Arthrex® AR-8330HRecalls & reported problems

Summary

The FDA's MAUDE database contains 120 adverse event reports that list this exact device (DI 00888867043237), received between May 24, 2021 and Jul 29, 2026 — classified as 3 injuries, 117 malfunctions.

The most frequently reported specific device problem is “Overheating of Device” (27 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 120 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 29, 2026Material Deformation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50073217 ↗
• MalfunctionMar 26, 2026Device Damaged by Another Device

  ON 06-MAR-2026, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-8330H SHAVER HAND PIECE WAS DAMAGING BURS WHILE IN USE. IT WAS REPLACED WITH ANOTHER HAND PIECE AND THAT ONE WORKED PERFECTLY. THE CASE WAS COMPLETED WITHOUT ANY EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24701065 ↗
• MalfunctionFeb 26, 2026Positioning Failure

  ON 04-FEB-2026, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-8330H SHAVER IS NOT SNAPPING INTO PLACE PROPERLY. DISCOVERED DURING A CASE WITH NO PATIENT EFFECT. ADDITIONAL INFO PROVIDED 25-FEB-26: ISSUE OCCURRED IN THE SURGICAL FIELD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24453944 ↗
• MalfunctionFeb 26, 2026Positioning Failure

  ON 04-FEB-2026, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-8330H SHAVER IS NOT SNAPPING INTO PLACE PROPERLY. DISCOVERED DURING A CASE WITH NO PATIENT EFFECT. ADDITIONAL INFORMATION PROVIDED ON 25-FEB-26: ISSUE OCCURRED IN THE SURGICAL FIELD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24453776 ↗
• MalfunctionJan 5, 2026Material Frayed

  ON 15-DEC-2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-8330H SHAVER'S WIRES ARE EXPOSED. DISCOVERED AFTER THE CASE WITH NO PATIENT EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23956908 ↗
• MalfunctionDec 24, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  ON 12/04/2025, A SALES REPRESENTATIVE REPORTED VIA (B)(4) THAT AN AR-8330H SHAVER HP, APSII, HAND CONTROL HAS A CUT IN THE CORD. THIS WAS DISCOVERED AFTER USE IN A CASE WITH NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23888766 ↗
• MalfunctionNov 21, 2025Fitting Problem; Fitting Problem

  ON 10/23/2025, A SALES REPRESENTATIVE REPORTED VIA (B)(4) THAT AN AR-8330H SHAVER HANDPIECE EXPERIENCED AN ISSUE WITH THE SHAVER TIP NOT STAYING IN THE SHAVER/ NOT MATING. THIS WAS DISCOVERED DURING A CASE WITH NO PATIENT AFFECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23618244 ↗
• MalfunctionNov 7, 2025Unintended Electrical Shock; Unintended Electrical Shock

  ADDITIONAL INFORMATION WAS RECEIVED 11/24/2025 THAT THERE WAS NOT ANY EXPOSED WIRING, THE SHOCK DID NOT REQUIRE ANY MEDICAL TREATMENT, IT WAS NOT PROLONGED AND THE ENVIRONMENT WAS NOT DRY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23498986 ↗
• MalfunctionOct 30, 2025Key or Button Unresponsive/not Working; Key or Button Unresponsive/not Working

