Arthrex® AR-10010Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 00888867002364), received between Dec 20, 2018 and Sep 29, 2026 — classified as 2 injuries, 19 malfunctions.

The most frequently reported specific device problem is “Break” (15 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50931563 ↗
• InjuryApr 28, 2026Break

  IT WAS REPORTED THAT DURING THE KNEE ARTHROSCOPY, A PART OF THE INSTRUMENT BROKE OFF INSIDE THE PATIENT'S KNEE JOINT. THE BROKEN PIECE WAS REMOVED FROM THE PATIENT THROUGH AN ADDITIONAL INCISION. 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 25021159 ↗
• MalfunctionDec 4, 2025Break; Break

  IT WAS REPORTED DURING THE SHOULDER ARTHROSCOPY THAT THE TIP OF THE INSTRUMENT HAD BROKEN OFF. 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 23714752 ↗
• MalfunctionDec 5, 2024Break; Break

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY THE DEVICE WAS VERY THIN AT THE FRONT AND THEREFORE GOT BENT DURING THE PROCEDURE. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH THE SAME DEVICES. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20857909 ↗
• MalfunctionDec 5, 2024Break; Break

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY THE DEVICE WAS VERY THIN AT THE FRONT AND THEREFORE GOT BENT DURING THE PROCEDURE. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH THE SAME DEVICES. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20855234 ↗
• MalfunctionDec 5, 2024Break; Break

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY THE DEVICE WAS VERY THIN AT THE FRONT AND THEREFORE GOT BENT DURING THE PROCEDURE. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH THE SAME DEVICES. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20855071 ↗
• MalfunctionNov 8, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY THE TIP OF THE PROBE BECAME BENT AT THE SLIGHTEST RESISTANCE. 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 20641453 ↗
• MalfunctionSep 6, 2024Break; Break

  ON (B)(6) 2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-10010 PROBE BROKE. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT. A NEW PROBE WAS USED TO COMPLETE THE CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20162843 ↗
• MalfunctionJun 19, 2024Pitted; Pitted

  IT WAS REPORTED THAT THERE IS PITTING CORROSION WITH THIS DEVICE. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD-PARTY REPORTED. NO FURTHER INFORMATION RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19567649 ↗
• MalfunctionJun 6, 2024Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  IT WAS REPORTED ON 05/31/2022 BY A FACILITY REPRESENTATIVE VIA SEMS THAT AN AR-10010 PROBE HOOK WAS BENDING. THIS WAS DISCOVERED DURING A CASE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19478431 ↗
• MalfunctionMay 20, 2024Break; Break

  IT WAS REPORTED THAT THE DEVICE IS BENT. THERE WAS NO HARM FOR THE PATIENT, OPERATOR OR THIRD PARTY REPORTED. NO FURTHER INFORMATION RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19352639 ↗
• MalfunctionMay 8, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A KNEE SURGERY THE TIP OF THE DEVICE BENT. NO PART OF THE DEVICE BROKE OFF. THERE WAS NO HARM OR ADVERSE EVENT FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. 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 19265919 ↗
• MalfunctionMay 2, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY SURGERY THE DEVICE DID NOT ACTION AND WAS NOT WORKING. ACCORDING TO THE SURGEON NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY OCCURRED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH THE SAME DEVICE. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY. ***UPDATE AVOE 15-APR-2024. IT WAS CONFIRMED THAT THE TIP OF THE TOOL BROKE OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19234912 ↗
• MalfunctionApr 30, 2024Break; Break

  IT WAS REPORTED THAT THE DEVICE IS BENT. 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 19211978 ↗
• MalfunctionApr 25, 2024Defective Device; Defective Device

  IT WAS REPORTED THAT THE DEVICE IS DEFECTIVE, THE TIP OF THE HOOK IS BENT. 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 19183607 ↗
• MalfunctionFeb 15, 2024Corroded; Corroded

  ON 11/22/2023, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA (B)(4) THAT DURING A RCR PROCEDURE, WHEN THE SURGEON WAS USING A HOOK PROBE, AR-10010, AND IT WAS FOUND TO BE RUSTY. THE PROBE WAS REPLACED WITH A DEVICE FROM ANOTHER MANUFACTURER AND THE CASE WAS COMPLETED WITH NO ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18711037 ↗
• MalfunctionSep 12, 2022Break

  IT WAS REPORTED THAT THE DEVICE BROKE. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. NO FURTHER INFORMATION RECEIVED. UPDATE 30-AUG-2022. IT WAS CONFIRMED THAT THE DEVICE BROKE DURING A SURGERY ON THE (B)(6) 2022. ALL BROKEN PARTS WERE RETRIEVED FROM THE PATIENT. ACCORDING TO THE SURGEON NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY OCCURRED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A DIFFERENT 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 15401862 ↗
• MalfunctionDec 13, 2021Break; Entrapment of Device

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC CARTILAGE SMOOTHING AT THE KNEE JOINT THE DISTAL END OF THE DEVICE BROKE OFF. THE TIP OF THE DEVICE COULD NOT BE RETRIEVED OUT OF THE PATIENT. NO INFORMATION PROVIDED BY THE CUSTOMER. 25-NOV-2021 UPDATE: FURTHER INFORMATION WAS PROVIDED THAT THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 12983419 ↗
• MalfunctionNov 16, 2021Break

  ON 10/26/2021 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-10010 BROKE OFF IN THE PATIENT DURING SURGERY. NO PATIENT AFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12819169 ↗
• MalfunctionJun 21, 2021Break

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR AN AR-10010 PROBE HOOK, BROKE DURING THE PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12032282 ↗
• InjuryDec 20, 2018Break

  IT WAS REPORTED THAT DURING A KNEE SCOPE, THE PROBE TIP BROKE WHEN IN USE IN THE MENISCUS. AN ADDITIONAL INCISION WAS REQUIRED TO RETRIEVE IT FROM THE MEDIAL SIDE. A C-ARM WAS USED TO CONFIRM ALL WAS REMOVED AND THE CASE WAS COMPLETED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8184857 ↗