Arthrex® AR-8400TDRecalls & reported problems

Summary

The FDA's MAUDE database contains 86 adverse event reports that list this exact device (DI 00888867043657), received between Mar 1, 2017 and Sep 28, 2026 — classified as 7 injuries, 79 malfunctions.

The most frequently reported specific device problem is “Break” (61 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 86 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2026Material Fragmentation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50923781 ↗
• MalfunctionApr 9, 2026Break

  ON 17-MAR-2026, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA (B)(4) THAT AN AR-8400TD TORPEDO BROKE INSIDE THE SHOULDER JOINT. THIS WAS DISCOVERED DURING A PROCEDURE WITH NO PATIENT HARM REPORTED. THE SURGICAL TEAM WAS ABLE TO RETRIEVE SOME OF THE FRAGMENTS BUT COULD NOT LOCATE EVERY PIECE. AN INTRAOPERATIVE X-RAY WAS TAKEN TO CONFIRM THAT NO FRAGMENTS REMAINED INSIDE THE JOINT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24829553 ↗
• MalfunctionApr 8, 2026Material Fragmentation; Overheating of Device

  IT WAS REPORTED THAT DURING THE KNEE ARTHROSCOPY, THE DEVICE GOT HOT AT THE CONNECTOR, AND SHORTLY AFTERWARD, A CLICKING SOUND WAS HEARD, CAUSING NUMEROUS SMALL METAL FRAGMENTS TO ENTER THE PATIENT. AN ATTEMPT WAS MADE TO COMPLETELY REMOVE THE METAL DEBRIS, BUT IT CANNOT BE DEFINITIVELY RULED OUT THAT SOME METAL DEBRIS REMAINS IN 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: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24814963 ↗
• MalfunctionMar 26, 2026Device Damaged by Another Device

  ON 20-MAR-2026, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA (B)(4) THAT AN AR-8400TD TORPEDO WAS DAMAGED DURING USE. WHILE USING THE AR-8400TD TORPEDO ON THE POSTERIOR HORN OF THE LATERAL MENISCUS AND PERFORMING THE NECESSARY RESHAPING, A LOOSE MENISCAL SUTURE WAS OBSERVED WHICH THE SPECIALIST REMOVED WITH THE TORPEDO. AT WHICH POINT, IT BE CAME EVIDENT THAT THE INNER BLADE WAS NO LONGER ROTATING. THE DEVICE WAS THEN INSPECTED AND IT WAS FOUND THE INNER BLADE WAS SLIGHTLY BENT. THIS WAS DISCOVERED DURING A KNEE CHONDROPLASTY PROCEDURE WITH NO PATIENT HARM. NO ADDITIONAL ANESTHESIA WAS ADMINISTERED AND THE CASE WAS COMPLETED WITH ANOTHER DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24703168 ↗
• MalfunctionJan 26, 2026Break

  ON (B)(6)2026, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT AR-8400TD LOT/SERIAL (B)(6) TORPEDO BROKE WHILE IN USE ON (B)(6) 2026.

  Patient problems: Insufficient Information

  MAUDE report 24179835 ↗
• InjuryDec 31, 2025Break; Break

  ON 10-DEC-2025, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA (B)(4) THAT AN AR-8400TD TORPEDO, WHEN ACTIVATED INSIDE THE JOINT, MADE A STRANGE NOISE. IT WAS REMOVED FROM THE JOINT, INSPECTED, AND NOTED THAT THE TIP OF THE BLADE WAS BROKEN, WHICH REMAINS INSIDE THE BLADE. THIS WAS DISCOVERED DURING AN ACL PROCEDURE WITH NO PATIENT HARM. THE CASE WAS COMPLETED SUCCESSFULLY WITH ANOTHER DEVICE. ADDITIONAL INFORMATION PROVIDED ON 16-DEC-2025: IT WAS FURTHER REPORTED THAT AT THE END OF THE SURGERY, AN X-RAY WAS TAKEN TO CHECK THE POSITION OF THE CRUCIATE BUTTON, AND IT WAS NOTED THAT ONE OF THE BLADE FRAGMENTS REMAINED INSIDE THE JOINT. IT WAS ALSO INDICATED THAT THERE WAS A 20¿30-MINUTE DELAY AS THEY HAD TO GO BACK INTO THE JOINT TO TRY TO REMOVE THE FRAGMENT, ALTHOUGH IT COULD NOT BE REMOVED. NO ADDITIONAL ANESTHESIA WAS ADMINISTERED.

