Arthrex® AR-8500FOSRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00888867043831), received between Oct 9, 2018 and Feb 13, 2026 — classified as 3 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (5 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 13, 2026Break

  IT WAS REPORTED THAT DURING A SURGERY THE BURR BECAME DEFECTIVE. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. NO FURTHER INFORMATION WAS PROVIDED. ***UPDATE 28-JAN-2026 PICTURES WERE PROVIDED OF THE AFFECTED DEVICE, WHICH SHOW THAT THE TIP OF THE DEVICE IS DEFORMED AND BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24331854 ↗
• MalfunctionJun 13, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE AR-8500FOS BURR HOOD IS BENDING INTO THE FLUTES IN THE DEVICE WHILE DOING AN ACROMIOPLASTY. RPM¿S WERE 8000 IN REVERSE. BOTH SURGEONS STATED THAT THEY WERE LEVERING ON IT MODERATELY, BUT NO DIFFERENT THAN NORMAL. THE REP REPORTED THE HOOD WAS FOLDING INTO THE FLUTES, AND ALL PIECES OF THE DEVICE REMAINED INTACT. THE ISSUE HAS OCCURRED SIX TIMES IN THE PAST MONTH. THE CASES WERE COMPLETED BY USING NEW BURRS. THE REP STATED THEY CAN ONLY CONFIRM THE PRODUCT LOT NUMBER FOR ONE INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19529170 ↗
• MalfunctionJun 6, 2024Defective Device; Defective Device

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY THERE WAS A DEFLECTION OF THE BLADE PLATE (GUARD) FOR THE SHAVER. 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 19476047 ↗
• MalfunctionSep 12, 2023Material Fragmentation; Material Fragmentation

  ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-8500FOS BURR GOT TWISTED AND IN THE HOOD, CAUSING METAL SHAVINGS ON THE LENS. THIS WAS DISCOVERED DURING A CASE WITH NO PATIENT EFFECT. ALL FRAGMENTS REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17731286 ↗
• MalfunctionApr 25, 2023Break; Break

  IT WAS REPORTED THAT DURING A SAS SURGERY A PART OF THE DEVICE BROKE OFF INSIDE THE PATIENT. THE BROKEN PIECE WAS 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 16811096 ↗
• MalfunctionApr 7, 2021Material Fragmentation; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A SHOULDER SURGERY THE MILLING GUARD BECAME BENT INSIDE THE SHOULDER AND METAL DEBRIS WAS PRODUCED INSIDE THE SHOULDER. THE SPLINTERS COULD BE PARTIALLY REMOVED FROM THE SURGEON. THE SURGERY WAS FINISHED SUCCESSFULLY WITH THE SAME DEVICE ANYWAY. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: Failure of Implant; Foreign Body In Patient

  MAUDE report 11629787 ↗
• InjurySep 25, 2019Material Fragmentation; Unintended Collision

  IT WAS REPORTED THAT DURING A PROCEDURE, THE ROTATING PORTION OF THE OVAL BURR, AR-8500FOS, MADE CONTACT WITH THE HOOD AND TORQUED THE HOOD AROUND THE FLUTED BURR. THIS HAPPENED TWICE IN THIS CASE WITH TWO OF THE SAME BURRS FROM DIFFERENT LOT NUMBERS. NO ADVERSE EFFECT TO THE PATIENT. ADDITIONAL INFORMATION PROVIDED 9/3/19: PROCEDURE WAS AN RCR. BONE QUALITY WAS DECENT, BUT NOT GREAT. THE BURRS PRODUCED DEBRIS AND TINY METAL PARTICLES WERE LEFT IN JOINT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 9118590 ↗
• InjurySep 25, 2019Material Fragmentation; Unintended Collision

  IT WAS REPORTED THAT DURING A PROCEDURE, THE ROTATING PORTION OF THE OVAL BURR, AR-8500FOS, MADE CONTACT WITH THE HOOD AND TORQUED THE HOOD AROUND THE FLUTED BURR. THIS HAPPENED TWICE IN THIS CASE WITH TWO OF THE SAME BURRS FROM DIFFERENT LOT NUMBERS. NO ADVERSE EFFECT TO THE PATIENT. ADDITIONAL INFORMATION PROVIDED 9/3/2019: PROCEDURE WAS AN ROTATOR CUFF REPAIR. BONE QUALITY WAS DECENT, BUT NOT GREAT. THE BURRS PRODUCED DEBRIS AND TINY METAL PARTICLES WERE LEFT IN JOINT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 9118574 ↗
• InjuryOct 9, 2018Material Fragmentation; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A SHOULDER SCOPE PROCEDURE, THE SURGEON COMPLETED THE ACROMIOPLASTY BY USING THE AR-8500FOS, OVAL FLUSHCUT BURR WITHOUT ANY ISSUE. THE SURGEON THEN WENT TO BURR THE DISTAL CLAVICLE. AS THE SURGEON PLACED THE BURR BETWEEN THE ACROMION AND CLAVICLE AND ACTIVATED THE BURR, THE BACK OF THE SHEATH TWISTED AND METAL DEBRIS SHOT OUT OF THE DEVICE. THE SURGEON COMMUNICATED TO THE REP THAT NOTHING FELT OR SEEMED ABNORMAL WITH THE BURR DURING USE. THE SURGEON WAS ABLE TO RETRIEVE SOME OF THE METAL SHAVINGS FROM THE PATIENT BY USING ANOTHER MANUFACTURER'S SHAVER. THE REP CONFIRMED THAT NOT ALL OF THE SHAVINGS WERE FULLY RETRIEVED FROM INSIDE THE PATIENT. THE CASE WAS COMPLETED BY USING ANOTHER MANUFACTURER'S BURR. THE REP STATED IT IS UNKNOWN HOW THE DEVICE BECAME TWISTED. THE REP REPORTED THAT THE SURGEON DID NOT DEVIATE FROM THE PROPER SURGICAL TECHNIQUE. THE REP CONFIRMED THAT THE DEVICE WILL BE RETURNING FOR EVALUATION.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 7947408 ↗