Arthrex® AR-2664LRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888867098404), received between Oct 4, 2022 and Mar 11, 2024 — classified as 2 malfunctions.

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

• MalfunctionMar 11, 2024Break; Break

  IT WAS REPORTED THAT DURING A SURGERY THE FIXING SCREW BROKE DURING DRILLING. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. NO FURTHER INFORMATION RECEIVED. UPDATE AVOE 26-FEB-2024. FURTHER INFORMATION WAS PROVIDED THAT THE DEVICE FAILURE OCCURRED DURING AN OPEN REDUCTION INTERNAL FIXATION (ORIF) SURGERY AND ALL FRAGMENTS 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 18876296 ↗
• MalfunctionOct 4, 2022Break; Mechanical Jam

  IT WAS REPORTED ON 08/05/2022 BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-2664L SCREW THAT ADHERES TO THE DRILL GUIDE BROKE IN HALF. THIS WAS DISCOVERED DURING A CASE WITH NO PATIENT HARM. ADDITIONALLY, AN AR-2658TR TIGHTROPE BECAME STUCK AND THE INSERTER WOULD NOT RELEASE. THIS WAS DISCOVERED DURING A CASE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15538191 ↗