Arthrex® AR-8400RBERecalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00888867043626), received between Apr 18, 2019 and May 26, 2026 — classified as 3 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (10 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 26, 2026Material Fragmentation

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT SURGERY THERE WERE METAL SHAVINGS PRODUCED IN THE KNEE JOINT. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. NO FURTHER INFORMATION RECEIVED. UPDATE 18-MAY-26: FURTHER INFORMATION WAS PROVIDED THAT THE ISSUE WAS DISCOVERED AFTER INTEROPERATIVE USE OF THE BURR AND METAL DEBRIS WAS VISIBLE ON THE MONITOR SCREEN. THE JOINT WAS CLEANED AND NO PARTS REMAINED INSIDE THE PATIENT. THE SURGERY WAS FINISHED SUCCESSFULLY WITH THE SAME 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 25278264 ↗
• MalfunctionJan 14, 2026Material Fragmentation

  ON 30TH DECEMBER 2025, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT FOR 2 UNITS OF AR-8400RBE, ROUND BURR, 8 FLUTE, 4.0 MM X 13 CM, THE SPHERICAL GRINDING HEAD WERE SHEDDING A LARGE AMOUNT OF CHIPS. THIS WAS DETECTED DURING USE IN AN ANKLE JOINT REPAIR SURGERY ON (B)(6) 2025. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AS ANOTHER BRAND'S PRODUCT WAS USED. THERE WAS NO PATIENT HARM AND NO SECONDARY PROCEDURE NEEDED. NO DUALWAVE OUTFLOW TUBING USED IN THE CASE, THERE WAS AN UNINTERRUPTED FLOW OF IRRIGATION THROUGH THE DEVICE DURING ITS USE. SHAVER CONSOLES AND HANDPIECES TYPE AND SERIAL NUMBER IS AR-8305/(B)(6) AND AR-8330H/(B)(6).

  Patient problems: Insufficient Information

  MAUDE report 24067561 ↗
• MalfunctionJan 14, 2026Material Fragmentation

  ON 30TH DECEMBER 2025, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT FOR 2 UNITS OF AR-8400RBE, ROUND BURR, 8 FLUTE, 4.0 MM X 13 CM, THE SPHERICAL GRINDING HEAD WERE SHEDDING A LARGE AMOUNT OF CHIPS. THIS WAS DETECTED DURING USE IN AN ANKLE JOINT REPAIR SURGERY ON (B)(6) 2025. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AS ANOTHER BRAND'S PRODUCT WAS USED. THERE WAS NO PATIENT HARM AND NO SECONDARY PROCEDURE NEEDED. NO DUALWAVE OUTFLOW TUBING USED IN THE CASE, THERE WAS AN UNINTERRUPTED FLOW OF IRRIGATION THROUGH THE DEVICE DURING ITS USE. SHAVER CONSOLES AND HANDPIECES TYPE AND SERIAL NUMBER IS (B)(6).

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24067557 ↗
• MalfunctionDec 9, 2025Melted; Melted

  IT WAS REPORTED THAT DURING THE BIPORTAL SPINAL ENDOSCOPY, THE PLASTIC OF THE BURR MELTED AT 8000 REVOLUTIONS PER MINUTE. 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 23757900 ↗
• MalfunctionSep 18, 2025Material Fragmentation; Material Fragmentation

  ON (B)(6) 2025, IT WAS REPORTED BY AN ARTHREX'S EMPLOYEE VIA AN EMAIL THAT FOR 1 UNIT OF AR-8400RBE, ROUND BURR, 8 FLUTE, 4.0 MM X 13 CM, AND 1 UNIT OF AR-8500RBE, ROUND BURR, 8 FLUTE, 5.0 MM X 13 CM, THE SPHERICAL GRINDING HEAD WERE SHEDDING A LARGE AMOUNT OF CHIPS. BOTH AR-8400RBE AND AR-8500RBE ENCOUNTERED THE SAME ISSUE. THIS WAS DETECTED DURING AN ANKLE ARTHROSCOPY SURGERY ON (B)(6) 2025. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY USING ANOTHER NEW AR-8400RBE AND AR-8500RBE. THERE WERE NO PATIENT HARM AND NO SECONDARY SURGERY NEEDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23086226 ↗
• MalfunctionSep 16, 2025Material Fragmentation; Material Fragmentation

  ON (B)(6) 2025, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA (B)(4) THAT AN AR-8400RBE BURR WAS USED NORMALLY AND DEBRIS WAS CREATED. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY SUBSTITUTING RF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23065575 ↗
• MalfunctionSep 9, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED DURING THE HIP ARTHROSCOPY THAT THE BALL END MILL PRODUCES A LOT OF METAL ABRASION. THERE ARE CHIPS IN THE SITE. ALL FRAGMENTS WERE RETRIEVED FROM 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 23006392 ↗
• MalfunctionJan 30, 2023Break; Material Fragmentation; Material Fragmentation