  Patient problems: Foreign Body In Patient

  MAUDE report 23936015 ↗
• MalfunctionDec 31, 2025Material Deformation; Noise, Audible; Material Deformation; Noise, Audible

  ON 11TH DEC 2025, IT WAS REPORTED BY AN ARTHREX'S EMPLOYEE VIA AN EMAIL THAT FOR 1 UNIT OF AR-8400TD, TORPEDO, 4.0 MM X 13 CM, AN ABNORMAL NOISE WAS DETECTED WHEN THE INNER CORE WAS ROTATING. WHEN THE INNER CORE WAS PULLED OUT, IT WAS FOUND TO BE DEFORMED. THIS WAS DETECTED DURING A KNEE JOINT DEBRIDEMENT SURGERY ON (B)(6) 2025. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY USING ANOTHER NEW AR-8400TD. THERE WERE NO PATIENT HARM AND NO SECONDARY PROCEDURE NEEDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23935174 ↗
• MalfunctionDec 9, 2025Break; Break

  ON (B)(6) 2025, A SALES REPRESENTATIVE REPORTED VIA PHONE THAT AN AR-8400TD TORPEDO DEVICE BROKE DURING A SHOULDER ARTHROSCOPY PROCEDURE. THE INNER BLADE TIP FRACTURED WITHIN THE DEVICE DURING USE. AN X-RAY WAS PERFORMED TO CONFIRM THAT NO FRAGMENTS REMAINED IN THE PATIENT. ALL FRAGMENTS WERE ACCOUNTED FOR. THE EVENT RESULTED IN AN APPROXIMATELY 35-MINUTE DELAY, REQUIRING ADDITIONAL ANESTHESIA. THE PROCEDURE WAS COMPLETED USING ANOTHER AR-8400TD TORPEDO, AND NO HARM OR ADVERSE EFFECTS TO THE PATIENT WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23760135 ↗
• MalfunctionDec 9, 2025Break; Break

  ON 11/20/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-8400TD TORPEDO HAD THE INNER PART OF THE SHAVER, WHEN IT CAME IN CONTACT WITH THE SUTURE, BROKE OFF. THIS WAS DISCOVERED DURING THE CASE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23757686 ↗
• MalfunctionDec 2, 2025Material Fragmentation; Material Fragmentation

  ON 11/10/2025, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA (B)(4) THAT AN AR-8400TD TORPEDO WAS PRODUCING DEBRIS. THIS HAPPENED AT LEAST FOUR TIMES DURING A KNEE ARTHROSCOPY PROCEDURE WITH NO PATIENT HARM. THE DOCTOR USED TWEEZERS AND THE SUCTION OF THE SHAVER TO REMOVE THE PARTICULATES. THE DOCTOR DECIDED TO NOT CONTINUE USING THE DEVICE AFTER REMOVING THE PARTICULATES AND THE CASE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23697156 ↗
• MalfunctionDec 2, 2025Break; Break

  ON 11/11/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-8400TD TORPEDO ENCOUNTERED AN OLD STITCH FROM A PRIOR REPAIR AND A PIECE OF METAL FROM THE INNER SHAVER BLADE BROKE OFF. THE PIECE OF METAL GOT LODGED IN THE SHAVER AND WAS RECOVERED. THIS WAS DISCOVERED DURING A MENISCAL DEBRIDEMENT CASE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE WITH NO PATIENT HARM. ADDITIONAL INFORMATION WAS REPORTED BY THE REP ON 11/17/25. THERE WAS NO OUTFLOW TUBING USED IN THE CASE. IRRIGATION FLOW WAS NORMAL WITHOUT INTERRUPTION DURING THE CASE. AS A RESULT OF THE SHAVER BLADE TIP BREAKING AND LODGING INTO THE SHAVER, THE HANDPIECE WAS DAMAGED. A NEW SHAVER HAND PIECE AND SHAVER BLADE WERE USED TO COMPLETE THE CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23692871 ↗
• MalfunctionNov 24, 2025Break; Break

