Arthrex® AR-8400BCRecalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00888867043466), received between May 3, 2018 and Sep 16, 2026 — classified as 2 injuries, 16 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 16, 2026Material Fragmentation

  Patient problems: Insufficient Information

  MAUDE report 50788481 ↗
• MalfunctionSep 16, 2026Material Fragmentation

  Patient problems: Insufficient Information

  MAUDE report 50787101 ↗
• MalfunctionDec 29, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  ON 8-DEC-2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-8400BC BONE CUTTER IS STICKING AT THE MOUTH AND NOT OSCILLATING. NOTICED DURING A CASE, SWAPPED, AND CASE COMPLETED WITH NO PATIENT EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23906502 ↗
• MalfunctionDec 29, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  ON 8-DEC-2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-8400BC BONE CUTTER IS STICKING AT THE MOUTH AND NOT OSCILLATING. NOTICED DURING A CASE, SWAPPED, AND CASE COMPLETED WITH NO PATIENT EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23906490 ↗
• MalfunctionDec 29, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  ON 8-DEC-2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-8400BC BONE CUTTER IS STICKING AT THE MOUTH AND NOT OSCILLATING. NOTICED DURING A CASE, SWAPPED, AND CASE COMPLETED WITH NO PATIENT EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23906489 ↗
• MalfunctionDec 29, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  ON 8-DEC-2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-8400BC BONE CUTTER IS STICKING AT THE MOUTH AND NOT OSCILLATING. NOTICED DURING A CASE, SWAPPED, AND CASE COMPLETED WITH NO PATIENT EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23906488 ↗
• MalfunctionDec 29, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  ON (B)(6) 2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-8400BC BONE CUTTER IS STICKING AT THE MOUTH AND NOT OSCILLATING. NOTICED DURING A CASE, SWAPPED, AND CASE COMPLETED WITH NO PATIENT EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23906485 ↗
• MalfunctionDec 24, 2025Break; Break

  IT WAS REPORTED THAT DURING THE ANKLE ARTHROSCOPY, THE DEVICE BROKE INSIDE THE JOINT. THE BROKEN PIECES 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 23888628 ↗
• MalfunctionFeb 5, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING A BROSTROM SURGERY THE SHAVER SHEDS METAL CHIPS IN THE ANKLE JOINT. 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. UPDATE (B)(6) 16-JAN-2025: FURTHER INFORMATION WAS PROVIDED THAT THE PIECES WERE RETRIEVED OUT OF THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21311379 ↗
• InjuryJun 21, 2024Break; Break

  UPDATE 23-JUL-2024: DURING A PHONE CALL THE FOLLOWING ADDITIONAL INFORMATION WERE MADE AVAILABLE. IT WAS FURTHER CONFIRMED THAT ALL DEVICES AR-8500OBE, AR-8400BC AND AR-6420CEX FAILED DURING THE SAME SURGERY, BECAUSE THE SURGEON HAD TO INCREASE THE PRESSURE AS THE PATIENT BONE WAS VERY HARD.

  Patient problems: Insufficient Information

  MAUDE report 19588688 ↗
• MalfunctionJun 19, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A PROCEDURE, THE AR-8400BC BENT. THE CASE WAS COMPLETED BY USING A NEW AR-8400BC.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19566575 ↗
• MalfunctionFeb 7, 2024Defective Device; Defective Device

  ON (B)(6) 2024, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA EMAIL THAT (2) AR-8400BC BONE CUTTER BECAME DAMAGED DURING A PROCEDURE ON (B)(6) /2024. NO FURTHER INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 18661375 ↗
• MalfunctionFeb 7, 2024Defective Device; Defective Device

  ON (B)(6) 2024, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA EMAIL THAT (2) AR-8400BC BONE CUTTER BECAME DAMAGED DURING A PROCEDURE ON (B)(6) 2024. NO FURTHER INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 18661365 ↗
• MalfunctionJan 26, 2024Material Fragmentation; Material Fragmentation

  ON (B)(6) 2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS (B)(4) THAT, DURING A CASE, THE BONE CUTTER (AR-8400BC) WAS PRODUCING METAL SHAVINGS INTO THE JOINT. THE DEVICE WAS REPLACED AND THE CASE WAS COMPLETED WITH NO ADVERSE EFFECT TO THE PATIENT. ADDITIONAL INFORMATION REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18586274 ↗
• MalfunctionOct 25, 2023Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY SURGERY THE TIP OF THE DEVICE GOT BENT. 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 18004384 ↗
• MalfunctionJul 18, 2023Defective Device; Defective Device

  ON (B)(6) 2023, IT WAS REPORTED BY A ARTHREX EMPLOYEE VIA SEMS THAT AN AR-8400BC BONE CUTTER AND AR-8400PR POWERRASP DO NOT WORK. THE SAME PROBLEM CONTINUES 2 TIMES. THIS WAS DISCOVERED DURING A CASE, USED A NEW PRODUCT AND THE CASE IS COMPLETED. NO PATIENT HARMS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17343499 ↗
• MalfunctionSep 19, 2022Break

  ON (B)(6) 2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT A AR-8400BC BONE CUTTER BROKE. THIS OCCURRED ON (B)(6) 2022 DURING A SUB-ACROMIAL DECOMPRESSION OF THE SHOULDER WHEN THE SHAFT OF THE DEVICE BROKE IN HALF. THE PATIENT HAD GOOD BONE QUALITY, AND THE BROKEN FRAGMENT WAS RETRIEVED. THE CASE WAS COMPLETED USING ANOTHER BONE CUTTER. THERE WAS NO PATIENT EFFECT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15445804 ↗
• InjuryMay 3, 2018Break

  IT WAS REPORTED THAT THE BONE CUTTER BROKE IN THE HUB DURING SURGERY. ALL BROKEN PIECES WERE RETRIEVED FROM THE PATIENT. HOWEVER, THE PATIENT WAS BURNT. OPENED ANOTHER BONE CUTTER AND COMPLETED THE PROCEDURE. SHOULDER SCOPE. FOLLOW UP INFORMATION: SALES REP WAS NOTIFIED ABOUT THE INCIDENT ON (B)(4) 2013. IT HAS BEEN REPORTED THAT THE ACCOUNT/NURSING DIRECTOR DID NOT KNOW THE MEANS OF HOW THE PATIENT WAS BURNT. ACCOUNT REPORTED TO THE SALES REP THAT THE BURN WAS LOCATED AT ONE OF THE INCISIONS PORTALS ON THE ANTERIOR ASPECT OF THE SHOULDER. IT WAS REPORTED TO BE A MINOR SUPERFICIAL BURN WHICH WAS TREATED PER FACILITY POLICY. PATIENT WAS DISCHARGED SAME DAY.

  Patient problems: Injury

  MAUDE report 7483540 ↗