Arthrex® AR-611-TRLMRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888867229167), received between Jun 9, 2024 and Jun 9, 2024 — classified as 1 injury.

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.

• InjuryJun 9, 2024Break; Break

  IT WAS REPORTED DURING A PARTIAL KNEE REPLACEMENT A SMOOTH GUIDE PIN COLD WELDED INTO THE AR-611-TRLM LEFT TIBIAL CUTTING GUIDE. THE SURGEON WAS ABLE TO COMPLETE THE CUT WITH A SINGLE PIN IN PLACE AND HOLDING THE GUIDE IN PLACE. DURING THE PROCEDURE A SMALL PIECE OF THE AR-601-TBE8 8MM TRIAL BROKE OFF. THE REP REPORTED THE PIECE WAS EASILY RETRIEVED, BUT THROWN OUT. SEE SOURCE DATA AND IMAGE ATTACHED. ADDITIONAL INFORMATION RECEIVED ON 1/25/21: THE TRIAL POLY BROKE WHILE INSERTING IT FOR TRIAL. IT BROKE INTO TWO DISTINCT PIECES WHILE TRIALING IT IN THE KNEE. THE SMALLER PIECE THAT BROKE OFF FELL ONTO THE OR TABLE AND WAS DISCARDED AFTER ASSESSING THAT THE TWO PIECES ACCOUNTED FOR THE ENTIRE TRIAL COMPONENT AND THERE WAS NO MISSING PIECE. THERE WERE NO UNPLANNED INCISIONS. THE CASE WAS COMPLETED WITHOUT DIFFICULTY, AS THE REMAINING TRIAL COMPONENT WAS ADEQUATE TO TRIAL AND THE DECISION FOR THE FINAL IMPLANTABLE COMPONENT WAS MADE. ADDITIONAL INFORMATION OBTAINED ON 2/4/21: THE COMPLAINT PRODUCT (AR-601-TBE8 AND AR-611-TRLM) WAS RETURNED FOR EVALUATION. THE DEFECTIVE PIN AR-613-50 (LOT: 011950) WAS RETURNED STUCK WITHIN THE GUIDE. UPON INVESTIGATION IT WAS NOTED THAT AR-613-50 IS ALS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19495209 ↗