Arthrex® AR-8500BLRecalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00888867043749), received between May 3, 2018 and Oct 30, 2024 — classified as 3 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Break” (7 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 30, 2024Material Fragmentation; Material Fragmentation

  ON (B)(6) 2024, A SALES REPRESENTATIVE REPORTED VIA (B)(4) THAT AN AR-8500BL BLURR WAS LEAVING METAL SHAVINGS. THIS WAS DISCOVERED DURING A PROCEDURE, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20569730 ↗
• MalfunctionOct 30, 2024Material Fragmentation; Material Fragmentation

  ON (B)(6) 2024, A SALES REPRESENTATIVE REPORTED VIA (B)(4) THAT AN AR-8500BL BLURR WAS LEAVING METAL SHAVINGS IN THE SHOULDER DURING SUBACROMIAL DECOMPRESSION. THE SPEED WAS SET TO 8000 FORWARDS. METAL SHAVINGS WERE THEN REMOVED USING AN AR-8400DC SHAVER. NO HARM TO THE PATIENT WAS REPORTED, AND THE CASE WAS FINISHED IN THE USUAL MANNER. THIS WAS DISCOVERED DURING A SHOULDER ARTHROSCOPY ON (B)(6) 2024, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20569596 ↗
• MalfunctionJun 10, 2024Break; Break

  ON 03/08/2023, IT WAS REPORTED BY A DISTRIBUTOR VIA SEMS THAT AN AR-8500BL BLURR BENT. THIS OCCURRED DURING A CASE, AFTER RESECTING IN THE ANKLE IT WAS REMOVED AND FOUND TO BE BENT. THERE WAS NO PATIENT EFFECT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19497381 ↗
• MalfunctionMar 14, 2024Break; Break

  IT WAS REPORTED THAT DURING AN SAD SURGERY THE END OF THE DEVICE BROKE OFF INSIDE THE PATIENT. THE BROKEN PIECE WAS RETRIEVED. 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 18906252 ↗
• MalfunctionMar 14, 2024Break; Break

  IT WAS REPORTED THAT DURING AN SAD SURGERY THE END OF THE DEVICE BROKE OFF INSIDE THE PATIENT. THE BROKEN PIECE WAS RETRIEVED. 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 18906227 ↗
• MalfunctionMar 14, 2024Break; Break

  IT WAS REPORTED THAT DURING AN SAD SURGERY THE END OF THE DEVICE BROKE OFF INSIDE THE PATIENT. THE BROKEN PIECE WAS RETRIEVED. 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 18906202 ↗
• MalfunctionFeb 6, 2023Break; Mechanics Altered

  ON 1/17/2023 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-8500OBE OVAL BURR WASN'T SPINNING, AND A AR-8500BL BLURR HAD BROKEN IN HALF. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2022.

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

  MAUDE report 16302951 ↗
• MalfunctionFeb 9, 2021Break

  IT WAS REPORTED, THAT DURING A SHOULDER ARTHROSCOPIC PROCEDURE, WHEN THE SURGEON WAS BURRING THE ACCROMIUM, THE BURR AR-8500BL, INNER BLADE SNAPPED IN HALF, AT THE BASE OF THE SHAVER. THE BROKEN FRAGMENT WAS ISOLATED TO THE SHAVER AND THE CASE WAS COMPLETE BY USING ANOTHER AR-8500BL WITHOUT FURTHER ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11302264 ↗
• InjuryDec 16, 2019Break; Material Fragmentation; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR THE TIP BROKE OFF. ALL WAS RETRIEVED. IT WAS REPLACED AND THE CASE WAS CONTINUED. THE REPLACEMENT WAS USED BUT IT PRODUCED METAL SHAVINGS. THE DOCTOR RETRIEVED THE SHAVINGS AS BEST HE COULD BUT SOME OF THE SHAVINGS WERE NOT. THE SHAVER BLADE WAS REPLACED A THIRD TIME. WAITING FOR ADDITIONAL INFORMATION. ADDITIONAL INFORMATION OBTAINED 12/02/2019: A TOTAL OF TWO AR-8500BL (BLURR, 5.0 MM X 13 CM) WERE USED DURING THE ROTATOR CUFF PROCEDURE. LOT 10345209 WAS USED AND THE DEVICE BROKE OFF AT THE BASE. THE ITEM WAS IN USE AT THE TIME. THE PROCEDURE WAS IMMEDIATELY STOPPED AND THE ITEM WAS PROMPTLY RETRIEVED FROM THE PATIENT'S BODY. A NEW BLURR, LOT 10027659 WAS OPENED AND USED TO CONTINUE THE SURGERY. WHILE IN USE THE BLURR SHAVER STARTED RELEASING METAL SHAVINGS AND THE PROCEDURE WAS IMMEDIATELY STOPPED AND A DIFFERENT PRODUCT WAS USED TO FINISH THE PROCEDURE. THEY WERE NOT ABLE TO RETRIEVE THE METAL SHAVINGS FROM THE PATIENT'S BODY.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 9473539 ↗
• InjuryMay 3, 2018Metal Shedding Debris

  IT WAS REPORTED BY THE REP THAT WHEN THE SURGEON WAS IN THE REVERSE MODE WHILE USING THE 5.0 MM BURR, THE DEVICE WAS PRODUCING METAL SHAVINGS WHILE DEVICE WAS BEING USED IN THE PATIENT. USED A BASIC SHAVER TO CLEAN THE AREA AND RETRIEVED MOST OF THE SHAVINGS OUT OF THE PATIENT. THERE WAS NO X-RAYS TAKEN. PROCEDURE: ACROMIOPLASTY. PATIENT: (B)(6) YEAR OLD MALE. FOLLOW-UP INVESTIGATION: THE SURGEON USED THE SHAVER TO CLEAN UP THE METAL SHAVINGS HE WAS ABLE TO REMOVE AND STOPPED USING THE BLURR. THE SHAVER WAS THEN USED TO COMPLETE THE REST OF THE PROCEDURE.

  Patient problems: Foreign Body In Patient

  MAUDE report 7483539 ↗
• InjuryMay 3, 2018Metal Shedding Debris

  IT WAS REPORTED BY THE SALES REPRESENTATIVE THAT WHEN THE SURGEON WAS USING THE DEVICE IN THE REVERSE MODE FOR ABOUT 3 SECONDS, WHILE USING THE 5.0 MM BURR, THE DEVICE WAS PRODUCING METAL SHAVINGS. USED A BASIC SHAVER TO CLEAN THE AREA AND RETRIEVED MOST OF THE SHAVINGS OUT OF THE PATIENT. THERE WAS NO X-RAYS TAKEN. PROCEDURE: SHOULDER ROTATOR CUFF; PATIENT: (B)(6) MALE. FOLLOW-UP INVESTIGATION: THE SURGEON USED THE SHAVER TO CLEAN UP THE METAL SHAVINGS HE WAS ABLE TO REMOVE AND STOPPED USING THE BURR. THE SHAVER WAS THEN USED TO COMPLETE THE REST OF THE PROCEDURE.

  Patient problems: Foreign Body In Patient

  MAUDE report 7483530 ↗