSTED AND DID NOT CUT. THIS OCCURRED DURING A CASE AND HAD NO EFFECT ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19496659 ↗
• MalfunctionMay 22, 2024Defective Device; Defective Device

  ON 04/24/2024, IT WAS REPORTED BY A DISTRIBUTOR VIA (B)(4) THAT AN AR-13250 FIBERTAPE CUTTER WAS STARTING TO BREAK DOWN.

  Patient problems: Insufficient Information

  MAUDE report 19378238 ↗
• MalfunctionApr 18, 2024Break; Break

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR, THE AR-13250 WASN'T PERFORMING CORRECTLY DURING SURGERY AND THE SURGEON BROKE THE DEVICE. THE CASE WAS COMPLETED BY USING A NEW AR-13250 WITHOUT FURTHER ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19138273 ↗
• MalfunctionDec 1, 2023Break; Break

  ON 11/03/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS-(B)(4) THAT AN AR-13250 FIBERTAPE CUTTER BROKE. THIS OCCURRED DURING A CASE. THERE WAS NO ADDITIONAL INFORMATION PROVIDED, AND ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 18248418 ↗
• MalfunctionDec 27, 2022Break

  IT WAS REPORTED ON 12/06/2022 BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-13250 FIBERTAPE CUTTER JAW SNAPPED OFF. CASE INVOLVEMENT, DEVICE BROKE DURING USE.

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

  MAUDE report 16051449 ↗
• MalfunctionJan 31, 2022Break

  ON (B)(6) 2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-13250 FIBERTAPE CUTTER THE END SNAPPED IN HALF.

  Patient problems: Insufficient Information

  MAUDE report 13395327 ↗
• MalfunctionApr 7, 2021Break

  IT WAS REPORTED THAT DURING A PROCEDURE, THE AR-13250, BREAK WHILE CUTTING TWO FIBERTAPES. NO FRAGMENTS BROKE OFF IN THE SHOULDER, AND THE CASE WAS COMPLETED BY USING A NEW AR-13250.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11630907 ↗