Arthrex® AR-623-30Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888867224551), received between Nov 7, 2019 and Nov 7, 2019 — classified as 1 injury.

The most frequently reported specific device problem is “Mechanical Jam” (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.

• InjuryNov 7, 2019Mechanical Jam

  IT WAS REPORTED BY THE SALES REP, THAT DURING A TOTAL KNEE ARTHROPLASTY, THE AR-613-93, PATELLA MULTI TOOL, WOULD NOT LOCK INTO PLACE. THE REP HELD THE AR-613-93, IN PLACE DURING THE CEMENTING PROCESS OF THE PATELLA. THE SURGEON THEN TRIED TO USE THE AR-623-30, TIBAL GUIDE BUT, THE HEIGHT ADJUSTMENT ON THE GUIDE WOULD NOT REDUCE DOWN AND THEN JAMMED. THE CASE WAS COMPLETED USING AN AR-9401-14, INTRAMEDULLARY HUMERAL CUTTING GUIDE WITH NO FURTHER ISSUES. 10/21/2019: UPDATE FOR CLARIFICATION. PER LT1-0007-EN TOTAL KNEE ARTHROPLASTY SURGICAL TECHNIQUE, THE IBALANCE TKA INSTRUMENTS INCLUDE OPTIONS FOR RESECTING THE TIBIA USING EXTRAMEDULLARY OR INTRAMEDULLARY GUIDANCE. THE AR-623-30 USED WAS THE PROXIMAL BODY COMPONENT OF THE EXTRAMEDULLARY (EM) TIBIAL GUIDE INDICATING THAT AN EXTRAMEDULLARY SURGICAL TECHNIQUE WAS INITIALLY PURSUED. SINCE THE CASE WAS COMPLETED USING THE AR-9401-14 INTRAMEDULLARY HUMERAL CUTTING GUIDE, IT IS UNDERSTOOD THAT THE SURGICAL TECHNIQUE WAS CHANGED DURING SURGERY FROM AN EXTRAMEDULLARY TO AN INTRAMEDULLARY TIBIAL RESECTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9289993 ↗