Arthrex® AR-8500FOERecalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00888867043824), received between Mar 16, 2017 and Mar 10, 2026 — classified as 2 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Break” (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. 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.

• MalfunctionMar 10, 2026Break

  ON 17-FEB-2026, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA (B)(4) THAT AN AR-8500FOE OVAL BURR BROKE AT THE END OF THE OUTER PROTECTIVE SLEEVE BY THE FLUTES OF THE BURR. THIS OCCURRED DURING USE IN A SHOULDER ARTHROSCOPIC CASE WITH NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24559694 ↗
• MalfunctionMar 2, 2026Use of Device Problem

  ON 10-FEB-2026, A SALES REPRESENTATIVE REPORTED VIA (B)(4) THAT THE AR-8500FOE FLUSHCUT OVAL FLUTE HAD THE OUTER SHEATH RIP OPEN. THIS ISSUE WAS DISCOVERED DURING A CASE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24481812 ↗
• MalfunctionJan 12, 2026Break

  ON 22-DEC-2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-8500FOE BURR BROKE UPON MAKING CONTACT WITH THE BONE. DISCOVERED DURING THE CASE, DEVICE SWAPPED, AND CASE COMPLETED WITH NO PATIENT EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24036608 ↗
• MalfunctionApr 4, 2025Break; Break

  IT WAS REPORTED THAT DURING A CUFF REPAIR SURGERY THE BURR SLEEVE BROKE DURING SHOULDER DECOMPRESSION. 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 21772163 ↗
• MalfunctionNov 20, 2024Break; Break

  ON 11/04/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT A AR-8500FOE BURR, FLUSHCUT OVAL, HAD THE SLEEVE OF THE BURR BENT. THE CASE WAS COMPLETED SUCCESSFULLY WITH NO IMPACT ON THE PATIENT. THIS WAS DISCOVERED DURING A PROCEDURE, WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20736267 ↗
• MalfunctionSep 16, 2024Break; Break

  IT WAS REPORTED THAT DURING A SHOULDER SURGERY THE BURR BROKE WHEN SHAVING OF THE ACROMION. ACCORDING TO THE SURGEON NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY OCCURRED. 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 20226786 ↗
• MalfunctionMay 15, 2024Break; Break

  IT WAS REPORTED DURING A ROTATOR CUFF REPAIR, THE BURR'S INNER SHAFT BROKE INTERNALLY WHILE IN USE. IT WAS REPLACED AND THE CASE WAS COMPLETED WITH NO FURTHER ISSUES.

  Patient problems: Insufficient Information

  MAUDE report 19321025 ↗
• MalfunctionJan 22, 2024Break; Break

  ON 1/3/2024, AN FDA MEDWATCH NOTIFICATION WAS RECEIVED VIA EMAIL. A FACILITY REPRESENTATIVE REPORTED THAT AN AR-8500FOE FLUSHCUT BURR GROUNDED INTO THE SHEATH AND BROKE THE SHEATH. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2023. NO FURTHER INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 18553856 ↗
• MalfunctionJan 19, 2024Break; Break

  ON 1/3/2024, AN FDA MEDWATCH NOTIFICATION WAS RECEIVED VIA EMAIL. A FACILITY REPRESENTATIVE REPORTED THAT AN AR-8500FOE FLUSHCUT BURR GROUNDED INTO THE SHEATH AND BROKE THE SHEATH. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2023. NO FURTHER INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 18544597 ↗
• InjurySep 21, 2020Break

  IT WAS REPORTED THAT DURING A (B)(6) 2020 ACL REVISION PROCEDURE THE SURGEON WAS USING AN AR-8500FOE (LOT 10596813) BURR FOR THE CHONDROPLASTY. REPORTER STATED THAT THE DEVICE WAS PRESSED UP AGAINST SOME SOFT TISSUE AND THE METAL SHEATH OF THE BURR MUST HAVE BEEN PRESSED INTO THE BURR BLADE WHILE IN MOTION. IT CAUGHT AND MANGLED THE SHEATH AND CAUSED METAL DEBRIS THROUGHOUT THE JOINT. THE DEVICE IS NOT BEING RELEASE FOR EVALUATION. THE FACILITY WILL BE NEEDING IT FOR THEIR INTERNAL REPORT. ADDITIONAL INFORMATION OBTAINED 8/14/20: THE BURR WAS OWNED BY THE FACILITY. THE PROCEDURE WAS A REVISION ACL. NO INFORMATION IS KNOWN WITH REGARD TO THE PATIENT'S ORIGINAL PRIOR PROCEDURE AS IT WAS PERFORMED BY A DIFFERENT SURGEON. THE ACL WAS BEING REVISED BECAUSE THE ACL TENDON FAILED. NO ARTHREX PRODUCTS WERE EXPLANTED DURING THE (B)(6) 2020 REVISION PROCEDURE. ALL METAL DEBRIS WAS REPORTED TO HAVE BEEN REMOVED FROM THE PATIENT VIA SHAVER SUCTION. ARTHREX REPORTING SALES REP WAS PRESENT DURING THE PROCEDURE. PICTURES OF THE DEVICE HAVE BEEN PROVIDED AND ARE ATTACHED TO THE FILE. ADDITIONAL INFORMATION OBTAINED 9/9/20: ARTHREX HAS RECEIVED AN FDA MEDWATCH LETTER (MW5096115) WHICH CONTAINS THE

  Patient problems: Foreign Body In Patient

  MAUDE report 10561733 ↗
• InjuryMar 16, 2017Bent; Component Falling; Material Fragmentation

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR WITH SUBACROMIAL DECOMPRESSION WITH ACROMIOPLASTY PROCEDURE, THE SURGEON STARTED THE OVAL FLUSH CUT 8 FLUTE BURR, AR-8500FOE, ON FORWARD AT 8000 RPMS. WITHOUT MUCH FORCE, THE BURR CONTACTED THE BONE AND THE FLUTE TWISTED AND BENT AROUND THE BURR CAUSING METAL SHAVINGS TO COME OFF FROM THE DEVICE AND FALL INTO THE PATIENT'S JOINT. THE SURGEON REMOVED AS MUCH OF THE METAL SHAVINGS AS HE COULD USING A SHAVER AND SUCTION BUT, THERE WERE STILL SOME MINUSCULE REMNANTS REMAINING. ANOTHER OVAL FLUSH CUT 8 FLUTE BURR OF THE SAME LOT WAS OPENED AND USED TO COMPLETE THE CASE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 6411474 ↗