Arthrex® AR-9815Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 00888867142527), received between Jul 16, 2018 and Feb 12, 2025 — classified as 1 injury, 21 malfunctions.

The most frequently reported specific device problem is “Break” (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. 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 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 12, 2025Defective Device; Material Split, Cut or Torn; Defective Device; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING A KNEE ARTHROSCOPY THE TIP OF THE DEVICE GOT DAMAGED. PER COMPLAINT REPORTER 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 21364946 ↗
• MalfunctionJan 23, 2025Break; Break

  ON (B)(6) 2024 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-9815 APOLLO RF BROKE AND THERE WAS DEBRIS INSIDE THE PATIENT. THIS WAS DISCOVERED DURING THE CASE WITH NO PATIENT HARM.

  Patient problems: Foreign Body In Patient

  MAUDE report 21220483 ↗
• MalfunctionJan 13, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  ON (B)(6)2024, AN FDA MEDWATCH NOTIFICATION WAS RECEIVED VIA EMAIL. A FACILITY REPRESENTATIVE REPORTED THAT AN AR-9815 APOLLORF MP50 ASPIRATING ABLATOR WAS USED WITH THE POWER SOURCE, AND IT ACTED AS IF IT WAS FUNCTIONING BUT THERE WAS NOT VISIBLE ABLATION OF TISSUE. WHEN THE BUTTON WAS DEPRESSED, NOTHING HAPPENED. UPON FURTHER INSPECTION THE PORT WHERE THE DISPOSABLE DEVICE ATTACHES WERE FOUND TO BE BURNED. THIS WAS DISCOVERED DURING A PROCEDURE IN (B)(6) 2024. NO FURTHER INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION RECEIVED ON 12/31/2024: THE FACILITY REPRESENTATIVE DOES NOT HAVE SUFFICIENT INFORMATION TO PROVIDE A PART AND LOT NUMBER FOR THE POWER SOURCE USED WITH THE AR-9815 APOLLORF MP50 ASPIRATING ABLATOR. THE PROCEDURE OCCURRED ON (B)(6)024. NOTHING BROKE INSIDE THE PATIENT, AND THE CASE WAS COMPLETED AS PLANNED WITHOUT THE USE OF THE ABLATOR. THE CASE WAS DELAYED ABOUT TEN MINUTES WITHOUT ADDITIONAL ANESTHESIA.

  Patient problems: Insufficient Information

  MAUDE report 21138385 ↗
• MalfunctionJan 8, 2025Break; Break

  ON (B)(6) 2024, A SALES REPRESENTATIVE REPORTED VIA (B)(4) THAT AN AR-9815 APOLLORF MP50, ASPIRATING ABLATOR, HAD AN UNEXPECTED EVENT, WITH NO FURTHER INFORMATION PROVIDED. THE REP STATED THAT THE SURGEON DISCOVERED THE METAL AND HAD PICTURES OF THE SURGERY. THE CASE WAS DELAYED 15 MINUTES TO RETRIEVE METAL FRAGMENTS FROM THE PATIENT. IT WAS REPORTED THAT THE PATIENT WAS NOT HARMED. THIS WAS DISCOVERED DURING A PROCEDURE. ADDITIONAL INFORMATION WAS RECEIVED ON 12/30/2024: THE DEVICE BROKE IN THE PATIENT WHILE IN USE AND LEFT BEHIND METAL AND PLASTIC PIECES. ALL FRAGMENTS WERE RETRIEVED FROM THE PATIENT. THE DEVICE PRODUCED DEBRIS AND ALL DEBRIS WAS REMOVED FROM THE PATIENT. THERE WERE NO ERROR MESSAGES PRIOR TO OR DURING THE EVENT. THE DEVICE SETTINGS WERE 7/2. THE ABLATOR DID NOT COME IN CONTACT WITH ANY OTHER DEVICES DURING USE. THE ABLATOR WAS IN CONSTANT USE FOR 45 SECONDS. THE CASE WAS COMPLETED WITH THE WAND. ON THE FINAL X-RAYS THEY SAW DEBRIS (SEE PHOTOS). THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THE ISSUE. THIS WAS DISCOVERED DURING A HIP ARTHROSCOPY WITH LABRAL REPAIR PROCEDURE ON (B)(6)2024.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21102563 ↗
• MalfunctionOct 10, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ANKLE ARTHROSCOPY THE TIP OF THE DEVICE BROKE OFF. THE BROKEN OFF TIP WAS SEARCHED BUT COULD NOT BE FOUND. AN X-RAY PICTURE WAS TAKEN BUT THE MISSING TIP COULD NOT BE FOUND INSIDE THE PATIENT. THE SURGERY WAS FINISHED SUCCESSFULLY. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: Insufficient Information