  ON 09/30/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(6) THAT AN AR-7300DS DISSECTOR HAS WEAR MARKS AT THE SHP CONNECTION. THE PHOTO PROVIDED BY THE SALES REP SHOWED DISCOLORATION ALONG THE SHAFT OF THE DISSECTOR. PER THE SALES REP, THE OTHER DEVICES BEING USED WITH THE DISSECTOR WERE AR-8330H SHAVER HANDPIECE, AN AR-8305 SYNERGY SHAVER CONSOLE, AND AN AR-8310 SHAVER FOOTSWITCH. THIS WAS DISCOVERED DURING A CASE WITH NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION WAS RECEIVED VIA MEDWATCH ON 10/10/2025: A FACILITY REPRESENTATIVE REPORTED THAT AN AR-8305 SYNERGY RESECTION SHAVER CONSOLE WAS USED DURING A PROCEDURE ON (B)(6) 2025. AFTER THE SURGEON REMOVED THE ARTHROSCOPIC SHAVER FROM THE PATIENT AND WAS ABOUT TO PLACE IT ON THE MAYO STAND, THE SURGICAL TEAM OBSERVED THAT THE DEVICE REMAINED ACTIVE DESPITE THE SWITCH BEING TURNED OFF. ADDITIONAL INFORMATION WAS RECEIVED VIA PHONE ON 10/15/2025: PER THE REP, THE EVENT OCCURRED OUTSIDE THE PATIENT, ON THE MAYO STAND, AFTER THE AR-7300DS HAD BEEN USED AND WAS NO LONGER REQUIRED FOR THE PROCEDURE. IT IS UNKNOWN HOW LONG THE AR-7300DS WAS USED CONTINUOUSLY, AND WHETHER ANY WEAR MARKS WERE PRESENT AT THE PROXIMAL END WHERE IT CO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23429803 ↗
• MalfunctionJul 18, 2025Break; Break

  ON 06/03/2025, IT WAS REPORTED BY A FACILITIES REPRESENTATIVE VIA SEMS-06914671 THAT AN AR-8500OBE FLUTE SET HAD EXPERIENCED BREAKS DURING A CASE WITHIN AN AR-8330H SHAVER HANDPIECE. THIS WAS DISCOVERED DURING A CASE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22545580 ↗
• MalfunctionJul 14, 2025Unintended Movement; Unintended Movement

  ON 06/17/2025, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA (B)(4) THAT AN AR-8330H SHAVER WAS WOBBLY. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22493803 ↗
• MalfunctionMay 13, 2025Material Frayed; Use of Device Problem; Material Frayed; Use of Device Problem

  ON 04/22/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(6) THAT AN AR-3210-0025 CAMERA'S CORD IS FRAYED. DISCOVERED DURING A CASE WITH NO PATIENT EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22012221 ↗
• MalfunctionApr 21, 2025Material Frayed; Material Frayed

  ON 04/01/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(6) THAT AN AR-8330H SHAVER'S CORD IS FRAYED. DISCOVERED DURING THE CASE, DEVICE SWAPPED, AND CASE COMPLETED WITH NO PATIENT EFFECT. ADDITIONAL INFORMATION RECEIVED 4/15/25. IT WAS REPORTED ON (B)(6) 2025 THAT THE CORD WAS BULGING THROUGHOUT THE CABLE AND STICKING OUT THROUGH THE SHEATH. CABLE IS NOT SMOOTH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21871783 ↗
• MalfunctionMar 27, 2025Break; Device Damaged by Another Device; Break; Device Damaged by Another Device

  ON 03/07/2025, A SALES REPRESENTATIVE REPORTED VIA (B)(4) THAT AN AR-8330H SHAVER HP HAD A PIECE OF A BROKEN TIP OF AN AR-8400TD TORPEDO THAT COULD HAVE BROKEN OFF AND FALLEN INSIDE. THE ISSUE WAS DISCOVERED DURING THE SURGERY. ANOTHER DEVICE WAS SWAPPED, AND THE CASE WAS COMPLETED WITHOUT ADVERSE EFFECTS ON THE PATIENT. X-RAYS WERE TAKEN, AND THERE WERE NO PIECES OF THE BROKEN DEVICE INSIDE THE PATIENT. THIS WAS DISCOVERED DURING A PROCEDURE, WITH NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21708118 ↗
• MalfunctionJan 20, 2025Material Frayed; Material Frayed

  ON (B)(6) 2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-8330H SHAVER HANDPIECE HAS A FRAYED WIRE ON THE END OF THE CAP. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21190681 ↗
• MalfunctionDec 13, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  ON (B)(6)2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-8330H SHAVER'S BUTTON FUNCTION ARE REVERSED, AND THE CORD IS CUT EXPOSING THE WIRES. DISCOVERED DURING A CASE, DEVICE SWAPPED, AND CASE COMPLETED WITH NO PATIENT EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20926306 ↗
• MalfunctionSep 25, 2024Material Frayed; Material Frayed

  ON (B)(6) 2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(6) THAT AN AR-8330H SHAVER HANDPIECE WIRES WERE EXPOSED. THERE WAS NO CASE INVOLVEMENT THAT IS KNOWN.

