Arthrex® AR-6500RBERecalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00888867039452), received between May 9, 2022 and Dec 9, 2025 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Break” (7 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 9, 2025Material Fragmentation; Material Fragmentation

  ON 11/21/2025, A FACILITY REPRESENTATIVE REPORTED VIA (B)(4) THAT THE SURGEON HAD ISSUES WITH THE AR-6500RBE 8-FLUTE 5.0MM X 19CM ROUND BURR SHEDDING METAL FRAGMENT DEBRIS IN BOTH FORWARD AND REVERSE AT 8000 RPM DURING A CAM RESECTION WHILE PERFORMING A HIP ARTHROSCOPY. THE SIZE OF THE FRAGMENTS WAS TINY, LIKE SPECKS. NO PATIENT WAS AFFECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23759380 ↗
• MalfunctionAug 7, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING AN HIP ARTHROSCOPIC SURGERY PLASTIC DEBRIS WAS PRODUCED. THE PLASTIC WAS VISIBLE IN THE CAMERA AND COULD BE REMOVED IN TIME. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH 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 22742510 ↗
• MalfunctionAug 7, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING AN HIP ARTHROSCOPIC SURGERY PLASTIC DEBRIS WAS PRODUCED. THE PLASTIC WAS VISIBLE IN THE CAMERA AND COULD BE REMOVED IN TIME. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH 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 22742506 ↗
• MalfunctionJan 2, 2025Break; Break

  ON 12/06/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT (QTY. (B)(4)) OF AN AR-6500RBE ROUND BURR, HL, 8 FLUTE, 5.0 MM X 19 CM HAD THE BURR BREAK DURING A CASE AND FELL WHERE THE SHAVER HANDLE CONNECTS. NOTHING FELL INSIDE THE PATIENT. THIS WAS DISCOVERED DURING A PROCEDURE, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION WAS RECEIVED ON 12/12/2024: IT WAS CONFIRMED THAT ONLY A (QTY. (B)(4)) OF AN AR-6500RBE ROUND BURR BROKE DURING A HIP ARTHROSCOPY PROCEDURE ON (B)(6)2024. NO DEBRIS WAS PRODUCED WHILE THE DEVICES WERE IN USE. THE CASE WAS COMPLETED SUCCESSFULLY, AND NO FURTHER INFORMATION WAS PROVIDED. THERE WAS NO CASE DELAY. NO ADVERSE EFFECTS ON THE PATIENT WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21057897 ↗
• MalfunctionJan 2, 2025Break; Break

  ON (B)(6) 2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT (QTY. 10) OF AN AR-6500RBE ROUND BURR, HL, 8 FLUTE, 5.0 MM X 19 CM HAD THE BURR BREAK DURING A CASE AND FELL WHERE THE SHAVER HANDLE CONNECTS. NOTHING FELL INSIDE THE PATIENT. THIS WAS DISCOVERED DURING A PROCEDURE, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION WAS RECEIVED ON 12/12/2024: IT WAS CONFIRMED THAT ONLY A (QTY. 4) OF AN AR-6500RBE ROUND BURR BROKE DURING A HIP ARTHROSCOPY PROCEDURE ON (B)(6)2024. NO DEBRIS WAS PRODUCED WHILE THE DEVICES WERE IN USE. THE CASE WAS COMPLETED SUCCESSFULLY, AND NO FURTHER INFORMATION WAS PROVIDED. THERE WAS NO CASE DELAY. NO ADVERSE EFFECTS ON THE PATIENT WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21057866 ↗
• MalfunctionJan 2, 2025Break; Break

  ON (B)(6)2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT (QTY. 10) OF AN AR-6500RBE ROUND BURR, HL, 8 FLUTE, 5.0 MM X 19 CM HAD THE BURR BREAK DURING A CASE AND FELL WHERE THE SHAVER HANDLE CONNECTS. NOTHING FELL INSIDE THE PATIENT. THIS WAS DISCOVERED DURING A PROCEDURE, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION WAS RECEIVED ON 12/12/2024: IT WAS CONFIRMED THAT ONLY A (QTY. 4) OF AN AR-6500RBE ROUND BURR BROKE DURING A HIP ARTHROSCOPY PROCEDURE ON (B)(6) 2024. NO DEBRIS WAS PRODUCED WHILE THE DEVICES WERE IN USE. THE CASE WAS COMPLETED SUCCESSFULLY, AND NO FURTHER INFORMATION WAS PROVIDED. THERE WAS NO CASE DELAY. NO ADVERSE EFFECTS ON THE PATIENT WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21057652 ↗
• MalfunctionJan 2, 2025Break; Break

  ON 12/06/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT (QTY. (B)(4) OF AN AR-6500RBE ROUND BURR, HL, 8 FLUTE, 5.0 MM X 19 CM HAD THE BURR BREAK DURING A CASE AND FELL WHERE THE SHAVER HANDLE CONNECTS. NOTHING FELL INSIDE THE PATIENT. THIS WAS DISCOVERED DURING A PROCEDURE, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION WAS RECEIVED ON 12/12/2024: IT WAS CONFIRMED THAT ONLY A (QTY. (B)(4) OF AN AR-6500RBE ROUND BURR BROKE DURING A HIP ARTHROSCOPY PROCEDURE ON (B)(6) 2024. NO DEBRIS WAS PRODUCED WHILE THE DEVICES WERE IN USE. THE CASE WAS COMPLETED SUCCESSFULLY, AND NO FURTHER INFORMATION WAS PROVIDED. THERE WAS NO CASE DELAY. NO ADVERSE EFFECTS ON THE PATIENT WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21057619 ↗
• MalfunctionDec 11, 2024Break; Break

  IT WAS REPORTED THAT DRING A HAS SURGERY THE DEVICE BROKE INSIDE. 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 20906145 ↗
• MalfunctionDec 11, 2024Break; Break

  IT WAS REPORTED THAT DRING A HAS SURGERY THE DEVICE BROKE INSIDE. 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 20906114 ↗
• MalfunctionOct 12, 2023Material Fragmentation; Material Fragmentation

  ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS-06031381 THAT AN AR-6500RBE ROUND BURRS METAL SHARD CAME OFF OF THE BURR. THIS OCCURRED DURING A HIP ARTHROSCOPY ON (B)(6) 2023 UPON IMMEDIATE USE OF THE PRODUCT. ALL FRAGMENTS WERE RETRIEVED AND THE CASE WAS COMPLETED. THERE WAS NO PATIENT EFFECT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17918637 ↗
• MalfunctionMay 23, 2022Break

  IT WAS REPORTED THAT DURING AN OSTEOPHYTE RESECTION SURGERY THE DEVICES BROKE OFF INSIDE THE PATIENT. THE BROKEN PIECES WERE RETRIEVED FROM 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 14468739 ↗
• MalfunctionMay 9, 2022Detachment of Device or Device Component

  ON (B)(6) 2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-6500RBE ROUND BURR HAD AN ISSUE, THE HIP BURR HAD THE CLEAR SHROUD FELL OFF DURING A CASE. THE SURGEON WAS ABLE TO RETRIEVE THE SHROUD AND COMPLETE THE CASE. THIS WAS DISCOVERED DURING USE WITH NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14337040 ↗