Arthrex® AR-8315WRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00888867315778), received between Nov 9, 2023 and Nov 27, 2024 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Component Missing” (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. 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.

• MalfunctionNov 27, 2024Device Emits Odor; Device Emits Odor

  ON (B)(6) 2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-8315W SYNERGY RESECTION WIRELESS FS KIT SMELLS LIKE THERE IS SMOKE COMING FROM IT. IT IS ALSO NOT CONNECTING TO THE BLUETOOTH/WIRELESS. NO CASE/PATIENT INVOLVEMENT.

  Patient problems: Insufficient Information

  MAUDE report 20797220 ↗
• MalfunctionJun 17, 2024Overheating of Device; Defective Device; Overheating of Device; Defective Device

  ON 5/20/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-8315W SYNERGY RESECTION WIRELESS FOOTSWITCH KIT WHEN PLUGGED WITH THE BLUETOOTH TO THE DEVICE IT WOULD STATE "GAS PEDAL STUCK". THE BLUETOOTH PLUG RED LIGHT WAS FLASHING VERY FAST AND WHEN THEY TRIED TO SWITCH OUT THE BATTERIES IT WAS EXTREMELY HOT. THERE WAS NO CASE INVOLVEMENT, AND NO PATIENT WAS AFFECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19546594 ↗
• MalfunctionJan 17, 2024Component Missing; Component Missing

  ON 12/21/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS-06437508 THAT AN AR-8315W SYNERGY RESECTION WIRELESS KIT WAS MISSING A BLACK PAD ON THE BOTTOM AND CASING IS LOOSE. THIS WAS DISCOVERED AFTER THE CASE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18526557 ↗
• MalfunctionNov 9, 2023Key or Button Unresponsive/not Working; Key or Button Unresponsive/not Working

  ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-8315W FOOTSWITCH IS NOT RESPONDING. THIS WAS DISCOVERED DURING USE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18103792 ↗