  IT WAS REPORTED ON (B)(6) 2023 BY A ARTHREX EMPLOYEE VIA SEMS THAT AN AR-8400RBE BURR IS PRODUCING DEBRIS WHEN USED. CASE INVOLVEMENT, DEVICE BREAKS DURING USE. ALL FRAGMENT RETRIEVED FROM PATIENT. NO PATIENT HARM AND NO SECONDARY PROCEDURE NEEDED. IT WAS COMPLETED BY USING OTHER TOOLS FROM OTHER COMPANY.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16263876 ↗
• MalfunctionDec 27, 2022Material Fragmentation

  IT WAS REPORTED ON 12/07/2022 BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-8400RBE BURR BROKE OFF DURING A CASE AND LEFT METAL SHAVINGS BEHIND. METAL SHAVINGS WERE REMOVED. CASE INVOLVEMENT, DEVICE BROKE DURING USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16051508 ↗
• MalfunctionMay 3, 2021Scratched Material

  IT WAS REPORTED THAT DURING AN ANKLE JOINT ARTHROSCOPY THE DEVICE PRODUCED METAL ABRASION. NO FRAGMENTS REMAINED INSIDE 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: Insufficient Information

  MAUDE report 11761666 ↗
• MalfunctionMar 1, 2021Break

  IT WAS REPORTED THAT DURING SAD SHOULDER SURGERY RIGHT SIDE THERE WAS A METAL ABRASION OF THE SHAVER ATTACHMENT. ALL ABRASION WAS REMOVED FROM PATIENT. NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY WAS 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 11393165 ↗
• InjuryFeb 26, 2020Therapeutic or Diagnostic Output Failure

  IT WAS REPORTED THAT DURING A MICOFRACTURE, THE BURR, AR-8400RBE, PRODUCED METAL SHAVINGS INSIDE OF THE KNEE JOINT OF THE PATIENT. THE CASE WAS COMPLETED BY USING ANOTHER MANUFACTURERS DEVICE. ADDITIONAL INFORMATION PROVIDED. ADDITIONAL INFORMATION PROVIDED 02/13/2020: IT WAS REPORTED THAT THE SURGEON COULD NOT CONFIRM IF ALL THE METAL SHAVINGS WERE REMOVED FROM THE PATIENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 9756707 ↗
• InjuryJan 14, 2020Material Fragmentation

  IT WAS REPORTED THAT DURING A KNEE ARTHROSCOPY PROCEDURE, THE ROUND BURR, AR-8400RBE, WAS BEING USED FOR A NOTCHPLASTY DURING AN ACL RECONSTRUCTION. DURING USE, METAL DEBRIS WAS BEING DISCHARGED FROM THE END OF THE BURR INTO THE KNEE. OR STAFF DISCARDED THE BURR INTO THE SHARPS CONTAINER. MOST OF THE DEBRIS WAS CLEANED OUT WITH A SHAVER AND A SECOND ROUND BURR, AR-8400RBE, WAS OPENED TO COMPLETE THE CASE. DURING USE, THIS ROUND BURR, WITH THE SAME LOT NUMBER AS THE FIRST, ALSO DISCHARGED METAL DEBRIS. AGAIN, THE SHAVINGS WERE REMOVED VIA SHAVER AND THE CASE WAS COMPLETED WITH A THIRD ROUND BURR, AR-8400RBE, FROM A DIFFERENT LOT NUMBER. ADDITIONAL INFORMATION PROVIDED 01/06/2020: PATIENT'S BONE WAS HARD. NO PUMP WAS USED DURING CASE; IT WAS ALL GRAVITY TUBING. THERE WAS NO INTERRUPTION OF FLUID DURING USE. THE REP CANNOT CONFIRM FOR SURE THAT THERE WAS DEBRIS LEFT BEHIND. THE STAFF AND SURGEON STATED THAT THEY GOT THE DEBRIS THEY COULD SEE OUT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 9585896 ↗
• InjuryApr 18, 2019Material Fragmentation

  IT WAS REPORTED THAT DURING AN ELBOW ARTHROSCOPY PROCEDURE, WHILE THE SURGEON WAS USING THE AR-8400RBE, BURR, HE COMPLAINED THAT THE BURR WAS PRODUCING METAL SHAVINGS INSIDE OF THE JOINT. MOST OF THE SHAVINGS WERE ABLE TO BE REMOVED VIA SUCTION BUT NOT ALL. PATIENT'S BONE QUALITY WAS MEDIUM. NO FURTHER DETAILS.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8526672 ↗