Arthrex® AR-8500OBERecalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 00888867043862), received between Sep 19, 2018 and Apr 8, 2026 — classified as 5 injuries, 22 malfunctions.

The most frequently reported specific device problem is “Break” (14 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 27 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 8, 2026Material Fragmentation

  IT WAS REPORTED THAT DURING AN ANKLE ARTHROSCOPY METAL DEPOSITS DETACHED FROM THE SHAVER BLADE AND REMAINED IN THE PATIENT. VISIBLE DEPOSITS WERE REMOVED FROM THE PATIENT. 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: Foreign Body In Patient

  MAUDE report 24816273 ↗
• MalfunctionMar 19, 2026Break

  IT WAS REPORTED THAT DURING THE HIP ARTHROSCOPY, THE DEVICES BROKE AND COULD NO LONGER ROTATE. NO FRAGMENTS REMAINED IN 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 24643462 ↗
• MalfunctionMar 19, 2026Break

  IT WAS REPORTED THAT DURING THE HIP ARTHROSCOPY, THE DEVICE BROKE AND COULD NO LONGER ROTATE. NO FRAGMENTS REMAINED IN 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 24643445 ↗
• MalfunctionMar 19, 2026Break

  IT WAS REPORTED THAT DURING THE HIP ARTHROSCOPY, THE DEVICE BROKE AND COULD NO LONGER ROTATE. NO FRAGMENTS REMAINED IN 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 24643443 ↗
• MalfunctionJul 18, 2025Break; Break

  ON 06/03/2025, IT WAS REPORTED BY A FACILITIES REPRESENTATIVE VIA (B)(4) THAT AN AR-8500OBE FLUTE SET HAD EXPERIENCED BREAKS WHEN INSERTING PARTS INTO THE SHAVER HANDPIECE. THIS WAS DISCOVERED DURING A CASE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22541282 ↗
• MalfunctionJun 23, 2025Break; Break

  ON 06/03/2025, IT WAS REPORTED BY A FACILITIES REPRESENTATIVE VIA (B)(4) THAT AN AR-8500OBE FLUTE SET HAD EXPERIENCED BREAKS WHEN INSERTING PARTS INTO THE SHAVER HANDPIECE. THIS WAS DISCOVERED DURING A CASE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22308341 ↗
• MalfunctionMay 19, 2025Break; Break

  IT WAS REPORTED THAT DURING A SHOULDER DECOMPRESSION AND CUFF REPAIR SURGERY THE BURR SLEEVES AR-8500OBE (LOT: 15351155) BROKE. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. 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 22044972 ↗
• MalfunctionMay 19, 2025Break; Break

  IT WAS REPORTED THAT DURING A SHOULDER DECOMPRESSION AND CUFF REPAIR SURGERY THE BURR SLEEVES AR-8500OBE (LOT: 15351155) BROKE. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. 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 22044932 ↗
• MalfunctionDec 6, 2024Material Fragmentation; Material Fragmentation

  ON (B)(6) 2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS-06717638 THAT AN AR-8500OBE BURR PRODUCED DEBRIS. "DURING THE USE OF THE BONE SHAVER BLADE, SEVERAL STEEL FILAMENTS CAME LOOSE INSIDE THE JOINT. IT WAS NOT POSSIBLE TO REMOVE ALL THE FILAMENTS FROM INSIDE THE JOINT. ACCORDING TO THE DOCTOR, THERE WAS NO IMPACT ON THE PATIENT AND THE FRAGMENTS WILL ONLY BE SEEN DURING IMAGING TESTS. THE PACKAGE WAS INTACT WITH NO DAMAGE. THERE WAS NO INCREASE IN SURGICAL TIME." THIS WAS DISCOVERED DURING USE IN A CASE WITH NO PATIENT HARM.

  Patient problems: Foreign Body In Patient

  MAUDE report 20869019 ↗
• MalfunctionOct 22, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC KNEE SURGERY THE CONNECTION (PLASTIC) ON THE SHAVER ATTACHMENT BROKE AND CRUMBLED. THE DEVICE DID NOT BREAK INSIDE 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 20509261 ↗
• MalfunctionOct 22, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC KNEE SURGERY THE CONNECTION (PLASTIC) ON THE SHAVER ATTACHMENT BROKE AND CRUMBLED. THE DEVICE DID NOT BREAK INSIDE 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 20508640 ↗
• MalfunctionJun 5, 2024Break; Break

  ON 12/27/2022 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT (QTY.2) AR-8500OBE BURR ENGAGEMENT PADDLES BROKE OFF INSIDE THE DEVICE AND (QTY.3) AR-9811 RF APOLLO INSTRUMENTS ARE NOT RESPONDING WHEN PLUGGED IN. THIS WAS DISCOVERED DURING A PROCEDURE WITH NO PATIENT HARM. ADDITIONAL INFORMATION REQUESTED 2/10/23.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19472126 ↗
• MalfunctionMay 23, 2024Excessive Heating; Excessive Heating

  ON 12/20/2021, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-8500OBE BURR GOT HOT INSTANTLY AFTER ABOUT 15 SECONDS OF BEING IN USE. THIS WAS DISCOVERED DURING A SHOULDER ARTHROSCOPY/ ROTATOR CUFF REPAIR ON (B)(6) 2021. SURGEON COMPLETED CASE WITHOUT FURTHER ISSUES USING A NEW BURR.

  Patient problems: Insufficient Information

  MAUDE report 19381479 ↗
• MalfunctionDec 26, 2023Break; Break

  ON 11/29/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(6) THAT (2) AR-8500OBE OVAL BURRS BROKE. THIS OCCURRED DURING A DISTAL CLAVICAL EXCISION. NO ADDITIONAL INFORMATION WAS PROVIDED, AND ADDITIONAL INFORMATION HAS BEEN ASKED.