  ON (B)(6) 2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-8400TD TORPEDO BROKE IN SOFT TISSUE. THIS WAS DISCOVERED DURING THE CASE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23632561 ↗
• MalfunctionOct 27, 2025Break; Break

  ON 23RD OCT 2025, IT WAS REPORTED BY AN ARTHREX'S EMPLOYEE VIA AN EMAIL THAT FOR 1 UNIT OF AR-8400TD, TORPEDO, 4.0 MM X 13 CM, THE SHAVER BLADE BROKE WHEN RETRIEVING IT. ALL FRAGMENTS WERE RETRIEVED FROM THE PATIENT. THIS WAS DETECTED DURING AN ACL RECONSTRUCTION SURGERY ON (B)(6) 2025. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY USING A NEW AR-8400TD. THERE WERE NO PATIENT HARM AND NO SECONDARY PROCEDURE NEEDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23390776 ↗
• MalfunctionOct 21, 2025Break; Break

  ON 10/10/2025, AN ARTHREX SUBSIDIARY EMPLOYEE REPORTED VIA (B)(4) THAT AN AR-8400TD 4 MM X 13CM TORPEDO BROKE WITHIN A PATIENT DURING A KNEE ARTHROSCOPY + ACL PROCEDURE. THE BROKEN PIECE WAS RETRIEVED FROM THE PATIENT, AND ANOTHER DEVICE COMPLETED THE PROCEDURE SUCCESSFULLY. NO PATIENT WAS AFFECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23350906 ↗
• MalfunctionOct 15, 2025Break; Break

  ON 10/08/2025, A FACILITY REPRESENTATIVE REPORTED VIA (B)(4) THAT AN AR-8400TD 4 MM X 13CM TORPEDO BROKE WITHIN A PATIENT DURING A SHOULDER ARTHROSCOPY. THE BROKEN PIECE WAS RETRIEVED FROM THE PATIENT, AND THE PROCEDURE WAS COMPLETED WITH NO PATIENT AFFECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23302448 ↗
• MalfunctionSep 3, 2025Break; Break

  IT WAS REPORTED THAT DURING A MENISCUS RESECTION SURGERY THE SHAVER BLADE BROKE AT THE BASE OF THE SHAVER. NO FRAGMENTS REMAINED 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 22951837 ↗
• MalfunctionAug 7, 2025Break; Break

  ON 7/30/2025, AN FDA MEDWATCH NOTIFICATION WAS RECEIVED VIA EMAIL. A FACILITY REPRESENTATIVE REPORTED THAT THE ATTACHMENT PIECE OF AN AR-8400TD TORPEDO SHAVER BROKE OFF DURING USE. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2025.

  Patient problems: Insufficient Information

  MAUDE report 22742260 ↗
• MalfunctionAug 1, 2025Break; Break

  ON 07/11/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-8400 TD HAD HALF OF THE INNER BLADE BRAKE OFF IN A PATIENT'S SHOULDER JOINT DURING AN ARTHROSCOPY. THIS WAS DISCOVERED DURING A CASE WITH NO PATIENT HARM.

  Patient problems: Insufficient Information

  MAUDE report 22686786 ↗
• MalfunctionJun 30, 2025Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT DURING A MENISCUS SURGERY, THE BLADE OF THE DEVICE RUBBED ON THE STEM WHEN CLEANING THE MENISCUS AND THERE WAS A RISK THAT IT WOULD COME OFF IF THE SURGEON CONTINUED. 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 22358948 ↗
• MalfunctionJun 23, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A MENISCUS SURGERY, THE BLADE OF THE DEVICE RUBBED ON THE STEM WHEN CLEANING THE MENISCUS AND THERE WAS A RISK THAT IT WOULD COME OFF IF THE SURGEON CONTINUED. 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 CMACKENBACH 6-JUN-2025 FURTHER INFORMATION WAS RECEIVED THAT NOTHING BROKE OFF INSIDE THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22311202 ↗
• MalfunctionMay 1, 2025Break; Break

  ON 17TH APRIL 2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT FOR AN AR-8400TD TORPEDO, 4.0MM X 13CM, THE TIP OF THE TORPEDO SHAVER BROKE OFF. THIS WAS DETECTED DURING USE IN A KNEE ARTHROSCOPY ON (B)(6) 2025. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AS PER NORMAL PROCEDURE. THE SCRUB NURSE REPORTED SEEING IT IN THE PATIENT BUT SAID SHE IS SURE IT WAS REMOVED. THE SURGEON REPORTED THAT THE SHAVER MADE AN UNUSUAL NOISE AND THEN AFTER THIS THE BREAKAGE OCCURRED. THE ITEM HAS BEEN SAVED, CLEANED AND WILL BE AVAILABLE FOR RETURN. THIS IS THE SECOND TIME THIS HAS HAPPENED TO THIS SURGEON.

