Arthrex® AR-9811Recalls & reported problems

Summary

The FDA's MAUDE database contains 168 adverse event reports that list this exact device (DI 00888867248243), received between Jan 20, 2017 and Sep 16, 2026 — classified as 29 injuries, 139 malfunctions.

The most frequently reported specific device problem is “Break” (60 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 168 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 16, 2026Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50787873 ↗
• MalfunctionMar 19, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING THE KNEE ARTHROSCOPY, A METAL PART DETACHED FROM THE DEVICE AFTER IT HAD BEEN IN USE FOR TWO MINUTES. THE DETACHED PIECE WAS RETRIEVED FROM THE PATIENT. 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 24637594 ↗
• MalfunctionJan 2, 2026Material Separation

  ON 15TH DECEMBER 2025, IT WAS REPORTED BY A DISTRIBUTOR VIA EMAIL THAT FOR AN AR-9811, APOLLORF MP90, ASPIRATING ABLATOR, 90°, MULTI-PORT, THE APOLLO PROBE METAL SURFACE SEPARATED. THIS WAS DETECTED DURING USE IN AN ARTHROSCOPIC RCT REPAIR PROCEDURE ON (B)(6) 2025. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AS A NEW PROBE WAS USED. ALL FRAGMENTS WERE REMOVED FROM THE PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 23946297 ↗
• MalfunctionOct 23, 2025Component Missing; Device Damaged by Another Device; Electrical Shorting; Component Missing; Device Damaged by Another Device; Electrical Shorting

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY THE APOLLO WAS ACTIVATED AND AN ELECTRIC ARC WAS CREATED DUE TO A LACK OF INSULATION. THIS RESULTED IN TWO DEFECTIVE OPTICS (DIFFERENT MANUFACTURER). THE OPTICS AND THE APOLLO DEVICE DID NOT TOUCH EACH OTHER. THE SECOND APOLLO THEN WORKED. THERE WAS NO ERROR MESSAGE ON THE APOLLO CONSOLE PRIOR TO THE FAILURE. 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. ***UPDATE AVOE 20-OCT-2025 IT WAS CONFIRMED THAT PART OF THE INSULATION CAME LOOSE DURING THE OPERATION. NO PART OF THE DEVICE REMAINED INSIDE THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23366790 ↗
• MalfunctionSep 16, 2025Break; Break

  ON 08/26/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-9811 ABLATION PROBE'S FACE STARTED TO DISINTEGRATE, LEAVING A HOLE IN THE CENTER BETWEEN THE PORTS. NOTICED DURING THE PROCEDURE WITH NO PATIENT EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23064763 ↗
• MalfunctionAug 8, 2025Material Discolored; Material Discolored

  ON 22ND JULY 2025, IT WAS REPORTED BY AN ARTHREX'S EMPLOYEE VIA EMAIL THAT FOR AN AR-9811, APOLLORF MP90, ASPIRATING ABLATOR, 90°, MULTI-PORT, THE TIP TURNED BLACK AND DID NOT WORK WELL DURING THE OPERATION. THERE WAS A DELAY IN THE SURGERY OF ABOUT 5 MINUTES IN CHANGING TO THE NEW TIP. THIS WAS DETECTED DURING A SHOULDER RCR ON (B)(6) 2025. THE CASE WAS COMPLETED SUCCESSFULLY BY USING A REPLACEMENT PRODUCT. THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION WAS RECEIVED ON 25TH JULY 2025: THE CAUSE OF THE TIP DISCOLORATION WAS NOT CONFIRMED. THERE WAS NO BURNING SMELL WHEN THE ISSUE OCCURRED, NOR WERE ANY OTHER ISSUES NOTICED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22749848 ↗
• MalfunctionAug 1, 2025Detachment of Device or Device Component; Device Dislodged or Dislocated; Detachment of Device or Device Component; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A ROTATOR CUFF SURGERY THE APOLLO FELL APART AT THE END OF THE OPERATION. PARTS CAME LOOSE. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH THE SAME DEVICE. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY. ***UPDATE AVOE 15-JUL-2025 IT WAS FURTHER CONFIRMED BY THE SURGEON THAT THE TIP AT THE FRONT HAS BECOME COMPLETELY DETACHED, I.E. HAS FALLEN OFF COMPLETELY.

