Arthrex® AR-11210Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00888867002968), received between Mar 2, 2021 and May 13, 2024 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Component Missing” (2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 13, 2024Break; Break

  ON 04/17/2024, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA SEMS-06541976 THAT AN AR-11210 LARGE PUNCH LEFT A PIECE OF METAL IN THE PATIENT. THIS OCCURRED DURING A PROCEDURE WHERE THE METAL WAS TAKEN OUT, AND THE PATIENT WAS OKAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19297522 ↗
• MalfunctionApr 13, 2021Component Missing; Dull, Blunt; Difficult to Open or Close

  THIS IS A CONVERSION FROM CC183280, LINE 281969. AN CUSTOMER UPDATE WAS RECEIVED WHICH MADE A REPAIR TO A COMPLAINT. THE CUSTOMER STATED THE INSTRUMENT DOES NOT CLOSE CORRECTLY AND IS BLUNT. NO ADDITIONAL INFORMATION AS TO WHAT FAILURE MODE OCCURRED WAS PROVIDED. THERE WAS NO HARM OR ADVERSE EVENT FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED BY THE CUSTOMER. UPDATE 08-APR-2021: FURTHER INFORMATION WERE PROVIDED THAT INTRA-OPERATIVELY IT WAS FOUND THAT THE INSTRUMENT DID NOT GRIP. THE INSTRUMENT WAS REMOVED FROM THE OPERATING AREA, CLEANED AND SENT FOR REPAIR. THE CUSTOMER REPORTED THAT THE MISSING PIN WAS NOT NOTICED EITHER IN THE OPERATING DEPARTMENT OR IN THE STERILIZATION DEPARTMENT. THIS IS NOW REPORTABLE. DURING RETURNED DEVICE EVALUATION, A REPORTABLE MALFUNCTION WAS DISCOVERED. DEVICE HAS A MISSING TIP PIN. THE PRECISE CAUSE FOR A MISSING TIP PIN COULD NOT BE DETERMINED. TIP PIN WAS NOT RETURNED OR ACCOUNTED FOR DURING EVALUATION/INVESTIGATION PROCESS. FUNCTION TEST COULD NOT BE PERFORMED DUE TO THE RELATED CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11655796 ↗
• MalfunctionMar 2, 2021Component Missing; Difficult to Open or Close

  IT WAS REPORTED, THAT DURING KNEE PROCEDURE JAW ON THE AR-11210, WOULD NOT OPEN. THE CASE WAS COMPLETES USING A DIFFERENT PUNCH. ADDITIONAL INFORMATION 2/10/2021 PER THE SALES REP- AR-11210 / BATCH 82412 ¿ DEVICE HAS A MISSING TIP PIN ON THE DISTAL END OF THE TIP (UNDETERMINED). ADDITIONAL INFORMATION 2/11/2021 PER THE SALES REP THE PIN CAME OFF AFTER WE REMOVED THE INSTRUMENT FROM THE KNEE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11398295 ↗