Arthrex® AR-400Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 00888867223318), received between Jun 2, 2020 and Aug 14, 2026 — classified as 1 injury, 22 malfunctions.

The most frequently reported specific device problem is “Break” (6 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 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 14, 2026Break

  Patient problems: Insufficient Information

  MAUDE report 50260174 ↗
• MalfunctionJul 29, 2026Break; Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50070238 ↗
• MalfunctionFeb 18, 2026Overheating of Device

  IT WAS REPORTED THAT DURING A SURGERY, THE DEVICE OVERHEATED AND BECAME VERY HOT. IT HAS ALSO NOT BEEN POSSIBLE TO DISASSEMBLE THE DEVICE. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. NO FURTHER INFORMATION RECEIVED. UPDATE 05-FEB-2026 - FURTHER INFORMATION WAS RECEIVED: IT WAS REPORTED THAT DURING THE REVERSE TOTAL SHOULDER ARTHROPLASTY, THE DEVICE OVERHEATED AND BECAME VERY HOT. IT HAS ALSO NOT BEEN POSSIBLE TO DISASSEMBLE THE DEVICE. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A DIFFERENT DEVICE FROM ANOTHER MANUFACTURER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24377072 ↗
• MalfunctionJan 20, 2026Break

  ON 08-JAN-2026, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA (B)(4) THAT AN AR-400 DRILLSAW SPORTS 400 SYSTEM HANDPIECE BROKE INTERNALLY. IT WAS REPORTED THAT WHEN REMOVING THE GRAFT USING THE SAW, THE MOTOR MALFUNCTIONED, CAUSING THE SPORTS 400 HANDPIECE TO BREAK INTERNALLY. THIS WAS DISCOVERED DURING AN HTH TECHNIQUE KNEE ARTHROSCOPY PROCEDURE WITH NO PATIENT HARM. ADDITIONAL INFORMATION PROVIDED 13-JAN-2026: IT WAS FURTHER REPORTED THAT THIS WAS DISCOVERED AFTER USE, UPON FINISHING THE SURGERY AND REMOVING THE SAW BLADE, THE BREAKAGE OF THE PINS ON THE AR-400 HANDPIECE WAS OBSERVED AND THEREFORE IT IS NOT KNOWN WHEN THE BREAKAGE OCCURRED. THE BLADE DID NOT BREAK WITHIN THE PATIENT AND NO FRAGMENTS WERE PRODUCED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24117667 ↗
• MalfunctionDec 23, 2025Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT DURING A FOOT SURGERY THE AR-400 HANDPIECE GOT VERY HOT, AND THE K-WIRE DIDN'T APPEAR TO ROTATE NORMALLY AND CREATED A SORT-OF METAL "DUST" AND EVEN SMALL METAL "FLAKES". IT CLEARLY JAMMED OR OBSTRUCTED THE K-WIRE FROM NORMAL ROTATION. AFTER NORMAL TROUBLESHOOTING, THE SURGEON SWITCH TO ANOTHER AR-400PD, AND EVERYTHING RAN SMOOTHLY. 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 23879838 ↗
• MalfunctionDec 10, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT WHILE MILLING AN INTRAMEDULLARY NAIL, THE GUIDE BECAME STUCK AND, WHEN REMOVED, A SMALL TUBE CAME OUT. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. NO FURTHER INFORMATION RECEIVED. UPDATE AVOE 13-NOV-2025 IT WAS CONFIRMED THAT THE FAILURE OCCURRED ON THE 23RD OF OCTOBER DURING A FEMUR FRACTURE WITH INTRAMEDULLARY NAIL SURGERY. 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 23771342 ↗
• MalfunctionJul 30, 2025Overheating of Device; Overheating of Device

  ON 07/08/2025, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA (B)(4) THAT AN AR-400 DRILLSAW SPORTS 400 SYSTEM OVERHEATED. THIS OCCURRED DURING AN ACL PROCEDURE.