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

  MAUDE report 22687803 ↗
• MalfunctionJul 18, 2025Overheating of Device; Noise, Audible; Overheating of Device; Noise, Audible

  IT WAS REPORTED THAT THE DEVICE IS DEFECTIVE. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THERE WAS NO CASE INVOLVEMENT. NO FURTHER INFORMATION RECEIVED. UPDATE 20-JUN-2025: THE REPORTED DEVICE WAS RETURNED TO ARTHREX GMBH WITH AN ADDITIONAL FAILURE DESCRIPTION. THE REPORTED DEVICE MADE A "POPPING" NOISE AND THE DEVICE STOPPED WORKING DURING USE. IT WAS FURTHER REPORTED THAT THE TIP OF THE DEVICE OVERHEATED. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22546302 ↗
• MalfunctionJun 23, 2025Defective Device; Device Damaged by Another Device; Defective Device; Device Damaged by Another Device

  IT WAS REPORTED DURING THE SHOULDER-ARTHROSCOPY WITH SUTURE OF THE ROTATOR-CUFF THAT THE FIBERWIRE AND THE FIBERTAPE ARE CUT BY THE DEVICE AT THE SLIGHTEST TOUCH. THIS MEANS THAT CUTTING THROUGH A SOFT TISSUE BRIDGE LEADS TO CUTTING THROUGH THE FIBERTAPE. 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 22308115 ↗
• MalfunctionApr 17, 2025Arcing; Arcing

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY ROTATOR CUFF REPAIR SURGERY WHEN INTRODUCING THE APOLLO PROBES AR-9811 (LOT: 76114820 AND 79061158) A WHITE FLASH LIGHT SUDDENLY APPEARED ACTIVATING THE RF FROM THE HANDPIECE. THIS OCCURRED NOT AT THE VERY BEGINNING BUT AFTER A FEW SECONDS OPERATING IN THE SUBACROMIAL SPACE. FOOTSWITCH CONTROL WAS NOT CONNECTED. THAT FLASH DESTROYED THE OPTIC ON THE TIP. SURGEONS NOTICED THAT THE ENERGY FROM THE PROBES LOOKED ¿MORE POWERFUL THAN USUAL¿ AT THE BEGINNING OF THE PROCEDURE. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITHOUT THE DEVICES AND BY TISSUE ABLATION THROUGH SHAVING ONLY. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21858656 ↗
• MalfunctionApr 17, 2025Arcing; Arcing

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY ROTATOR CUFF REPAIR SURGERY WHEN INTRODUCING THE APOLLO PROBES AR-9811 (LOT: 76114820 AND 79061158) A WHITE FLASH LIGHT SUDDENLY APPEARED ACTIVATING THE RF FROM THE HANDPIECE. THIS OCCURRED NOT AT THE VERY BEGINNING BUT AFTER A FEW SECONDO OPERATING IN THE SUBACROMIAL SPACE. FOOTSWITCH CONTROL WAS NOT CONNECTED. THAT FLASH DESTROYED THE OPTIC ON THE TIP. SURGEONS NOTICED THAT THE ENERGY FROM THE PROBES LOOKED ¿ MORE POWERFUL THAN USUAL¿ AT THE BEGINNING OF THE PROCEDURE. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITHOUT THE DEVICES AND BY TISSUE ABLATION THROUGH SHAVING ONLY. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21856850 ↗
• MalfunctionApr 17, 2025Overheating of Device; Overheating of Device

  ON 3/18/2025, IT WAS REPORTED BY A COMPETENT AUTHORITY VIA EMAIL THAT DURING A ROTATOR CUFF REPAIR (RCR) PROCEDURE, AN AR-9811 APOLLORF MP90 ASPIRATING ABLATOR WAS BEING USED FOR ARTHROSCOPIC CAUTERY. THE IRRIGATION SOLUTION USED DURING THE PROCEDURE WAS LACTATED RINGER¿S WITH ADDED EPINEPHRINE 1:100,000. PER THE REPORT, WHEN USING THE AR-9811 FOR CAUTERY, THE IRRIGATION SOLUTION IN THE SHOULDER BECOMES EXTREMELY HOT AND CAUSES BURNS TO THE PATIENT WHEN THE IRRIGATION SOLUTION COMES OUT OF THE SHOULDER. THIS OCCURRED THREE TIMES PROCEDURE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Burn(s)

  MAUDE report 21854884 ↗
• MalfunctionFeb 19, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING A ROTATOR CUFF SURGERY THE CASING OF THE DEVICE WAS 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 21412905 ↗
• MalfunctionFeb 5, 2025Sparking; Sparking

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPY SURGERY, THERE WAS A SPARKING ON THE PROBE HEAD DURING THE ABLATION PROCEDURE AND AFTER THIS THE OPTIC WAS DEFECTIVE ACCORDING TO INITIAL IMPRESSION. IT IS UNCLEAR WHETHER THE LENS IS ONLY ¿FOGGED UP¿ AND CAN BE RESTORED WITH POLISHING PASTE OR NOT. 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 21314174 ↗
• MalfunctionOct 31, 2024Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT DURING A SHOULDER ROTATOR CUFF SURGERY THE APOLLO DEVICE BURNED THROUGH. 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 20579347 ↗
• MalfunctionOct 9, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING A ROTATOR CUFF SURGERY THE TIP OF THE DEVICE BURNT, TURNED BLACK, AND DISINTEGRATED IN EXTREME SMALL PIECES. THE BROKEN PIECES WAS NOT RETRIEVED OUT OF THE PATIENT. THE SURGERY HOWEVER WAS FINISHED SUCCESSFULLY. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY. UPDATE DW 30-SEP-2024: FURTHER INFORMATION WAS PROVIDED THAT THE TIP OF THE DEVICE BURNT, TURNED BLACK, AND DISINTEGRATED IN EXTREME SMALL PIECES.THE HANDPIECE WAS DISCARDED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AS THE DEVICE WAS NOT NECESSARY ANYMORE WHEN THE ISSUE OCCURRED.

