Arthrex® AR-41006Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00888867196339), received between Apr 20, 2021 and Feb 4, 2025 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Break” (7 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 4, 2025Break; Break

  ON 01/10/2025, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA (B)(4) THAT AN AR-41006 MEGABITERS CLAMP BROKE. THIS OCCURRED DURING A CASE WHEN THE CLAMP BROKE INSIDE THE JOINT. THERE WAS NO ADDITIONAL INFORMATION PROVIDED, AND ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21304093 ↗
• MalfunctionJan 6, 2025Break; Break

  ON 9TH DECEMBER 2024, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT AN AR-41006, MEGABITER¿, STRAIGHT TIP, 5.5 MM X 2.5 MM, WAS BROKEN. THIS WAS DETECTED DURING A PARTIAL RESECTION OF DEGENERATIVE TORN MENISCUS PROCEDURE ON (B)(6) 2024. THE CUTTER OF AR-41006 WAS BROKEN AND ALL THE FRAGMENTS WERE RETRIEVED FROM PATIENT. PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO PATIENT HARM AND NO SECONDARY PROCEDURE NEEDED, BY USING ANOTHER NEW AR-41006 INSTEAD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21078463 ↗
• MalfunctionJun 10, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY THE FORCEPS BROKE OFF WHEN THE DEVICE WAS PULLED OUT OF THE PATIENT'S KNEE JOINT. IT WAS FURTHER REPORTED THAT THE FORCEPS BROKE OUTSIDE THE JOINT AND IT WAS CONFIRMED WITH AN X-RAY THAT NOTHING WAS LEFT INSIDE THE PATIENT. ACCORDING TO THE SURGEON THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. NO FURTHER INFORMATION RECEIVED. 17-NOV-2022 UPDATE DW: FURTHER INFORMATION WERE PROVIDED THAT THE SURGERY COULD BE FINISHED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19499145 ↗
• MalfunctionMay 23, 2024Break; Break

  ON 04/25/2024, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA (B)(4) THAT AN AR-41006 MEGABITER TIP WAS BROKEN. THE CASE WAS COMPLETED USING ANOTHER AR-41006 MEGABITER. ALL FRAGMENTS WERE RETRIEVED. NO PATIENT EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19388581 ↗
• MalfunctionJul 5, 2022Break

  ON (B)(6) 2022, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA SEMS THAT AN AR-41006 MEGABITER HEAD BROKE DURING REMOVAL OF THE BOTTOM OF THE MENISCUS. THE PROCEDURE WAS COMPLETED USING ANOTHER MEGABITER WITHOUT FURTHER ISSUES. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2022.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14915425 ↗
• MalfunctionMay 18, 2021Break

  IT WAS REPORTED DURING A KNEE ARTHROSCOPY PROCEDURE THE TOP JAW OF THE BITER BROKE OFF. IT WAS RETRIEVED FROM THE PATIENT AND THE BITER WAS REPLACED. THE CASE WAS COMPLETED WITH NO FURTHER ISSUES AND THE PATIENT IS FINE TO DATE.

  Patient problems: Insufficient Information

  MAUDE report 11842441 ↗
• MalfunctionApr 20, 2021Break

  IT WAS REPORTED THAT THE JAW OF THE MEGABITER BROKE OFF DURING USE IN A MENISECTOMY. THE BROKEN PIECE FELL ON THE FLOOR. AN X-RAY WAS DONE TO CONFIRM NOTHING WENT INTO THE PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 11692526 ↗