  MAUDE report 20417481 ↗
• MalfunctionAug 8, 2024Break; Break

  UPDATE SWIT 22-AUG-2024: WHEN SURGEON START ACTIVATING THE RF IT DID NOT SHOW ANY SIGNS OF WORKING. THEY DISCONNECTED AND RESTARTED THE RF CONSOLE BUT STILL NOTHING WERE WORKING UNTIL THEY PLUGGED IN ANOTHER RF ITEM THEN EVERYTHING WAS PERFECTLY RUNNING. NO PIECES BROKE OFF INSIDE THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19937633 ↗
• MalfunctionJun 24, 2024Overheating of Device; Overheating of Device

  ON 05/28/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-9815 APOLLORF MP50 WANDS METAL END BURNED OFF. THIS OCCURRED DURING A KNEE SCOPE ON (B)(6) 2024 WHEN THE METAL END OF THE APOLLORF MP50 WAND BURNED OFF WHILE ABLATING TISSUE INSIDE THE JOINT. ALL FRAGMENTS WERE RETRIEVED USING A GRASPER. THERE WAS A SHORT DELAY IN REPLACING THE WAND. THE CASE WAS COMPLETED USING ANOTHER DEVICE.

  Patient problems: Insufficient Information

  MAUDE report 19592933 ↗
• MalfunctionJun 14, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED ON 10/24/2022 BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-9815 APOLLO PROBE RING FELL OFF. THIS WAS DISCOVERED DURING A CASE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19543281 ↗
• MalfunctionJun 13, 2024Material Separation; Material Separation

  ON 05/08/2023, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA SEMS THAT AN AR-9821 APOLLORF, AND (2) AR-9815 APOLLORF WHEN PLUGGED INTO THE MACHINE BEGIN TO COME APART. THIS OCCURRED DURING A CASE, WITH NO PATIENT EFFECT REPORTED. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19531211 ↗
• MalfunctionApr 23, 2024Crack; Crack

  IT WAS REPORTED THAT THE CERAMIC PART NEAR THE TIP OF AR-9815 HAS CRACKED. NO ADVERSE EFFECT ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19165417 ↗
• MalfunctionJan 24, 2024Overheating of Device; Overheating of Device

  ON 01/05/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT DURING A PROCEDURE, THE TIP OF THE MP50 APOLLO, AR-9815, STARTED BURNING. THE APOLLO WAS REPLACED AND THE CASE WAS COMPLETED. ADDITIONAL INFORMATION REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 18576042 ↗
• MalfunctionFeb 27, 2023Break; Detachment of Device or Device Component; Break

  ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-9815 APOLLORF MP50 ASPIRATING ABLATOR PLASTIC END CAME PART FROM THE PROBE. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2023.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16444622 ↗
• MalfunctionJan 9, 2023Detachment of Device or Device Component

  IT WAS REPORTED ON (B)(6) 2022 BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-9815 APOLLO PROBE FELL APART DURING A CASE, THE GREY RING SURROUNDING THE BURNER FELL OFF. THIS WAS DISCOVERED DURING A CASE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16120634 ↗
• MalfunctionDec 5, 2022Break

  IT WAS REPORTED THAT DURING A HIP ARTHROSCOPY THE TIP OF THE DEVICE BROKE OFF WHEN THE PROBE WAS RETRACTED. THE BROKEN OFF PART WAS RETRIEVED FROM THE PATIENT. THE SURGICAL TECHNIQUE HAD TO BE SWITCHED TO AN OPEN PROCEDURE. THE SURGERY WAS FINISHED SUCCESSFULLY AND THE DEVICE WAS NOT NEEDED ANYMORE. IT WAS NOT NECESSARY TO DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15914182 ↗
• MalfunctionNov 7, 2022Detachment of Device or Device Component

  ON (B)(6)2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT A AR-9815 APOLLO RF'S PLASTIC SHEET FROM THE HAND ALL THE WAY TO THE TIP HAS BEEN BURNING OFF AND COMING OFF. THIS OCCURRED DURING AN UNKNOWN CASE, WITH NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15742750 ↗
• InjurySep 26, 2022Break; Detachment of Device or Device Component

  ON (B)(6) 2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-9815 APOLLORF¿ MP50, ASPIRATING ABLATOR, 50°, MULTI-PORT HAD AN ISSUE, THE DISTAL TIP BROKE AND FELL OF RF. THIS WAS DISCOVERED DURING USE WITH NO IMPACT TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED. ON 09/09/2022, THE SALES REPRESENTATIVE REPLIED VIA EMAIL AND STATED THE FOLLOWING INFORMATION: THIS EVENT OCCURRED DURING AN ACL REVISION PROCEDURE ON (B)(6) 2022. THE DEVICE WAS INSERTED INTO THE JOINT, THEY STARTED ABLATION OF A COUPLE OF INTERVALS OF A FEW SECONDS EACH WITH PAUSES IN BETWEEN UNTIL NOTICING THE WHITE RING HAD FALLEN OFF. THE INSTRUMENT BROKE INSIDE THE PATIENT AND ALL FRAGMENTS WERE REMOVED. THE DEVICE WAS DISCARDED BY THE FACILITY. THERE WERE NO ALARM MESSAGES, AND THE ABLATOR DID NOT COME IN CONTACT WITH ANY OTHER DEVICES DURING USE. THE CASE WAS COMPLETED AS SCHEDULED. THE PATIENT IS FINE TO DATE. ON 9/23/2022, THE SALES REPRESENTATIVE CALLED AND STATED THE FOLLOWING INFORMATION VIA PHONE: AN X-RAY OF THE PATIENT WAS TAKEN AFTER THE ORIGINAL SURGERY, AND THE SURGEON DEEMED A REVISION SURGERY NECESSARY TO REMOVE THE HARDWARE FROM THE PATIENT. THE REVISION SURGERY TOOK PLACE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15484205 ↗
• MalfunctionAug 29, 2022Sparking

