Arthrex® AR-200SPRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888867245822), received between Oct 8, 2024 and Jan 8, 2026 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 8, 2026Detachment of Device or Device Component

  ON 16-DEC-2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT THE METAL SPRAY COMPONENT OF THE AR-200SP CAME OFF AND WOULD NOT REATTACH. NOTICED DURING A CASE, DEVICE SWAPPED, AND CASE COMPLETED WITH NO PATIENT EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24001864 ↗
• InjuryOct 8, 2024Overheating of Device; Overheating of Device

  ON 10TH SEPTEMBER 2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-200M MOTOR WITH CABLE 3.5M WAS HEATING UP. THIS WAS DETECTED DURING A TOTAL ANKLE REPLACEMENT PROCEDURE ON (B)(6) 2024. DR. (B)(6) WAS DOING A TOTAL ANKLE REPLACEMENT +/- HEEL SHIFT. ARTHREX MIS HANDPIECE WAS ON THE SETUP FOR THE +/- HEEL SHIFT PART OF THE PROCEDURE. AFTER THE CASE, THE SALES REPRESENTATIVE WAS TOLD BY THE NURSING STAFF THAT THE ARTHREX MIS HANDPIECE HAD CAUSED SEVERE BURNS TO THE PATIENT'S THIGH AREA. WHEN THE SALES REPRESENTATIVE WENT TO THE THEATRE, HE WAS TOLD BY THE SCOUT NURSE THAT THE SCOUT NURSE "ACCIDENTALLY PLUGGED THE ARTHREX MIS HANDPIECE INTO THE SYNTHES E-PEN CONSOLE BECAUSE IT FIT IN IT PERFECTLY". THAT CAUSED THE HANDPIECE TO HEAT UP AND MELT THROUGH THE HOLDING QUIVER, CAUSING THE BURNS TO THE PATIENT. SALES REPRESENTATIVE WAS TOLD BY THE SCRUB NURSE THAT NO ONE NOTICED IT HEATING UP BECAUSE THE HANDPIECE WAS NOT USED DURING THE CASE AS HEEL SHIFT WAS NOT REQUIRED AT THE END. SALES REPRESENTATIVE'S ATTENDANCE WAS NOT REQUIRED FOR THIS CASE AS BOTH NURSING STAFF ARE TRAINED AND KNOW HOW TO PLUG IN ARTHREX MIS HANDPIECE. UPDATE ON PATIENT CONDITION AS OF (B)(6) 202

  Patient problems: Full thickness (Third Degree) Burn

  MAUDE report 20396664 ↗