  Patient problems: Insufficient Information

  MAUDE report 22663461 ↗
• MalfunctionFeb 4, 2025Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT DURING A FOOT SURGERY THE HANDPIECE WAS NOISY AND THE HANDLE GOT HOT WHILE SAWING AND DRILLING. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. 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 21305484 ↗
• MalfunctionOct 29, 2024Defective Component; Defective Device; Defective Component; Defective Device

  IT WAS REPORTED THAT THE BOTH DEVICES ARE DEFECTIVE AND THEY WOBBLE. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THERE WAS NO CASE INVOLVEMENT REPORTED. NO FURTHER INFORMATION RECEIVED. UPDATE, KHE, (B)(6) 2024. RECEIVE FURTHER INFORMATION. IT WAS REPORTED THAT THE MACHINE RUNS IRREGULARLY FROM THE SAW BLADE DURING USE. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. UPDATE, KHE, (B)(6) 2024. FURTHER INFORMATION RECEIVED. THE EVENT OCCURRED DURING A REPOSITIONING OSTEOTOMY FEMUR. NO PIECE BROKE OFF INSIDE THE PATIENT. THE SURGERY WAS FINISHED SUCCESSFULLY WITH THE CLAIMED 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 20556280 ↗
• MalfunctionSep 30, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ON 09/02/2024, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA SEMS-06651920 THAT AN AR-400 DRILLSAW SPORTS 400 SYSTEM DETACHED. THIS OCCURRED DURING A CASE. THERE WAS NO ADDITIONAL INFORMATION WAS PROVIDED, AND ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 20332785 ↗
• MalfunctionSep 11, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE DEVICE AND ITS ATTACHMENT HAVE WEDGED AND CAN NO LONGER BE SEPARATED. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. THERE WAS NO CASE INVOLVEMENT REPORTED. NO FURTHER INFORMATION RECEIVED. UPDATE KPILZ 05-SEP-2024: IT WAS REPORTED THAT DURING AN ACL SURGERY THE DEVICE AND ITS ATTACHMENT HAVE WEDGED AND CAN NO LONGER BE SEPARATED. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW 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 20192382 ↗
• MalfunctionJun 24, 2024Break; Break

  ON (B)(6) 2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-400 DRILL SAW HANDPIECE HAD A PIECE BREAK OFF BY THE BATTERY ATTACHMENT. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19594031 ↗
• MalfunctionJun 18, 2024Unstable; Unstable

  ON 9/16/2022, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA SEMS THAT AN AR-400 DRILL SAW SPORTS 400 HAD AN ISSUE, IT WOULDN'T HOLD. THIS WAS DISCOVERED DURING USE WITH NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19564079 ↗
• MalfunctionMay 28, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT A WIRE JAMS IN THE BODY. THIS WAS NOTICED AFTER THE SURGERY. THERE WAS NO HARM FOR THE PATIENT, OPERATOR OR THIRD PARTY REPORTED. ALSO THERE WAS NO CASE INVOLVEMENT REPORTED. NO FURTHER INFORMATION RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19404779 ↗
• MalfunctionMay 10, 2024Break; Break

  ON 05/07/2024, ADDITIONAL INFORMATION WAS PROVIDED BY A DISTRIBUTOR VIA EMAIL WHO STATED THAT THE PROCEDURE PERFORMED WAS AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION, BONE-TENDON-BONE TECHNIQUE. AT THE TIME OF USE THE SAW ATTACHMENT DID NOT FIT PROPERLY AND WAS UNSUCCESSFUL IN USE. PHOTOS WERE TAKEN AND ARE ATTACHED. NO FRAGMENTS REMAINED IN THE PATIENT AND TO COMPLETE THE PROCEDURE, THE BONE-TENDON-BONE TECHNIQUE WAS CHANGED AND SEMITENDINOSUS GRAFT WAS TAKEN OUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19294128 ↗
• MalfunctionMar 26, 2024Break; Break

  UPDATE DW 26-MAR-2024: FURTHER INFORMATION WERE PROVIDED THAT AFTER DISCONNECTING THE ATTACHMENT FORM HAND PIECE, TWO METAL PINS FELL OUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18981045 ↗
• MalfunctionMar 8, 2024Excessive Heating; Excessive Heating

