Arthrex® AR-41026Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00888867032743), received between Apr 20, 2021 and Apr 25, 2024 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Break” (12 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 25, 2024Break; Break

  IT WAS REPORTED THAT THE MOVABLE FRONT PART OF THE DEVICE BROKE OFF. THERE WAS NO HARM OR ADVERSE EVENT FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. NO FURTHER INFORMATION RECEIVED. UPDATE AVOE 09-JUN-2021: IT WAS CONFIRMED THAT THE DEVICE BROKE DURING A SURGERY WHEN PULLING THE DEVICE OUT OF THE KNEE. THE DEVICE WAS REMOVED FROM THE KNEE AND WHEN THE SURGEON OPENED THE JAW OF THE DEVICE THE MOVABLE FRONT PART OF THE DEVICE BROKE OFF. THE BREAKAGE OCCURRED OUTSIDE OF THE PATIENT AND THEREFORE NO BROKEN PARTS HAD TO BE REMOVED FROM THE PATIENT. THERE WAS NO HARM OR ADVERSE EVENT FOR PATIENT, OPERATOR OR THIRD PARTY 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19187796 ↗
• MalfunctionJun 8, 2023Break; Break

  IT WAS REPORTED THAT DURING A MENISCAL RESECTION SURGERY THE TIP 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17086013 ↗
• MalfunctionOct 31, 2022Break

  THIS IS A CONVERSION FROM (B)(4), LINE 295519. A CUSTOMER UPDATE WAS RECEIVED WHICH MADE A REPAIR TO A COMPLAINT. THE CUSTOMER STATED DURING THE RESECTION OF THE MENISCUS THE JAW BROKE. THE PROBLEM WAS NOTICED DURING THE SURGERY. THE SURGERY WAS COMPLETED SUCCESSFULLY. A PART BROKE OFF INSIDE THE PATIENT BUT THE BROKEN OFF PART COULD BE RETRIEVED. TO FINISH THE SURGERY SUCCESSFULLY, A NEW DEVICE WITH THE SAME PART NUMBER WAS USED. THERE WAS NO NEED TO SWITCH TO ANOTHER SURGICAL TECHNIQUE AND NO SECOND SURGERY WAS NECESSARY. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15698328 ↗
• MalfunctionMay 9, 2022Break

  IT WAS REPORTED THAT THE JAW IN THE FRONT IS BROKEN OFF. THE PROBLEM WAS NOTICED DURING REPROCESSING. NO FURTHER INFORMATION RECEIVED. (B)(6) 2022 UPDATE: FURTHER INFORMATION WERE PROVIDED THAT THE REPORTED EVENT OCCURRED DURING A SURGERY. THE PARTS DID NOT REMAIN IN THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14336103 ↗
• MalfunctionMay 9, 2022Break

  IT WAS REPORTED THAT THE JAW IN THE FRONT IS BROKEN OFF. THE PROBLEM WAS NOTICED DURING REPROCESSING. NO FURTHER INFORMATION RECEIVED. 20-APR-2022 UPDATE: FURTHER INFORMATION WERE PROVIDED THAT THE REPORTED EVENT OCCURRED DURING A SURGERY. THE PARTS DID NOT REMAIN IN THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14336090 ↗
• MalfunctionMay 9, 2022Break

  IT WAS REPORTED THAT THE JAW IN THE FRONT IS BROKEN OFF. THE PROBLEM WAS NOTICED DURING REPROCESSING. NO FURTHER INFORMATION RECEIVED. 20-APR-2022 UPDATE: FURTHER INFORMATION WERE PROVIDED THAT THE REPORTED EVENT OCCURRED DURING A SURGERY. THE PARTS DID NOT REMAIN IN THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14336089 ↗
• MalfunctionFeb 28, 2022Break

  ON 02/07/2022, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA SEMS THAT AN AR-41026 MEGABITER IS BROKEN. THIS WAS DISCOVERED DURING USE WITH NO IMPACT TO THE PATIENT. ADDITIONAL INFORMATION REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13620384 ↗
• MalfunctionFeb 14, 2022Break

  IT WAS REPORTED THAT DURING A SURGERY A PART OF THE DEVICE BROKE INSIDE THE PATIENT. ALL FRAGMENTS WERE RETRIEVED FROM THE PATIENT. NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY WAS REPORTED. NO FURTHER INFORMATION RECEIVED.

  Patient problems: Insufficient Information

  MAUDE report 13528661 ↗
• MalfunctionFeb 14, 2022Break

  IT WAS REPORTED THAT DURING A SURGERY THE TIP OF THE DEVICE BROKE INSIDE THE PATIENT. ALL FRAGMENTS WERE RETRIEVED FROM THE PATIENT. NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY WAS REPORTED. NO FURTHER INFORMATION RECEIVED.

  Patient problems: Foreign Body In Patient

  MAUDE report 13528605 ↗
• MalfunctionDec 21, 2021Break; Loose or Intermittent Connection

  IT WAS REPORTED THAT DURING A ROTATOR CUFF SHOULDER ARTHROSCOPY SURGERY THE DEVICE BROKE, AND THE UPPER JAW WAS LOOSE IN THE JOINT. THE SURGEON WAS ABLE TO RETRIEVE THE JAW, AND THERE WHERE NO ADDITIONAL LOOSE BODIES IN THE JOINT. 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: Failure of Implant

  MAUDE report 13054392 ↗
• MalfunctionApr 20, 2021Break

  IT WAS REPORTED THAT DURING A MENISCAL RESECTION THE TIP OFF THE ITEM BROKE OFF INSIDE THE PATIENT. THE BROKEN PIECE WAS RETRIEVED FROM PATIENT. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11692397 ↗
• MalfunctionApr 20, 2021Break

  IT WAS REPORTED THAT THE TIP OF THE ITEM BROKE OFF INSIDE THE PATIENT DURING MENISCAL RESECTION SURGERY. THE BROKEN PIECE WAS RETRIEVED FROM PATIENT. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11692394 ↗