Arthrex® AR-601-TIB0Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888867037847), received between Sep 26, 2023 and Sep 26, 2023 — 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.

• MalfunctionSep 26, 2023Break; Break

  ON 8/28/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS-06016486 THAT AN AR-601-TIB0 IBALANCE UKA, TIBIAL IMPACTOR BODY ASSEMBLY, AND AN AR-601-TIH0 IBALANCE UKA, TIBIAL IMPACTOR HEAD BROKE IN A CASE. THERE WAS NO ISSUE WITH THE PATIENT. THIS OCCURRED DURING USE IN AN UNSPECIFIED PROCEDURE ON (B)(6) 2023 WITH NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED. ON 9/15/2023, THE SALES REPRESENTATIVE PROVIDED THE FOLLOWING INFORMATION VIA EMAIL: THIS OCCURRED DURING A REVERSE PROCEDURE, IT WAS NOT A REVISION SURGERY. THE DEVICES BROKE INSIDE THE PATIENT, AND ALL FRAGMENTS WERE RETRIEVED. A COMPETITOR'S PRODUCT WAS USED TO COMPLETE THE CASE SUCCESSFULLY, AND THERE WAS NO ADVERSE EFFECT TO THE PATIENT OR A CASE DELAY REPORTED. THE BONE QUALITY OF THE PATIENT WAS NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17817227 ↗