Arthrex® AR-8330FRecalls & reported problems

Summary

The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 00888867043220), received between Dec 20, 2019 and May 11, 2026 — classified as 1 injury, 27 malfunctions.

The most frequently reported specific device problem is “Overheating of Device” (8 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 28 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 11, 2026Device Emits Odor

  IT WAS REPORTED THAT THERE WAS A BURNING SMELL. THIS WAS NOTICED BEFORE THE SURGERY. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. NO FURTHER INFORMATION RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25135519 ↗
• MalfunctionJun 18, 2024Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT THE DEVICE GETS HOT. NO ADDITIONAL INFORMATION REGARDING A SPECIFIC FAILURE MODE WAS PROVIDED. NO FURTHER INFORMATION RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19563879 ↗
• MalfunctionJun 7, 2024Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT DURING SURGERY/ TREATMENT THE DECIVE BECAME HOT AND THEN SHUT DOWN. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH THE SAME DEVICE USED ANYWAY. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY. NO FURTHER INFORMATION RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19492302 ↗
• MalfunctionJun 7, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE CABLE IS CUT. THERE WAS NO HARM FOR THE PATIENT, OPERATOR OR THIRD PARTY REPORTED. ALSO THERE WAS NO CASE INVOLVEMENT REPORTED. NO FURTHER INFORMATION RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19485894 ↗
• MalfunctionMay 23, 2024Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC SURGERY THE DEVICE GOT HOT. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A DIFFERENT DEVICE. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19387616 ↗
• MalfunctionMay 22, 2024Defective Device; Defective Device

  IT WAS REPORTED THAT THE DEVICE IS NOISY AND SMELLS SMOKY. THERE WAS NO HARM OR ADVERSE EVENT FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. NO FURTHER INFORMATION RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19374080 ↗
• MalfunctionMay 15, 2024Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT DURING A SURGERY THE HAND PIECE WAS DEFECTIVE AND GOT HOT. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19319277 ↗
• MalfunctionMay 13, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE DEVICE STICKS AND GETS HOT. NO ADDITIONAL INFORMATION REGARDING A SPECIFIC FAILURE MODE WAS PROVIDED. NO FURTHER INFORMATION RECEIVED.

  Patient problems: Insufficient Information

  MAUDE report 19299177 ↗
• MalfunctionMay 13, 2024Excessive Heating; Excessive Heating

  IT WAS REPORTED THAT THE DEVICE STICKS AND GETS HOT. NO ADDITIONAL INFORMATION REGARDING A SPECIFIC FAILURE MODE WAS PROVIDED. NO FURTHER INFORMATION RECEIVED.

  Patient problems: Insufficient Information

  MAUDE report 19299130 ↗
• MalfunctionMay 13, 2024Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT THE DEVICE HAS SPEED FLUCTUATIONS DURING USE AND GETS HOT. THERE WAS NO HARM OR ADVERSE EVENT FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. NO FURTHER INFORMATION RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19297231 ↗
• MalfunctionMay 13, 2024Overheating of Device; Overheating of Device

  THIS IS A CONVERSION FROM (B)(6) LINE NUMBER: 293942. AN CUSTOMER UPDATE WAS RECEIVED WHICH MADE A REPAIR TO A COMPLAINT. THE CUSTOMER STATED THE DEVICE BECOMES HOT AND DOES NOT WORK PROPERLY. THERE WAS NO HARM OR ADVERSE EVENT FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED BY THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19296818 ↗
• MalfunctionMay 7, 2024Defective Device; Defective Device

  ON 03/25/2022, IT WAS REPORTED BY A DISTRIBUTOR VIA (B)(4) THAT A AR-8330F SHAVER WILL NOT OSCILLATE, AND IS OVERHEATING. THIS OCCURRED ON (B)(6) 2022 DURING AN UNKNOWN CASE, WITH NO PATIENT EFFECT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19262504 ↗
• MalfunctionMay 7, 2024Intermittent Loss of Power; Intermittent Loss of Power

  IT WAS REPORTED THAT THERE WERE SPEED FLUCTUATIONS. THE HANDPIECE BECOMES HOT. THERE WAS NO HARM OR ADVERSE EVENT FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. NO FURTHER INFORMATION RECEIVED. UPDATE DU 24-MAR-2022: THE PROBLEM OCCURRED DURING SURGERY. THE CONTROL UNIT AND THE SHAVER WERE REPLACED BY THE SURGICAL STAFF AND THE SURGERY CONTINUED. NO PERSON WAS HARMED. NEITHER THE PATIENT NOR THE OPERATOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19262164 ↗
• MalfunctionDec 15, 2023Leak/Splash; Leak/Splash

