Arthrex® AR-8500EXRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00888867043817), received between Aug 10, 2021 and Jun 26, 2024 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 26, 2024Break; Break

  IT WAS REPORTED THAT DURING A HAS SURGERY THE SHAVER ATTACHMENT IS BROKEN OFF. THE DEVICE DID NOT BREAK INSIDE 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 19617815 ↗
• MalfunctionJul 28, 2023Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY SURGERY METAL SHAVINGS WERE PRODUCED WITH THE DEVICES. ALL FRAGMENTS WERE RETRIEVED FROM THE PATIENT. 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 OR DO A SECOND SURGERY. ***UPDATE, KHE, (B)(6) 2023: 12 ORIGINAL PACKED DEVICES WERE RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17413848 ↗
• MalfunctionOct 24, 2022Break

  IT WAS REPORTED THAT DURING A KNEE ARTHROSCOPY MENISCUS SURGERY THE TIP OF THE DEVICE BROKE OFF. ALL BROKEN PARTS WERE RETRIEVED FROM THE PATIENT. 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 OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15657480 ↗
• MalfunctionDec 7, 2021Material Fragmentation

  IT WAS REPORTED THAT DURING A MENISCUS RESECTION SURGERY THE DEVICE CONTAINED FINE METAL SHAVINGS AND WHEN THE DEVICE WAS INSERTED INTO THE JOINT, METAL CHIPS WERE SPRINKLED INSIDE THE PATIENT BEFORE THE INSTRUMENT WAS ACTIVATED. ALL FRAGMENTS COULD BE RETRIEVED FROM THE PATIENT. 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 OR DO A SECOND SURGERY.

  Patient problems: Foreign Body In Patient

  MAUDE report 12953267 ↗
• MalfunctionAug 10, 2021Break

  THE FOLLOWING WAS FOUND DURING A MAUDE REVIEW: IT WAS REPORTED THAT DURING A RIGHT ACL RECONSTRUCTION ARTHROSCOPY PROCEDURE, WHEN THE SURGEON WAS USING A 5. 0MM ARTHREX SHAVER, AR-8500EX, LOT: 10453589, A SECTION OF THE SHAVER'S OUTER SHEATH BROKE OFF AND WAS DISCOVERED WHILE SURGEON WAS CLOSING THE SUBCUTANEOUS TISSUE. THE SURGEON WAS ABLE TO RETRIEVE THE SECTION IN ITS ENTIRETY AFTER IT WAS VIEWED UNDER FLUOROSCOPY. THE FIRST LAYER OF SUBCUTANEOUS TISSUE HAD BEEN CLOSED AT THIS POINT AND HAD TO BE REOPENED AND THE SHEATH FRAGMENT REMOVED. THE PATIENT WAS STILL UNDER ANESTHESIA AT THIS TIME. THE SUBCUTANEOUS TISSUE AND SKIN LAYERS WERE CLOSED BY THE SURGEON WITHOUT FURTHER INCIDENT.

  Patient problems: Insufficient Information

  MAUDE report 12300604 ↗