Arthrex® AR-623-55Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888867214729), received between Nov 7, 2022 and May 27, 2024 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 27, 2024Break; Break

  IT WAS REPORTED ON 11/01/2022 BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-623-55 CUTTING GUIDE BROKE OFF INSIDE THE AR-613-99 SLAP HAMMER. CASE INVOLVEMENT, NO PATIENT EFFECT. NOTHING BROKE OFF INSIDE THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19399353 ↗
• MalfunctionNov 7, 2022Break

  ON (B)(6) 2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT A AR-623-55 FEMORAL CUTTING BLOCK BROKE. THIS OCCURRED ON (B)(6) 2022 DURING A TOTAL KNEE ARTHROPLASTY AS THE SURGEON WAS REMOVING THE SIZE 5 CUTTING BLOCK (AR-623-55) FROM THE FEMUR, A PIECE IN THE CENTER OF THE BLOCK BROKE OFF PREVENTING THE SLAP HAMMER TO ENGAGE WITH THE BLOCK. THE PATIENT HAD GOOD BONE QUALITY. THE CASE WAS COMPLETED WHEN THE SURGEON MADE HIS FEMORAL CUTS AND WAS ABLE TO GET THE BLOCK HALFWAY OUT BEFORE IT BROKE. AFTER THAT, HE USED A MALLET AND OTHER MISCELLANEOUS INSTRUMENTATION ON THE BACK TABLE PROVIDED BY THE OR TO REMOVE THE BLOCK. THE CASE WENT ON PER USUAL AFTER THAT.

  Patient problems: Insufficient Information

  MAUDE report 15742775 ↗