  ON 08/08/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-9800 SYNERGYRF¿ CONSOLE AND AN AR-9815 APOLLO RF 50° HAD AN ISSUE. THE HANDPIECE PROBE TIP WAS SPARKING INSIDE THE PATIENT. THIS WAS DISCOVERED DURING USE WITH NO IMPACT TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED. ON 08/24/2022, THE SALES REPRESENTATIVE REPLIED VIA EMAIL AND STATED THE FOLLOWING: THE ISSUE WAS APPARENTLY WITH THE RF APOLLO TIP AND NOT THE UNIT. THAT WAS WORKING FINE. THEY JUST CHANGED THE APOLLO RF PROBE, AND THE SURGERY (UNSPECIFIED PROCEDURE) CONTINUED WITHOUT INCIDENT. THE SURGEON MENTIONED THAT THERE WAS NO HARM RELATED TO IT, AND THE SURGERY WAS FINISHED WITH ANOTHER RF APOLLO PROBE AND THE SAME CONSOLE UNIT. THE PROBE WAS AVAILABLE FOR RETURN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15310911 ↗
• MalfunctionJul 25, 2022Power Problem

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY IT WAS NOTICED THAT THE PLASMA FIELD IS DESCRIBED AS "FIRE", THERE WAS NO ABLATION POWER AND A TOTAL FAILURE. THE PROBE WAS EXCHANGED AND THE SURGERY WAS COMPLETED SUCCESSFULLY. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY. UPDATE 15-JUL-2022: DURING ABLATION THERE WAS A CLEAR VISUAL FIRE-LIKE FLASH ON THE SCREEN AND THEN THE PROBE DID NOT WORK ANYMORE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15093826 ↗
• MalfunctionFeb 28, 2022Break; Overheating of Device; Material Puncture/Hole

  IT WAS REPORTED THAT DURING AN ANKLE JOINT ARTHROSCOPY THE DEVICE WAS USED FOR SOFT TISSUE ABLATION. AFTER APPROX. 1.5 HOURS SURGERY DURATION AND FREQUENT USE OF THE HF ATTACHMENT, THE SURGEON COMPLAINED THAT THE DEVICE WAS GETTING VERY HOT. SHORTLY THEREAFTER, THERE WAS AN EXPLOSION-LIKE NOISE AND THE HANDPIECE HAD A HOLE. 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 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 13620235 ↗
• MalfunctionNov 22, 2021Therapeutic or Diagnostic Output Failure

  IT WAS REPORTED THAT DURING A KNEE ARTHROSCOPY THE DEVICE STOPPED WORKING. NO PART OF THE DEVICE BROKE OFF. THERE WAS NO HARM OR ADVERSE EVENT 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. DURING RETURNED DEVICE EVALUATION, A REPORTABLE MALFUNCTION WAS DISCOVERED.

  Patient problems: Insufficient Information

  MAUDE report 12853664 ↗
• MalfunctionNov 8, 2021Unexpected Shutdown

  IT WAS REPORTED ON 09/16/2021 BY A FACILITY REPRESENTATIVE VIA SEMS THAT AN AR-9815 APOLLO STOPPED WORKING IN THE MIDDLE OF A CASE. THIS WAS DISCOVERED DURING A CASE WITH NO PATIENT HARM. DURING RETURNED DEVICE EVALUATION, A REPORTABLE MALFUNCTION WAS DISCOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12770487 ↗
• MalfunctionJul 16, 2018Detachment of Device or Device Component

  THE ARTHREX REF AR-9815 APOLLORF MP50 ASPIRATING ABLATOR 50 MULTI-PORT WAS USED IN KNEE ARTHROSCOPY AND A PIECE OF THE INSULATION CAME OFF IN THE PATIENT'S KNEE. THIS WAS REMOVED DURING CASE AND THERE WAS NO PATIENT HARM. THE BROKEN INSTRUMENT WAS SWITCHED OUT TO A NEW ONE.

  Patient problems: Foreign Body In Patient

  MAUDE report 7689581 ↗