Arthrex® AR-8500FOTRecalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00888867043848), received between Mar 1, 2021 and Nov 26, 2024 — classified as 17 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (9 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 26, 2024Break; Material Twisted/Bent; Break; Material Twisted/Bent

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC KNEE SURGERY THE INNER BURR WAS BENT. 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 20787292 ↗
• MalfunctionAug 22, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC SHOULDER SURGERY THE BURR TIP GEOMETRY BROKE OFF. ALL PARTS WERE RETRIEVED FROM THE PATIENT. 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 20043805 ↗
• MalfunctionJul 16, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT DURING AN ACJ AND ASAD CUFF REPAIR SURGERY THE 5 MM BURR BENT THE HOOD. 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 19751012 ↗
• MalfunctionJul 16, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT DURING AN ACJ AND ASAD CUFF REPAIR SURGERY THE 5 MM BURR BENT THE HOOD. 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 19751009 ↗
• MalfunctionJul 11, 2024Material Twisted/Bent; Material Twisted/Bent

  ***UPDATE KPILZ (B)(6) 2024: TWO MORE LINES WERE ADDED BECAUSE THE SURGEON USED TWO MORE DEVICES IN THE SAME SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19725026 ↗
• MalfunctionJun 28, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT DURING AN ACROMIOCLAVICULAR JOINT (ACJ) RESECTION SURGERY THE HOOD OF THE DEVICE BENT AND CAUGHT THE BURR CAUSING THE DEVICE TO BUCKLE AND BEND. 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. ACCORDING TO THE PROVIDED INFORMATION A SECOND SURGERY WAS REQUIRED. UPDATE AVOE 19-JUN-2024: IT WAS CONFIRMED THAT THE TIP OF THE 5 MM BURR BENT AND THAT NO SECOND SURGERY WAS REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19633173 ↗
• MalfunctionJun 27, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT DURING AN ACJ AND ASAD CUFF REPAIR SURGERY THE HOOD OF THE DEVICE BENT UPON MOVING UP INTO THE ACJ. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19625893 ↗
• MalfunctionMay 15, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE AR-8500FOT BURR HOOD BENT WHEN ACTIVATED INSIDE THE PATIENT. THE CASE WAS COMPLETED BY USING A SECOND BURR. SEE ATTACHED IMAGE.

  Patient problems: Insufficient Information

  MAUDE report 19322895 ↗
• MalfunctionMay 9, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A SHOULDER SURGERY THE TIP OF THE DEVICE WAS BENT AS SOON AS IT CAME IN CONTACT WITH THE BONE. THE SURGEON REPORTED THAT 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 19279324 ↗
• MalfunctionAug 11, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY THE BLADE DETACHED FROM THE ATTACHMENT. THE DETACHED BLADE COULD BE COMPLETELY REMOVED FROM THE PATIENT. 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 17514673 ↗
• MalfunctionApr 4, 2022Material Twisted/Bent

  IT WAS REPORTED ON (B)(6) 2022 BY A FACILITY REPRESENTATIVE VIA SEMS THAT AN AR-8500FOT BURR BENT AND TWISTED. THIS OCCURRED DURING A CASE AND BROKE IN THE JOINT SPACE. PER FACILITY: BURR WAS BEING USED IN THE POSTERIOR TIBIA. THE SURGEON EXPERIENCED SHAVINGS FROM THE BURR. THE GUARD ON THE BURR BENT AND TWISTED AROUND. THE EFFECT ON THE PATIENT WAS METAL SHAVERS IN THE KNEE JOINT DUE TO THE GUARD BENDING AND TWISTING."

  Patient problems: Foreign Body In Patient

  MAUDE report 13995224 ↗
• MalfunctionApr 7, 2021Therapeutic or Diagnostic Output Failure

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC SURGERY THERE WAS SLIGHT METAL ABRASION ON THE RIDGE. IT WAS FURTHER REPORTED THAT EVERYTHING COULD BE RETRIEVED OUT OF THE PATIENT. 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 11629717 ↗
• MalfunctionMar 22, 2021Break

  IT WAS REPORTED THAT THE TIP OF THE AR-8500FOT BURR BROKE OFF DURING A PROCEDURE.

  Patient problems: Insufficient Information

  MAUDE report 11547685 ↗
• MalfunctionMar 22, 2021Material Fragmentation

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC SURGERY THE DEVICE HAD METAL ABRASION. THE SURGEON WAS ABLE TO WASH OUT ALL THE FRAGMENTS AND FINISHED THE SURGERY 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 11545213 ↗
• MalfunctionMar 22, 2021Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC SURGERY THE DEVICE HAD METAL ABRASION. THE SURGEON WAS ABLE TO WASH OUT ALL THE FRAGMENTS AND FINISHED THE SURGERY 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 11545029 ↗
• MalfunctionMar 1, 2021Material Fragmentation

  IT WAS REPORTED THAT DURING ASK SURGERY CHIPPINGS CAME OFF OF THE MILLING MACHINE WITHOUT ANY FORCE AND GOT INTO THE PATIENT. THE CHIPPING PIECES HAVE BEEN FLUSHED FROM THE PATIENT RIGHT AWAY. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A FILE WHICH WAS USED FOR REMOVAL. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY. NO FURTHER INFORMATION RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11393506 ↗
• MalfunctionMar 1, 2021Material Fragmentation

  IT WAS REPORTED THAT DURING SURGERY THE SHAVER HIT THE AR-8500FOT AND METAL SPLINTERS GOT INTO PATIENT AND ARE REMAINING THERE. 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 11393493 ↗