Arthrex® AR-18800-05Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00888867385658), received between Apr 11, 2024 and Feb 4, 2025 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 4, 2025Material Twisted/Bent; Material Twisted/Bent

  ON 01/14/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-18800-04 DRIVER SHAFT AND AN AR-18800-05 SOLID SCREWDRIVER WERE TORQUED. THIS WAS DISCOVERED DURING THE CASE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21306725 ↗
• MalfunctionOct 17, 2024Break; Break

  ON 09/26/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-18800-05 SOLID SCREWDRIVER TIP BROKE OFF INSIDE OF THE SCREW HEAD INSIDE THE PATIENT. THE CASE WAS NOT AFFECTED. THIS WAS DISCOVERED DURING A PROCEDURE ON 09/19/2024, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20472611 ↗
• MalfunctionMay 17, 2024Material Twisted/Bent; Material Twisted/Bent

  ON 04/22/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT DURING A PROCEDURE MULTIPLE DEVICES FAILED. DURING THE PROCEDURE AN AR-18800-04 DRIVER SHAFT BECAME TWISTED, AN AR-18800-04 DRIVER SHAFT SNAPPED OFF, (2) AR-18800-03 DRIVER SHAFTS WERE TWISTED, AN AR-18700-39 TORQUE LIMITING ADAPTER WAS NOT CLICKING WHEN THE TORQUE WAS REACHED, A AR-18800-05 SOLID SCREWDRIVER WAS TWISTED, AND A AR-18700-45 POINTED REDUCTION FORCEPS WOULD NOT CLOSE. NO ADDITIONAL INFORMATION WAS PROVIDED, AND ADDITIONAL INFORMATION HAS BEEN ASKED.

  Patient problems: Insufficient Information

  MAUDE report 19343543 ↗
• MalfunctionApr 11, 2024Material Twisted/Bent; Material Twisted/Bent

  ON 3/20/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT (2) AR-18800-03 DRIVER SHAFT AND AN AR-18800-05 SOLID SCREWDRIVER WERE TWISTED DURING SURGERY. THIS WAS DISCOVERED DURING A PROCEDURE, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2024: THIS WAS DISCOVERED DURING AN ORIF PROCEDURE ON (B)(6) 2024. THE CASE WAS COMPLETED USING THE TWISTED DRIVERS. THERE WAS NO REPORTED DELAY IN THE CASE OR ADVERSE EFFECTS ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19091191 ↗