Arthrex® AR-602-28Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888867038257), received between Dec 6, 2024 and Dec 6, 2024 — classified as 1 injury.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (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.

• InjuryDec 6, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  ON 11/11/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-602-28 IBALANCE¿ PFJ BLADE KIT FRACTURED THE LEFT FEMORAL CONDYLE WHILE PREPPING THE FEMUR WITH A BLADE KIT DURING A CASE. THE CASE WAS COMPLETED SUCCESSFULLY, AND NO FURTHER INFORMATION WAS PROVIDED. NO PIECES BROKE INSIDE THE PATIENT REPORTED. THIS WAS DISCOVERED DURING A PFJ PROCEDURE ON (B)(6) 2024. ADDITIONAL INFORMATION WAS RECEIVED ON 11/14/2024: THE REP STATED THAT THE CONDYLE FRACTURED WHILE THE SURGEON IMPACTED THE PROXIMAL BLADE AND USED THE STANDARD SURGICAL TECHNIQUE INDICATED. AFTER THE FRACTURE, A NON-ARTHREX HEADLESS SCREW WAS USED TO STABILIZE THE FRACTURE, AND AN ARTHREX IBALANCE PFJ SYSTEM COMPLETED THE CASE WHILE USING THE STANDARD TECHNIQUE. THERE WAS A 10-MINUTE DELAY WHILE THEY WAITED FOR THE NON-ARTHREX PRODUCT TO BE RECEIVED. NO X-RAYS ARE AVAILABLE OF THE PATIENT. NO MEDICAL INTERVENTION OR HOSPITALIZATION WAS NEEDED FOR THE PATIENT, AND NO ADDITIONAL SURGERY WAS REQUIRED.

  Patient problems: Bone Fracture(s)

  MAUDE report 20865443 ↗