Arthrex® AR-613-50Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10888867116549), received between Feb 22, 2021 and May 16, 2024 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 16, 2024Break; Break

  ON 12/13/2021, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA E-MAIL THAT AN AR-611DR07 AND AR-613-50 INSTRUMENT BROKEN. THIS WAS DISCOVERED DURING A UNI KNEE ARTHROPLASTY ON (B)(6) 2021. THE AR-613-50 BROKE OFF INSIDE PIN HOLE OF ITEM AR-611DR07. DEVICE WAS REMOVED AND THE CASE WAS COMPLETED BY USING A NEW AR-611DR07 AND AR-613-50.

  Patient problems: Insufficient Information

  MAUDE report 19331379 ↗
• MalfunctionJul 12, 2023Break; Break

  ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT A UKA STABILIZING PIN (AR-613-50) BROKE INSIDE OF THE PIN DRIVER (AR-613-91). THE BROKEN PIN WAS UNABLE TO BE REMOVED FROM THE PIN DRIVER DEEMING IT UNUSABLE DURING THE CASE. AND A TIBIAL IMPACTOR (AR-611-4) TIP BROKE OFF UPON IMPACTING THE TIBIAL TRIAL. THIS WAS DISCOVERED DURING A CASE, DEVICES BROKE DURING USE. ALL FRAGMENTS ABLE TO BE REMOVED.

  Patient problems: Insufficient Information

  MAUDE report 17304674 ↗
• MalfunctionFeb 22, 2021Break; Entrapment of Device

  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. 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 ALSO BROKEN.

  Patient problems: Insufficient Information

  MAUDE report 11358089 ↗