Arthrex® AR-623-6Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00888867198371), received between Mar 21, 2022 and Apr 29, 2024 — classified as 4 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 18, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 29, 2024Break; Break

  ON 04/04/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-623-6 KEEL PUNCH TOP SECTION BROKE OFF DURING IMPACTION. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT. CASE COMPLETED USING ANOTHER PUNCH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19201631 ↗
• MalfunctionApr 18, 2024Defective Device; Defective Device

  IT WAS REPORTED THAT THE ATTACHMENT SITE ON THE AR-623-6 IS DISTORTED MAKING IT DIFFICULT TO MAKE A SOLID CONNECTION. THIS WAS NOTICED UPON INSPECTION AFTER A TKA PROCEDURE.

  Patient problems: Insufficient Information

  MAUDE report 19133957 ↗
• MalfunctionNov 28, 2023Break; Break

  ON 11/2/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-613-1 IBALANCE TKA, HANDLE, MODULAR KEEL PUNCH, AND AN AR-623-6 IBALANCE TKA, KEEL PUNCH, SIZE 4-7 HAD AN ISSUE. THE HANDLE AND TIBIAL KEEL PUNCH CONNECTION BROKE OFF. THE CASE WAS COMPLETED SUCCESSFULLY WITHOUT FURTHER INFORMATION, AND NO PIECES BREAKING OFF INSIDE THE PATIENT. THIS WAS DISCOVERED DURING A TOTAL KNEE ARTHROPLASTY PROCEDURE ON 11/2/2023, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION RECEIVED ON 11/7/2023: AR-613-1 IBALANCE TKA, HANDLE, MODULAR KEEL PUNCH, AND AN AR-623-6 IBALANCE TKA, KEEL PUNCH BROKE OFF INSIDE THE PATIENT WITH ALL FRAGMENTS RETRIEVED FROM THE PATIENT. THE METAL PIECE THAT BROKE OFF THE KEEL PUNCH IS INSIDE THE TKA HANDLE. THE CASE WAS DELAYED 2 MINUTES AND COMPLETED USING PLYERS TO GET THE SIZE 4-7 KEEL PUNCH OUT OF THE PATIENT'S TIBIA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18223255 ↗
• MalfunctionMar 21, 2022Break

  ON (B)(6) 2021, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA SEMS THAT AN AR-623-T6 TIBIAL PREP TRAY AND AN AR-623-6 KEEL PUNCH ARE BROKEN. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2021.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13841187 ↗