Arthrex® AR-8500BCRecalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00888867043732), received between Nov 9, 2022 and Jan 12, 2026 — classified as 16 malfunctions.

The most frequently reported specific device problem is “Break” (13 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 12, 2026Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC SHOULDER SURGERY THE INNER PART OF THE BONE CUTTER BROKE. THE DEVICE DID NOT BREAK INSIDE THE PATIENT. 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 24036468 ↗
• MalfunctionDec 31, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING THE SHOULDER ARTHROSCOPY, THE DEVICE PRODUCED METAL DEBRIS IN THE PATIENT. ATTEMPTS WERE MADE TO COMPLETELY REMOVE THE DEBRIS FROM THE PATIENT; HOWEVER, IT CANNOT BE DEFINITIVELY CONFIRMED THAT NO METAL DEBRIS REMAINED. 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 23933793 ↗
• MalfunctionJan 21, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING AN ANKLE ARTHROSCOPHY SURGERY THE SHAVER SHEDS METAL CHIPS DURING THE PROCEDURE. 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. (B)(6) 2024 -SAC: RECEIVED FURTHER INFORMATION FROM CATARINA LAPA THAT NO SECOND SURGERY WAS NECESSARY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21198815 ↗
• MalfunctionMay 27, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ANKLE ARTHROSCOPY THE INNER PART OF THE BONE CUTTER BROKE. 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. *** UPDATE 25-MAY-2023 NEN: FURTHER INFORMATION REVEALED THAT THE BONE CUTTER BROKE INSIDE THE PATIENT. THE BROKEN PIECES WERE RETRIEVED FROM PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19400613 ↗
• MalfunctionJan 9, 2024Break; Break

  ON 12/12/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT THE BASE OF (2) AR-8500BC BONE CUTTER SNAPPED IN HALF. THIS WAS DISCOVERED DURING A SUB ACROMIAL DECOMPRESSION PROCEDURE. NO FURTHER INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 18475253 ↗
• MalfunctionJan 5, 2024Break; Break

  ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT THE BASE OF (2) AR-8500BC BONE CUTTER SNAPPED IN HALF. NO FURTHER INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 18458983 ↗
• MalfunctionJan 4, 2024Break; Break

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR SURGERY THE SHAVER BLADE BROKE OFF. 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. UPDATE 11-DEC-2023 DW FURTHER INFORMATION WERE PROVIDED THAT THE DEVICE BROKE OFF OUTSIDE THE PATIENT AND NO FRAGMENTS HAD TO BE RETRIEVED OUT OF THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18443909 ↗
• MalfunctionJan 4, 2024Break; Break

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR SURGERY THE SHAVER BLADE BROKE OFF. 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. UPDATE 11-DEC-2023 DW. FURTHER INFORMATION WERE PROVIDED THAT THE DEVICE BROKE OFF OUTSIDE THE PATIENT AND NO FRAGMENTS HAD TO BE RETRIEVED OUT OF THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18443905 ↗
• MalfunctionJan 3, 2024Break; Break

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY MULTIPLE BLADES BROKE OFF AT THE SHAFT OUTSIDE THE PATIENT. THE BROKEN PIECES WERE RETRIEVED OUT OF THE PATIENTS. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. 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 18435931 ↗
• MalfunctionJan 3, 2024Break; Break

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY MULTIPLE BLADES BROKE OFF AT THE SHAFT OUTSIDE THE PATIENT. THE BROKEN PIECES WERE RETRIEVED OUT OF THE PATIENTS. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. 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 18435930 ↗
• MalfunctionJan 2, 2024Break; Break

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY MULTIPLE BLADES BROKE OFF AT THE SHAFT OUTSIDE THE PATIENT. THE BROKEN PIECES WERE RETRIEVED OUT OF THE PATIENTS. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. 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 18429259 ↗
• MalfunctionDec 26, 2023Break; Break

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY THE BLADE BROKE OFF AT THE SHAFT OUTSIDE THE PATIENT. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A DIFFERENT DEVICE. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY. *** UPDATE DW 05-DEC-2023 FURTHER INFORMATION WERE PROVIDED THAT THREE DEVICES BROKE DURING THE SURGERY AND ALL PIECES WERE RETRIEVED OUT OF THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18394361 ↗
• MalfunctionDec 26, 2023Break; Break

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY THE BLADE BROKE OFF AT THE SHAFT OUTSIDE THE PATIENT. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A DIFFERENT DEVICE. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY. UPDATE DW 05-DEC-2023. FURTHER INFORMATION WERE PROVIDED THAT THREE DEVICES BROKE DURING THE SURGERY AND ALL PIECES WERE RETRIEVED OUT OF THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18394360 ↗
• MalfunctionDec 26, 2023Break; Break

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY THE BLADE BROKE OFF AT THE SHAFT OUTSIDE THE PATIENT. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A DIFFERENT DEVICE. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY. UPDATE (B)(6) 2023 FURTHER INFORMATION WERE PROVIDED THAT THREE DEVICES BROKE DURING THE SURGERY AND ALL PIECES WERE RETRIEVED OUT OF THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18394357 ↗
• MalfunctionJan 23, 2023Break

  ADDITIONAL INFORMATION PROVIDED ON 01/06/2023, IT WAS REPORTED THAT A ROTATOR CUFF REPAIR WITH DISTAL CLAVICLE EXCISION OCCURRED ON (B)(6) 2023. ALL FRAGMENTS OF THE BROKEN DEVICE WERE RETRIEVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16223349 ↗
• MalfunctionNov 9, 2022Material Fragmentation

  IT WAS REPORTED THAT DURING AN AUTOCART ANKLE ARTHROSCOPY SURGERY THE DEVICE WAS USED FOR A FEW SECONDS ON THE BONE CARTILAGE AND THEN STARTED RIGHT AWAY TO SHOW SOME VERY SMALL METAL PARTICLES TO COME OFF. METAL PARTICLES REMAINED INSIDE THE PATIENT. 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 15758562 ↗