Concept Grafix CR8850Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10845854021842), received between Sep 12, 2022 and Dec 30, 2022 — classified as 1 injury, 1 malfunction.

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

• MalfunctionDec 30, 2022Material Fragmentation; Material Fragmentation

  THE DISTRIBUTOR REPORTED ON BEHALF OF THE CUSTOMER THAT THE DEVICE, CR8850 CONCEPT GRAFIX CORING REAMER 10MM, QTY 4 WAS BEING USED ON (B)(6) 2022 DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION AND ¿REAMER BROKEN DURING USE¿. THERE WAS NO IMPACT OR INJURY TO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH AN ALTERNATE SAME DEVICE. AFTER FURTHER ASSESSMENT IT WAS FOUND THAT FRAGMENTS FELL INTO THE SURGICAL SITE AND WERE RETRIEVED. THERE WAS A 15-30 MINUTE DELAY, ¿BECAUSE THE SURGEON REMOVED THE BROKEN PIECE OF THIS COMPLAINT PRODUCT¿. THERE WAS NO REPORT OF MEDICAL/SURGICAL INTERVENTION OR PROLONGED HOSPITALIZATION FOR THE PATIENT. THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16077896 ↗
• InjurySep 12, 2022Break; Break

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE CR8850, CONCEPT GRAFIX CORING REAMER 10MM, WAS BEING USED ON (B)(6) 2022 DURING UNKNOWN PROCEDURE WHEN IT WAS REPORTED ¿REAMER METAL SHREDDED IN THE KNEE CAUSING LARGE HOLE IN TIBIA. THEY HAD TO USE 15CC BONE GRAFT TO FILL VOID CAUSED BY REAMER.¿ THERE WAS ALSO 2-HOUR DELAY REPORTED IN THE PROCEDURE. FURTHER ASSESSMENT QUESTIONING WAS REQUESTED, TO DATE THE REPORTER HAS NOT RESPONDED. THERE WAS NO REPORTED HOSPITALIZATION FOR THE PATIENT AND THE CURRENT STATUS OF THE PATIENT IS UNKNOWN. THIS REPORT IS BEING RAISED ON THE BASIS OF INJURY DUE TO LARGE HOLE IN THE TIBIA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15404245 ↗