  ON 02/28/2024, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA (B)(4) THAT AN AR-400 DRILL SAW IS MAKING A VERY LOUD NOISE. THE HANDPIECE IS GETTING VERY HOT WHERE DOCTORS ARE NOT ABLE TO HAVE IT ON THEIR HANDS. THIS WAS DISCOVERED DURING A PROCEDURE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18869678 ↗
• MalfunctionJan 17, 2024Component Missing; Component Missing

  ON 12/21/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS (B)(4) THAT AN AR-400 DRILL SAW TOP BUTTON WAS MISSING PIN TO HOLD BUTTON IN PLACE. THIS WAS DISCOVERED DURING THE CASE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18526327 ↗
• MalfunctionDec 4, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ON 11/08/2023, IT WAS REPORTED BY A DISTRIBUTOR VIA SEMS-06394344 THAT AN AR-400 DRILL SAW ENGINE PARTS FELL OFF. THIS WAS DISCOVERED DURING USE IN A CASE WITH NO PATIENT EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18260070 ↗
• MalfunctionOct 27, 2023Crack; Crack

  ON 10/12/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS-06056491 THAT AN AR-400 DRILL SAW HOUSING IS CRACKED. THIS WAS DISCOVERED DURING A PROCEDURE. THE CASE WAS COMPLETED BY USING A NEW DEVICE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18024352 ↗
• MalfunctionSep 26, 2023Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT THE DRILL GETS VERY HOT DURING USE. THERE WAS NO HARM OR ADVERSE EVENT FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. NO FURTHER INFORMATION RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17816883 ↗
• MalfunctionJul 26, 2023Intermittent Loss of Power; Intermittent Loss of Power

  IT WAS REPORTED THAT DURING A FOOT SURGERY WHEN THE AR-400 RUNS, IT SUDDENLY LOOSES POWER, REGAINS POWER AND LOOSES POWER AGAIN. IT ALSO DOES NOT STOP ROTATING WHEN THE FORWARD OR REVERSE BUTTON IS PRESSED. 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 17395452 ↗
• InjuryJun 2, 2020Material Fragmentation; Device Damaged by Another Device

  IT WAS REPORTED DURING A FOOT PROCEDURE THE AR-400 DRILL WAS SHREDDING K-WIRE. THE K-WIRE WAS REPLACED BUT THE SAME EVENT OCCURRED. THE SHREDDING OF THE K-WIRE CAUSED DEBRIS INSIDE THE WOUND. THE DOCTOR REMOVED AS MUCH DEBRIS AS HE COULD. THE DRILL WAS REPLACED AND THE CASE WAS COMPLETED WITHOUT FURTHER ISSUES. AFTER A WEEK POSTOP THE PATIENT DEVELOPED AN INFECTION. FOLLOW UP DOS (B)(6): INFECTION WAS FOUND (B)(6) AND THERE ARE X-RAYS. AN AR-400PD (PIN DRIVE ATTACHMENT) WAS BEING USED WITH THE DRILL. ADDITIONAL INFORMATION OBTAINED 05/13/2020: THE PATIENT'S ORIGINAL PROCEDURE WAS A FRACTURE, OPEN, FOOT METATARSAL, LEFT. THE FACILITY HAS CONFIRMED THAT THERE WERE NO REMNANTS FROM THE DRILL ITSELF IN THE PATIENT. ONLY K-WIRE REMNANTS REMAINED IN THE PATIENT. THE SAME DRILL HAD BEEN USED IN PRIOR CASES BUT THE DRILL WAS TAKEN OUT OF SERVICE IMMEDIATELY FOLLOWING THIS INCIDENT. THE FACILITY REPORTER PROVIDED PART NUMBER INFORMATION FOR THE K-WIRE USED DURING THE PATIENT'S PROCEDURE. THE PART NUMBER INFO PROVIDED IS AS FOLLOWS: PART #1600-1654, LOT#0418323390 K-WIRE 1.4MM(0.054") X 152MM (6") THIS PART NUMBER IS ANOTHER MANUFACTURER'S PRODUCT (MICROAIRE). ADDITIONAL INFORMATION OBTAINED

  Patient problems: Device Embedded In Tissue or Plaque; Unspecified Infection

  MAUDE report 10108902 ↗