  ON 11/15/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS-06402354 THAT AN AR-8330F SHAVER IS LEAKING. THIS WAS DISCOVERED BEFORE USE IN A CASE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18340649 ↗
• MalfunctionNov 29, 2023Overheating of Device; Overheating of Device

  ON 11/13/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS-06399930 THAT AN AR-8330F SHAVER IS OVERHEATING. THIS WAS DISCOVERED DURING USE IN A CASE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18229321 ↗
• MalfunctionNov 6, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE CABLE HAS A CUT. THERE WAS NO HARM FOR THE PATIENT, OPERATOR OR THIRD PARTY REPORTED. NO FURTHER INFORMATION RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18075056 ↗
• MalfunctionOct 20, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE DEVICE HAS CUTS IN THE CABLE. THERE WAS NO HARM FOR THE PATIENT, OPERATOR OR THIRD PARTY REPORTED. NO FURTHER INFORMATION RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17974834 ↗
• MalfunctionAug 22, 2023Overheating of Device; Overheating of Device

  ON (B)(6) 2023, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA SEMS THAT AN AR-8330F SHAVER IS OVERHEATING. THIS WAS DISCOVERED DURING AN UNSPECIFIED TIME WITH NO PATIENT EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17597364 ↗
• MalfunctionAug 2, 2023Defective Device; Defective Device

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY THE DEVICE SHOWS ERROR MESSAGES S222 AND S52 ERROR HAND PIECE. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17444507 ↗
• MalfunctionDec 7, 2021Break

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY SURGERY THE DEVICE HAD A MOTOR DAMAGE. NO PART OF THE DEVICE BROKE OFF. ACCORDING TO THE SURGEON NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY OCCURRED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A DIFFERENT DEVICE. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12953244 ↗
• MalfunctionDec 7, 2021Break

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY SURGERY THE DEVICE HAD A MOTOR DAMAGE. NO PART OF THE DEVICE BROKE OFF. ACCORDING TO THE SURGEON NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY OCCURRED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A DIFFERENT DEVICE. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12953227 ↗
• MalfunctionMar 15, 2021Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE FOLLOWING DEVICES WERE PRESENT DURING A PROCEDURE: AR-3350-2430, AR-3350-4030, AR-3210-0001, AR-8330F, WHEREAS A PATIENT GOT AN INFECTION. IT WAS FOUND THAT THE INFECTION IS NOT DUE TO ARTHREX PRODUCT(S), HOWEVER, CUSTOMER WOULD LIKE TO CHANGE ALL THEIR PRODUCTS THAT WERE USED DURING THIS PROCEDURE.

  Patient problems: Unspecified Infection

  MAUDE report 11485728 ↗
• MalfunctionMar 15, 2021Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE FOLLOWING DEVICES WERE PRESENT DURING A PROCEDURE,AR-3350-2430, AR-3350-4030, AR-3210-0001, AR-8330F, WHEREAS A PATIENT GOT AN INFECTION. IT WAS FOUND THAT THE INFECTION IS NOT DUE TO ARTHREX PRODUCT(S), HOWEVER, CUSTOMER WOULD LIKE TO CHANGE ALL THEIR PRODUCTS THAT WERE USED DURING THIS PROCEDURE.

  Patient problems: Unspecified Infection

  MAUDE report 11485644 ↗
• MalfunctionFeb 1, 2021Computer Software Problem

  IT WAS REPORTED, THAT THE SYNERGY RESECTION SHAVER CONSOLE (AR-8305, SN (B)(4)) SHOWS THE ERROR MESSAGE H15 WHEN THE SHAVER HANDPIECE (AR-8330F, SN (B)(4)) IS PLUGGED IN. THE CUSTOMER REQUESTS AN INSPECTION OF ALL DEVICES INCLUDING THE FOOTSWITCH (AR-8310, SN (B)(4)). THERE WAS NO HARM OR ADVERSE EVENT FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. THE SURGERY WASN`T COMPLETED, BECAUSE NO BACKUP DEVICE WAS AVAILABLE. ACCORDING TO THE CUSTOMER, SEVERAL HANDPIECES ARE ALREADY DEFECTIVE. A SECOND SURGERY IS NECESSARY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11258887 ↗
• MalfunctionDec 7, 2020Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SHAVER WAS USED DURING SURGERY WHEN PATIENT GOT CARDIAC ARRHYTHMIA. SURGEON STOPPED THE SHAVER. WHEN THE SURGEON USED THE SHAVER AGAIN, THE CARDIAC ARRHYTHMIA OCCURRED AGAIN WITH THE PATIENT. AFTER SECOND USE THE SURGEON WAS FINISHED WITH USAGE OF THE SHAVER AND THEREFORE HE DIDN´T NEED TO CHANGE THE SHAVER. THE PATIENT IS WELL. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: Arrhythmia

  MAUDE report 10962305 ↗