Arthrex® AR-8305Recalls & reported problems

Summary

The FDA's MAUDE database contains 78 adverse event reports that list this exact device (DI 00888867123854), received between Feb 11, 2021 and Jul 27, 2026 — classified as 2 injuries, 76 malfunctions.

The most frequently reported specific device problem is “Smoking” (20 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 25 most recent of 78 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 27, 2026Overheating of Device; Smoking

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50011567 ↗
• MalfunctionOct 30, 2025Key or Button Unresponsive/not Working; Key or Button Unresponsive/not Working

  ON (B)(6) 2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) 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 C

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23430167 ↗
• MalfunctionAug 7, 2025Moisture Damage; Use of Device Problem; Moisture Damage; Use of Device Problem

  ON (B)(6) 2025, A FACILITY REPRESENTATIVE REPORTED VIA (B)(4) THAT AN AR-8305 SYNERGY RESECTION SHAVER CONSOLE GOT WET IN A CASE, AND IT DOESN'T WORK. NO PATIENT WAS HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22742978 ↗
• MalfunctionMay 22, 2025Smoking; Electrical Shorting; Smoking; Electrical Shorting

  IT WAS REPORTED THAT WHEN STARTING THE CONSOLE SOME SORT OF SHORT CIRCUIT HAPPENED AND SMOKE CAME OUT. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THIS WAS NOTICED BEFORE THE SURGERY. THERE WAS NO CASE INVOLVEMENT. NO FURTHER INFORMATION RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22072591 ↗
• MalfunctionFeb 13, 2025Intermittent Loss of Power; Intermittent Loss of Power

  ON 01/24/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-8305 SHAVER CONSOLE IS "ACTING UP". IT WILL INTERMITTENTLY CUT IN AND OUT. THERE WAS POSSIBLE SPILL DAMAGE TO THE MACHINE. THERE WAS ALSO A SMALL DELAY TO THE CASE. THE PROCEDURE THAT SHOULD'VE TAKEN 20 MINUTES TOOK 30. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21374970 ↗
• MalfunctionJan 7, 2025Fluid/Blood Leak; Fluid/Blood Leak

  ON 12/10/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-8305 SYNERGY RESECTION SHAVER CONSOLE HAD FLUID LEAK DOWN INTO THE BOX. THE TUBING WAS PUNCTURED DURING THE CASE WHICH LED TO FLUID RUNNING DOWN ONTO/INTO A SHAVER BOX THAT SAT RIGHT BELOW THE PUMP. THIS SHAVER BOX IS NOW MALFUNCTIONING. THIS WAS DISCOVERED DURING THE CASE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21090818 ↗
• MalfunctionNov 8, 2024Device Emits Odor; Device Emits Odor

  IT WAS REPORTED THAT THE DEVICE SMELLS BURNT AND ELECTRICAL NOISES CAN BE HEARD. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20639447 ↗
• MalfunctionNov 1, 2024Overheating of Device; Overheating of Device

  ON 10/17/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS-06688800 THAT AN AR-8305 SYNERGY RESECTION CONSOLE STOPPED DURING THE CASE AND SMELLED LIKE BURNING PLASTIC. THIS WAS DISCOVERED DURING THE CASE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20586473 ↗
• MalfunctionAug 14, 2024Smoking; Smoking

  ON 07/31/2024 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-8305 SYNERGY RESECTION SHAVER CONSOLE HAD AN ELECTRICAL SHORT AND DISPLAYED CRITICAL ERROR WHILE SMOKE CAME FROM THE MACHINE. THIS WAS DISCOVERED DURING THE CASE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19987755 ↗
• MalfunctionJul 11, 2024Moisture Damage; Moisture Damage

  ON 6/20/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-8305 SYNERGY RESECTION SHAVER CONSOLE HAD WATER INSIDE. THE DEVICE WAS SWITCHED OUT. THIS WAS DISCOVERED DURING A PROCEDURE, WITH NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19719146 ↗
• MalfunctionJul 1, 2024Loss of Power; Loss of Power

  ON 06/12/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-8305 SHAVER CONSOLE IS CAUSING AN ISSUE. THIS IS ONE OF FIVE DEVICES THAT ARE LINKED TOGETHER. WHEN PLUGGED IN, ONE OR MORE OF THESE DEVICES CAUSE A LOSS OF POWER FOR ALL INSTRUMENTS USING THAT SAME OUTLET (THEY ARE PLUGGED INTO A MEDICAL GRADE OUTLET ON THE WALL IN THE OR, NOT JUST A POWER STRIP). THE CONTACT IS UNABLE TO FIGURE OUT WHICH CAUSES THE ISSUE; THEREFORE, THEY'D LIKE TO REPLACE THEM ALL. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19644055 ↗
• MalfunctionJun 19, 2024Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT THE AR-8305 CONSOLE IS ACTING WEIRD AND HAD AN ELECTRICAL BURNING SMELL.

