Arthrex® AR-18700-35Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00888867312807), received between Oct 27, 2023 and Jan 17, 2024 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 17, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  ON 12/20/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS-(B)(4) THAT THE DEPTH DEVICES, AR-18700-27 AND AR-18700-35. ARE NOT READING ACCURATELY AND NOT SLIDING. OCCURRED DURING A CASE WITH NO ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18528393 ↗
• MalfunctionNov 15, 2023Physical Resistance/Sticking; Physical Resistance/Sticking

  ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS (B)(4) THAT AN AR-18700-27 DEPTH DEVICE AND AN AR-18700-35 DEPTH DEVICE WERE DEFECTIVE; BOTH DEVICES WOULD STICK WHEN ATTEMPTING TO READ DEPTH AND MAKING IT DIFFICULT FOR THE SURGEON TO GET AN ACCURATE READING. THE CASE WAS COMPLETED UTILIZING THE DEPTH GAUGE FROM THE 2.4/3.0 CFS SET. THIS HAS OCCURRED IN PREVIOUS CASES. THIS WAS DISCOVERED DURING AN METACARPAL FRACTURE PROCEDURE ON 10/18/2023, WITH NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18140585 ↗
• MalfunctionOct 27, 2023Incorrect Measurement; Inadequacy of Device Shape and/or Size; Incorrect Measurement; Inadequacy of Device Shape and/or Size

  ON 10/2/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-18724-08 LOW PROFILE SCREW, AR-18724-12 LOW PROFILE SCREW, AND AN AR-18724-18 LOW PROFILE SCREW ALL HAD THE SAME ISSUE DUE TO THE AR-18700-35 DEPTH GAUGE DEVICE. DURING AN ORIF FOR AN ACROMIAL FRACTURE ON (B)(6) 2023, THE THREE LOW-PROFILE SCREWS WERE REMOVED DUE TO BEING TOO LONG WHEN AN X-RAY WAS PERFORMED WHILE THE PATIENT WAS UNDER ANESTHESIA. THE SCREWS WERE MEASURING LONGER THAN THE BONE ANATOMY DUE TO THE DEPTH GAUGE DEVICE BEING INCORRECTLY ASSEMBLED BY STERILIZATION. THE CASE WAS COMPLETED USING SHORTER REPLACEMENT SCREWS FROM THE SAME SET WITH A THREE-MINUTE DELAY IN THE PROCEDURE, AND NO ADDITIONAL ANESTHESIA WAS ADMINISTERED. THE ENTIRE PROCEDURE TOOK 90 MINUTES, AND NO FRAGMENTS BROKE. THIS WAS DISCOVERED DURING AN ORIF FOR AN ACROMIAL FRACTURE PROCEDURE ON (B)(6) 2023.

  Patient problems: Insufficient Information

  MAUDE report 18022606 ↗