  Patient problems: Insufficient Information

  MAUDE report 18394215 ↗
• MalfunctionDec 26, 2023Break; Break

  ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS-06412642 THAT (2) AR-8500OBE OVAL BURRS BROKE. THIS OCCURRED DURING A DISTAL CLAVICAL EXCISION. NO ADDITIONAL INFORMATION WAS PROVIDED, AND ADDITIONAL INFORMATION HAS BEEN ASKED.

  Patient problems: Insufficient Information

  MAUDE report 18394214 ↗
• MalfunctionDec 1, 2023Defective Device; Defective Device

  ON 10/11/02/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS (B)(4) THAT (2) AR-8500OBE OVAL BURRS STRIPPED OUT AT THE JUNCTION POINT BETWEEN THE HUB OF THE BURR AND THE SHAVER HANDPIECE. THIS OCCURRED DURING A ROTATOR CUFF REPAIR ON (B)(6) 2023 WHERE THE SURGEON WASN'T APPLYING A LOT OF PRESSURE OR TORQUE, THE CASE WAS COMPLETED USING A THIRD AR-8500OBE. THERE WAS NO EFFECT ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18251471 ↗
• MalfunctionNov 29, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ON ''10/11/02/2023'', IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT (2) AR-8500OBE OVAL BURRS STRIPPED OUT AT THE JUNCTION POINT BETWEEN THE HUB OF THE BURR AND THE SHAVER HANDPIECE. THIS OCCURRED DURING A ROTATOR CUFF REPAIR ON (B)(6) 2023WHERE THE SURGEON WASN'T APPLYING A LOT OF PRESSURE OR TORQUE. THE CASE WAS COMPLETED USING A THIRD AR-8500OBE. THERE WAS NO EFFECT ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18226805 ↗
• MalfunctionNov 20, 2023Unstable; Unstable

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY THE BURR STARTED TO WOBBLE DURING USE AND THE OUTER SLEEVE DISLODGED FROM THE CONNECTION. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY AND THE SAME DEVICE WAS USED ANYWAY. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18174655 ↗
• MalfunctionNov 6, 2023Defective Device; Defective Device

  IT WAS REPORTED THAT DURING A RM SUTURE SURGERY THE DEVICE DOES NOT RUN SMOOTHLY WHEN IT WAS USED THE FIRST TIME. 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 18076161 ↗
• MalfunctionSep 18, 2023Defective Device; Defective Device

  IT WAS REPORTED THAT THE SHAVER ATTACHMENT IS DEFECTIVE. IT DOES NOT RUN SMOOTHLY AND IT COULD NOT BE USED ANYMORE. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. NO FURTHER INFORMATION RECEIVED. ***UPDATE 29-AUG-2023 NROE: FURTHER INFORMATION REVEALED THAT THIS INCIDENT OCCURRED DURING AN ARTHROSCOPY. 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 17767781 ↗
• MalfunctionMay 23, 2022Break

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY WHILE THE SURGEON USED THE SHAVER THE BURR STOPPED AND IT WAS FOUND THAT THE SHAFT WAS BROKEN. THE BROKEN PART WAS RETRIEVED OUT OF THE PATIENT. ACCORDING TO THE SURGEON 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 14468855 ↗
• MalfunctionApr 4, 2022Break

  ON (B)(6) 2022, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA SEMS THAT AN AR-8500OBE ATTACHMENT THAT CONNECTS THE BURR TO THE HANDLE THAT ALLOWS FOR DEVICE ROTATION BREAKING DURING USE AND NOT ALLOWING FOR PROPER FUNCTION. THIS WAS DISCOVERED DURING USE IN A PROCEDURE.

  Patient problems: Insufficient Information

  MAUDE report 13995312 ↗
• InjuryMar 21, 2022Adverse Event Without Identified Device or Use Problem; Excessive Heating; Excessive Heating

  ON (B)(6)2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-8500OBE BURR BURN THE PATIENT SUPERFICIALLY WHEN IT WAS CONNECTED TO AN AR-8330H SHAVER HANDPIECE. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6)2022.

  Patient problems: Burn(s); Superficial (First Degree) Burn

  MAUDE report 13839537 ↗
• InjuryNov 22, 2021Smoking; Excessive Heating; Excessive Heating

  ON (B)(6) 2021 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(6) THAT DURING A SHOULDER DECOMPRESSION PROCEDURE AN AR-8330H STARTED TO DECREASE SPEED AND THEN CREATED SMOKE WHILE BURNING THE PATIENTS SKIN. THE SHAVER AND BURR WERE REPLACED TO COMPLETE THE CASE.

  Patient problems: Burn(s); Insufficient Information

  MAUDE report 12853673 ↗
• InjuryDec 28, 2020Material Fragmentation

  IT WAS REPORTED THAT METAL SHAVINGS WERE SEEN COMING OFF THE AR-8500OBE BURR DURING AN ACROMIOPLASTY. THE REP REPORTED THAT THE PROCEDURE WAS COMPLETED WITHOUT ISSUE. ADDITIONAL INFORMATION RECEIVED ON 12/8/2020: THE REP REPORTED THEY ASSUME THE SURGEON USED SUCTION ON THE SHAVER WITHOUT RUNNING IT TO ATTEMPT TO REMOVE THE METAL SHAVINGS, BUT IT CANNOT BE CONFIRMED IF ALL SHAVINGS WERE REMOVED FROM THE PATIENT. THE SURGEON SUCKED OUT AS MANY AS THEY COULD AS BEST THEY COULD.

  Patient problems: Foreign Body In Patient

  MAUDE report 11075956 ↗