Arthrex® AR-9835Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00888867320253), received between Aug 3, 2021 and Aug 31, 2026 — classified as 14 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. 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 31, 2026Sparking; Unexpected Shutdown

  On (b)(6) 2026, it was reported by a sales Representative via (b)(6) that an AR-9835 ablation probe started malfunctioning, showed a brief flash of bright light at the tip of the probe, turned some tissue black and then stopped working. Noticed during a case, device swapped, and case completed with no patient effect.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50524018 ↗
• MalfunctionJan 23, 2026Break

  ON 8-JAN-2026, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS-07182077 THAT AN AR-9835 ABLATION PROBE'S TIP BROKE OFF. NOTICED DURING A CASE, DEVICE SWAPPED, AND CASE COMPLETED WITH NO PATIENT EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24163375 ↗
• MalfunctionDec 17, 2025Break; Break

  IT WAS REPORTED THAT DURING A HIP ARTHROSCOPY A PART OF THE DEVICE BROKE OFF. THE BROKEN PIECE WAS RETRIEVED OUT OF 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 23828698 ↗
• MalfunctionAug 8, 2025Break; Overheating of Device; Break; Overheating of Device

  IT WAS REPORTED THAT DURING A HIP ARTHROSCOPY THE DEVICE OVERHEATED AND THE METAL PLATE IN THE MIDDLE BROKE. 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) 29-JUL-2025. FURTHER INFORMATION WAS RECEIVED THAT THE METAL BRIDGE BETWEEN THE TWO HOLES IN THE PROBE BURNED THROUGH, CAUSING THE PROBE TO LOSE FUNCTIONALITY, BUT NO PARTS BROKE OFF OR REMAINED IN THE JOINT.

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

  MAUDE report 22749042 ↗
• MalfunctionAug 8, 2025Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT DURING A HIP ARTHROSCOPY THE DEVICE OVERHEATED AND THE METAL PLATE IN THE MIDDLE BROKE. 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)(4) 29-JUL-2025 FURTHER INFORMATION WAS RECEIVED THAT THE METAL BRIDGE BETWEEN THE TWO HOLES IN THE PROBE BURNED THROUGH, CAUSING THE PROBE TO LOSE FUNCTIONALITY, BUT NO PARTS BROKE OFF OR REMAINED IN THE JOINT.

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

  MAUDE report 22748999 ↗
• MalfunctionAug 6, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A HIP ARTHROSCOPY A SMALL METAL PIECE OF THE PROBE HEAD HAS COME LOOSE IN THE JOINT. 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. UPDATE AVOE (B)(6) 2025. IT WAS CONFIRMED THAT THE FRAGMENT HAS NOT COMPLETELY DETACHED FROM THE PROBE. UPDATE AVOE (B)(6) 2025. A USER REPORT WAS PROVIDED BY THE AUTHORITY WITH THE FOLLOWING INFORMATION REGARDING THE FAILURE: DURING A HIP JOINT ARTHROSCOPY, THE APPROX. 4 MM LARGE HF HEAD DETACHED FROM THE STEM OF THE DEVICE WITHOUT ANY UNUSUAL MECHANICAL STRESS. THIS OCCURRED INTRA-ARTICULARLY. THE FRAGMENT COULD BE REMOVED WITHOUT CAUSING ANY RECOGNIZABLE DAMAGE TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22727277 ↗
• MalfunctionMay 6, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ON 04/22/2025, A FACILITY REPRESENTATIVE REPORTED VIA (B)(4) THAT AN AR-9835 ASPIRATING ABLATOR PROBE TIP DETACHED INSIDE THE JOINT DURING A HIP SCOPE. NO PATIENT WAS AFFECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21967325 ↗
• MalfunctionMay 1, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A HIP SURGERY THE TIP OF THE DEVICE SIMPLY FELL OFF. 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 21941201 ↗
• MalfunctionDec 30, 2024Break; Break

  IT WAS REPORTED THAT DURING A HIP ASK SURGERY AT THE PROBE A PIECE OF THE BLACK ISOLATION DID COME LOOSE. 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 21036346 ↗
• MalfunctionDec 12, 2024Unexpected Shutdown; Unexpected Shutdown

  IT WAS REPORTED THAT DURING A HIP ARTHROSCOPY WITH LABRUM SUTURE THE PROBE STOPPED WORKING. THE SUCTION WAS NOT WORKING ANYMORE AND THE DEVICE HAS LOST ITS POWER. 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 20913646 ↗
• MalfunctionDec 11, 2024Break; Break

  IT WAS REPORTED THAT DURING A HAS SURGERY THE PLATE AT THE TIP DID FALL APART. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVIE 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 20906483 ↗
• MalfunctionMar 28, 2022Loose or Intermittent Connection

  IT WAS REPORTED THAT DURING A HIP ARTHROSCOPY THE DEVICE HAD A LOOSE CONTACT. NO PART OF THE DEVICE BROKE OFF. 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. DURING RETURNED DEVICE EVALUATION, A REPORTABLE MALFUNCTION WAS DISCOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13927693 ↗
• MalfunctionNov 22, 2021Unexpected Shutdown

  IT WAS REPORTED THAT DURING A SHOULDER SURGERY THE ABLATOR FUNCTIONED JUST A SHORT TIME AND THEN IT STOPPED WORKING. 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. DURING RETURNED DEVICE EVALUATION, A REPORTABLE MALFUNCTION WAS DISCOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12853196 ↗
• MalfunctionAug 3, 2021Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT REVISION SURGERY AFTER THREE MINUTES THE FRONT PLATE OF THE DEVICE CAME OFF. THE DEVICE BROKE INSIDE THE PATIENT AND THE BROKEN PART DIDN`T REMAIN 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12268443 ↗