  Patient problems: Foreign Body In Patient

  MAUDE report 20408052 ↗
• MalfunctionSep 12, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A SHOULDER AND ROTATOR CUFF ARTHROSCOPY A PART OF THE APOLLO DEVICE WAS IDENTIFIED FLOATING IN THE JOINT. THE FRAGMENT COULD BE RETRIEVED FROM THE PATIENT. THIS INCIDENT OCCURED AT THE END OF THE SURGERY, THEREFORE NO FURTHER APOLLO DEVICE WAS OPENED. ACCORDING TO THE SURGEON NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY OCCURRED. THE SURGERY WAS FINISHED SUCCESSFULLY. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20205965 ↗
• MalfunctionJul 5, 2024Break; Material Fragmentation; Break; Material Fragmentation

  ON 6/11/2024, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA SEMS-(B)(4) THAT AN AR-9811 APOLLORF MP90 TIP OF THE ELECTRODE WAS CHIPPED DURING USE. THE CASE WAS COMPLETED WITH ANOTHER AR-9811 APOLLORF MP90. THIS WAS DISCOVERED DURING USE ON (B)(6) 2024, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION WAS RECEIVED ON 6/13/2024: THIS WAS DISCOVERED DURING A ARCR PROCEDURE ON (B)(6) 2024.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19681226 ↗
• MalfunctionJun 18, 2024Material Frayed; Material Frayed

  IT WAS REPORTED THAT THAT DURING A PROCEDURE, THE END OF THE OUTER SHEATH, AR-9811, LOT: 2011020, BEGAN FRAYING/PEELING. THE CASE WAS COMPLETED BY USING A NEW AR-9811.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19560987 ↗
• MalfunctionJun 13, 2024Break; Break

  ON 02/22/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT A AR-9811 APOLLORFS TIP CAME LOOSE. THIS OCCURRED DURING A CASE, ALL PIECES WERE REMOVED. A NEW DEVICE WAS OPENED AND USED TO COMPLETE THE CASE. ADDITIONAL INFORMATION PROVIDED ON 02/27/2023, IT WAS REPORTED THAT THIS EVENT OCCURRED DURING A SHOULDER SUB ACROMIAL DECOMPRESSION ON (B)(6) 2023. THE TIP DID NOT FALL OFF INTO THE PATIENT. THE CASE WAS COMPLETED USING ANOTHER AR-9811.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19527995 ↗
• MalfunctionJun 13, 2024Break; Break

  ON 1/9/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-9811 PORTED METAL DISC ON TIP BECAME LOOSE. THIS WAS DISCOVERED DURING A PROCEDURE WITH NO HARM TO THE PATIENT. THE PIECE DID NOT DETACH FROM THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19527144 ↗
• MalfunctionJun 12, 2024Material Twisted/Bent; Material Twisted/Bent

  ON 12/30/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT A AR-9811 APOLLORFS HOOD WAS DAMAGED. THIS OCCURRED DURING A CASE, WITH NO PATIENT EFFECT REPORTED. NO ADDITIONAL INFORMATION PROVIDED. ADDITIONAL INFORMATION REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19519463 ↗
• MalfunctionJun 7, 2024Break; Break

  ON 12/22/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-9811 APOLLORF MP90 ELECTRODE BEGAN TO LOOSEN/SEPARATE FROM WAND BUT DID NOT BREAK OR DETACH FROM THE DEVICE. THIS WAS DISCOVERED DURING A SUBACROMIAL DECOMPRESSION ON (B)(6) 2022. THE CASE WAS COMPLETED BY USING A NEW AR-9811. THERE WAS NO PATIENT EFFECT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19484969 ↗
• MalfunctionJun 5, 2024Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT DURING AN ROTATOR CUFF SUTURE SURGERY THE HEAD OF THE DEVICE SCORCHED. 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 19469982 ↗
• MalfunctionJun 4, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON 11/21/2022 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT A AR-9811 APOLLORF WAS USED TO DEBRIDE SHOULDER PRIOR TO COMPLETING AC JOINT RECONSTRUCTION WHEN ELECTRODE BEGAN TO LOOSEN. THIS OCCURRED DURING A AC JOINT RECONSTRUCTION ON (B)(6) 2022, AN XL90 WAND WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT EFFECT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19458028 ↗