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

  MAUDE report 21941532 ↗
• MalfunctionMar 21, 2025Break; Break

  ON 03/07/2025, A SALES REPRESENTATIVE REPORTED VIA (B)(4) THAT AN AR-8330H SHAVER HP HAD A PIECE OF A BROKEN TIP OF AN AR-8400TD TORPEDO THAT COULD HAVE BROKEN OFF AND FALLEN INSIDE. THE ISSUE WAS DISCOVERED DURING THE SURGERY. ANOTHER DEVICE WAS SWAPPED, AND THE CASE WAS COMPLETED WITHOUT ADVERSE EFFECTS ON THE PATIENT. X-RAYS WERE TAKEN, AND THERE WERE NO PIECES OF THE BROKEN DEVICE INSIDE THE PATIENT. THIS WAS DISCOVERED DURING A PROCEDURE, WITH NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21664021 ↗
• MalfunctionFeb 24, 2025Break; Break

  ON 18 FEBRUARY 2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-8400TD TORPEDO, 4.0MM X 13CM WAS REPORTED TO HAVE THE TIP MISSING IMMEDIATELY AFTER USE. THIS OCCURRED ON (B)(6) 2025 IN ROYSTON DAY SURGERY DURING A KNEE ARTHROSCOPY. IT WAS REPORTED THE TORPEDO WAS IN USE DURING A ROUTINE PROCEDURE AND IT WAS NOTICED THE TIP OF THE INNER BLADE WAS MISSING AND POTENTIALLY RETAINED WITHIN THE PATIENT OR SUCTIONED AWAY. JUST PRIOR TO NOTICING THE MISSING TIP, THE TORPEDO WAS MAKING AN UNUSUAL NOISE. THE STAFF CANNOT SAY FOR CERTAIN WHETHER THE TIP WAS PRESENT AT THE START OF THE PROCEDURE BEFORE USE, OR NOT. NO X-RAY WAS TAKEN. NO FURTHER DETAILS ARE AVAILABLE AT THIS TIME. NO LOT OR BATCH NUMBER IS AVAILABLE AND THE ITEM HAS NOT BEEN KEPT OR PHOTOGRAPHED. THE CASE WAS COMPLETED SUCCESSFULLY USING THE SAME DEVICE. THERE WAS CASE INVOLVEMENT.

  Patient problems: Insufficient Information

  MAUDE report 21444542 ↗
• MalfunctionFeb 6, 2025Break; Break

  ON 17TH JANUARY 2025, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT AN AR-8400TD, TORPEDO, 4.0 MM X 13 CM SHAVER BLADE HAD A BROKEN TIP. THIS WAS DETECTED DURING A BANKART REPAIR AND REPASSAGE PROCEDURE ON (B)(6) 2025. THE TORPEDO SHAVER WAS USED IN NORMAL FASHION TO DEBRIDE REMNANT SUTURE. SHAVER FRAGMENT WAS VISUALLY DISPLACED ON ARTHROSCOPIC VIEW. ON REMOVAL, THE TIP WAS FOUND TO BE BROKEN. ALL FRAGMENTS WERE CONTAINED WITHIN THE TIP. PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO PATIENT HARM BY USING AR-8400EX. INTRA-OP X-RAY SHOWED NO FRAGMENTS REMAINED IN PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21323532 ↗
• MalfunctionJan 22, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING A SURGERY THE DEVICE WAS DEFECTIVE. THE BLADE WAS STUCK IN THE JOINT. ALL PARTS COULD BE REMOVED. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. NO FURTHER INFORMATION WAS PROVIDED. FURTHER INFORMATION WAS PROVIDED ON (B)(6) 2025 THAT AN ACL SURGERY WAS PERFORMED. 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 21209608 ↗