Arthrex® AR-8330SJRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00888867123960), received between Aug 18, 2023 and May 23, 2024 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Overheating of Device” (4 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 23, 2024Overheating of Device; Overheating of Device

  ON 04/24/2023, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA SEMS THAT AN AR-8330SJ DEVICE WAS HEATING UP DURING USE, GETTING TOO HOT. PATIENT WAS NOT AFFECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19384931 ↗
• MalfunctionApr 22, 2024Overheating of Device; Overheating of Device

  ON 03/27/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-8330SJ SHAVER HP IS OVERHEATING. NO CASE INVOLVEMENT OR PATENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19154556 ↗
• MalfunctionSep 29, 2023Overheating of Device; Overheating of Device

  ON 09/01/2023, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA (B)(4) THAT AN AR-8330SJ SHAVER IS OVERHEATING. THIS WAS DISCOVERED DURING A PROCEDURE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17843076 ↗
• MalfunctionSep 29, 2023Overheating of Device; Overheating of Device

  ON 09/01/2023, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA SEMS-06020409 THAT AN AR-8330SJ SHAVER IS OVERHEATING. THIS WAS DISCOVERED DURING A PROCEDURE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17843056 ↗
• MalfunctionAug 18, 2023Material Separation; Material Separation

  ON 07/21/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-8330SJ SHAVER WIRES ARE EXPOSED. THIS WAS DISCOVERED DURING A CASE WITH NO PATIENT EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17573184 ↗