  Patient problems: Insufficient Information

  MAUDE report 19566052 ↗
• MalfunctionJun 4, 2024Electrical Shorting; Electrical Shorting

  ON 11/07/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-8305 SHAVER POSSIBLY SHORTED AFTER SALINE FELL ON IT, THROWING LOTS OF ERRORS. THIS WAS DISCOVERED DURING USE IN AN UNSPECIFIED CASE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19460514 ↗
• MalfunctionMay 24, 2024Display or Visual Feedback Problem; Display or Visual Feedback Problem

  ON 4/26/2024, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA (B)(4) THAT AN AR-8305 SYNERGY RESECTION SHAVER CONSOLE HAD A BAD DISPLAY. THE FACILITY REPRESENTATIVE WHO REPORTED THE COMPLAINT WAS UNSURE IF THIS OCCURRED DURING A CASE AND IF THE PATIENT WAS AFFECTED.ADDITIONAL INFORMATION HAS BEEN REQUESTED

  Patient problems: Insufficient Information

  MAUDE report 19394171 ↗
• MalfunctionMay 20, 2024Moisture Damage; Moisture Damage

  ON 12/17/2021, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-8305 SYNERGY RESECTION SHAVER CONSOLE HAD WATER DAMAGE TO THE CONSOLE. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS WAS DISCOVERED DURING USE WITH NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19351082 ↗
• MalfunctionMay 16, 2024Device Alarm System; Device Alarm System

  SHAVER CONSOLE H15 FAULT-FLUID HAS GOTTEN INTO THE FRONT OF THE CONSOLE, THE CONSOLE IS NOW SHOWING A H15 ERROR.

  Patient problems: Insufficient Information

  MAUDE report 19333441 ↗
• MalfunctionMay 13, 2024Overheating of Device; Overheating of Device

  IT WAS REPORTED ON 07/11/2022 BY A FACILITY REPRESENTATIVE VIA SEMS THAT AN AR-8305 SHAVER CONSOLE SMELLS LIKE ITS BURNING, AND IS NOT RESPONDING. THIS WAS DISCOVERED DURING A CASE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19298108 ↗
• MalfunctionMay 10, 2024Defective Device; Defective Device

  ON 02/22/2022 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-8305 SHAVER CONSOLE DISPLAYED ERROR MESSAGE H15, REP STATES THERE IS WATER INSIDE THE CONSOLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19287622 ↗
• MalfunctionApr 29, 2024Moisture Damage; Moisture Damage

  ON (B)(6)2024, IT WAS REPORTED BY A DISTRIBUTOR VIA SEMS-06532027 THAT AN AR-8305 SYNERGY CONSOLE GOT WATER INTO ONE OF THE ACCESSORY PORTS ON THE FRONT OF THE SHAVER CONSOLE, AND THAT PORT IS NO LONGER WORKING. THIS WAS DISCOVERED DURING AN UNSPECIFIED PROCEDURE, WITH NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19202988 ↗
• MalfunctionApr 23, 2024Smoking; Smoking

  ON 28TH MARCH 2024, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT AN AR-8305, (SYNERGY RESECTION SHAVER CONSOLE) HAD SMOKE COMING FROM THE CONSOLE. THIS WAS DETECTED AT AN UNSPECIFIED TIME ON (B)(6) 2024 WITH NO CASE INVOLVEMENT.

  Patient problems: Insufficient Information

  MAUDE report 19163687 ↗
• MalfunctionApr 22, 2024Loss of Power; Loss of Power

  IT WAS REPORTED THAT DURING A TISSUE RESECTION SURGERY THE DEVICE STOPPED WORKING. 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 19151505 ↗
• MalfunctionApr 19, 2024Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED THE CONSOLE IS PRODUCING A CRITICAL ERROR MESSAGE WHEN IT IS POWERED ON. IN ADDITION IT IS CREATING A BURNING SMELL. THIS OCCURRED DURING SET UP AND IT WAS PULLED FROM THE ROOM AND WAS NOT USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19142415 ↗
• MalfunctionMar 12, 2024Overheating of Device; Overheating of Device

  ON (B)(6) 2024, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT FOR AN AR-8305, (SYNERGY RESECTION SHAVER CONSOLE) WAS RETURNED FROM THE QLD OFFICE. IT WAS UNKNOWN IF THE UNIT WAS WORKING. THE UNIT WAS NOT ON SYSTEM BASE. SERVICE TESTED THE UNIT AND FOUND THE DISPLAY WAS NOT WORKING AND A BURNING SMELL WAS COMING FROM THE UNIT. THIS WAS DETECTED AT AN UNSPECIFIED TIME ON (B)(6) 2023 WITH NO CASE INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18888734 ↗
• MalfunctionMar 7, 2024Device Emits Odor; Device Emits Odor

  IT WAS REPORTED THAT DURING SHOULDER SURGERY A "POPPING" SOUND WAS HEARD, A BURNING SMELL WAS NOTICED AND THE DEVICE SHUT OFF. IT WAS FURTHER REPORTED THAT THE EVENT OCCURRED AFTER 9 MINUTES. THE DEVICE ITSELF WAS UNPACKED AND CONNECTED PRIOR TO THIS SURGERY. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. 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 18856453 ↗
• MalfunctionFeb 9, 2024Device Emits Odor; Device Emits Odor

  ON 01/24/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-8305 SHAVER CONSOLE IS CAUSING A BURNING SMELL. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18676546 ↗