BIXCUT 0226-3000SRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613153281641), received between Dec 3, 2018 and Jan 28, 2022 — classified as 2 malfunctions.

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.

• MalfunctionJan 28, 2022Device Difficult to Setup or Prepare; Device Contaminated During Manufacture or Shipping; Device Difficult to Setup or Prepare; Device Contaminated During Manufacture or Shipping

  THE CUSTOMER REPORTED TO ANSM UNDER REF NUMBER: (B)(4) THE FOLLOWING INCIDENT: "DATE OCCURRED: ON (B)(6) 2021. INCIDENT DESCRIPTION: PRESENCE OF A PIECE OF PLASTIC AT THE END WHERE THE BORING OLIVES SHOULD BE POSITIONED. RISK OF LEAVING PLASTIC IN THE FEMORAL DIAPHYSIS DURING REAMING. THE OFFENDING REAMER WAS NOT USED ON THE PATIENT: ANOTHER REAMER WAS OPENED. THE INCRIMINATED REAMER IS AVAILABLE FOR EXPERTISE UPON REQUEST FROM THE LABORATORY TO THE MATERIAL SAFETY OFFICER."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13388720 ↗
• MalfunctionDec 3, 2018Break

  THE HOSPITAL CALL TO REPORT THE FOLLOWING EVENT: WHEN OPENING THE BOX DURING THE PROCEDURE THE BLISTER IS COMPLETELY DAMAGED. USING ANOTHER DEVICE TO COMPLETE THE PROCEDURE. NEED TO RE-STERILIZE THE SURGICAL FIELD. NO PATIENT IMPACT. SURGICAL DELAY OF 15MIN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8124228 ↗