Arthrex® AR-1204FDSRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888867004610), received between Oct 4, 2021 and Oct 4, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 4, 2021Break; Detachment of Device or Device Component

  ON (B)(6) 2021 IT WAS REPORTED BY A SALE REPRESENTATIVE VIA SEMS THAT AN AR-1204FDS DRILL SLEEVE, HAS FALLEN APART. THIS WAS DISCOVERED DURING A PROCEDURE, NO PATIENT AFFECT REPORTED. THERE WAS NO ADDITIONAL INFORMATION PROVIDED. ADDITIONAL INFORMATION 9/23/2021 ON (B)(6) 2021 IT WAS REPORTED BY A SALE REPRESENTATIVE VIA EMAIL THAT AN AR-1204FDS DRILL SLEEVE, SEAL BROKE BETWEEN THE DRILL SLEEVE AND THE ROUND SHOULDER OF THE SLEEVE. THIS WAS DISCOVERED DURING USE IN A MENISCAL ROOT REPAIR PROCEDURE, ON (B)(6) 2021. THE SURGEON WAS ABLE TO COMPLETE THE CASE BY USING THE DRILL SLEEVE WITHOUT THE ROUND SHOULDER THAT CAME APART FROM THE INSTRUMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12569541 ↗