  Patient problems: Insufficient Information

  MAUDE report 20301902 ↗
• MalfunctionSep 19, 2024Loose or Intermittent Connection; Loose or Intermittent Connection

  ON 09/09/2024, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA (B)(4) THAT AN AR-8330H SHAVER HAS ATTACHMENTS THAT WOBBLE AT THE BLADE TIP ON ANY MODE. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20258789 ↗
• MalfunctionSep 4, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  ON 08/09/2024, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA (B)(4) THAT AN AR-8330H SHAVER HANDPIECE HAD A RIP IN THE CORD. THIS WAS DISCOVERED DURING THE CASE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20135477 ↗
• MalfunctionAug 8, 2024Defective Device; Defective Device

  ON 07/17/2024 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-8330H SHAVER HANDPIECE DISPLAYED AN ERROR CODE WHEN IT WAS BEING USED AND ALSO OVERHEATED WHILE IN USE. THIS WAS DISCOVERED DURING THE CASE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19939434 ↗
• MalfunctionJul 25, 2024Overheating of Device; Overheating of Device

  ON 06/24/2024, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA SEMS-(B)(4) THAT AN AR-8330H SHAVER IS OVERHEATING. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19833874 ↗
• MalfunctionJun 20, 2024Overheating of Device; Overheating of Device

  ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-8330H SHAVER HANDPIECE HAD AN ISSUE. THE MOTOR SOUNDED LIKE IT WENT UP, AND THE HANDPIECE WAS EXTREMELY HOT. THEY SWAPPED IT OUT AND FINISHED THE CASE. THIS OCCURRED DURING USE WITH NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED. ON (B)(6) 2023, THE SALES REPRESENTATIVE PROVIDED THE FOLLOWING INFORMATION VIA EMAIL: THIS EVENT OCCURRED DURING A SHOULDER SCOPE PROCEDURE ON (B)(6) 2023. NOTHING HAPPENED WHEN THE HANDLE GOT HOT. THEY HANDED IT OFF TO THE NURSE, WHO HANDED IT TO THE SALES REPRESENTATIVE. NO HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19578583 ↗
• MalfunctionJun 20, 2024Overheating of Device; Overheating of Device

  ON 04/17/2023, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA SEMS THAT AN AR-8330H HAND CONTROL IS GETTING VERY HOT. THIS OCCURRED DURING A CASE, WITH NO PATIENT EFFECT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19574987 ↗
• MalfunctionJun 17, 2024Overheating of Device; Overheating of Device

  IT WAS REPORTED ON (B)(6) 2022 BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-8330H SHAVER IS BURNING UP DUE TO THE BLADES. CASE INVOLVEMENT, NO PATIENT EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19549131 ↗
• MalfunctionJun 10, 2024Excessive Heating; Excessive Heating

  ON 12/23/2022, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA SEMS THAT AN AR-8330H SHAVER HANDPIECE GOT TOO HOT WHEN IN USE. NO CASE INVOLVEMENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED. ON 2/8/2023, THE FACILITY REPRESENTATIVE STATED THE FOLLOWING INFORMATION VIA EMAIL: THEY DID REACH OUT TO THE USERS OF THE ITEM BUT DID NOT GET ANY FURTHER INFORMATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED. ON 2/10/2023, THE FACILITY REPRESENTATIVE CONFIRMED VIA PHONE THAT NO STAFF OR PATIENT AT THE FACILITY WAS HARMED OR INJURED DURING THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19498028 ↗