BIXCUT 0227-6105Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04546540145857), received between Feb 21, 2019 and Dec 21, 2025 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 21, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE REAMER WAS BENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23861060 ↗
• MalfunctionMar 6, 2023Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT AN IM FLEXIBLE REAMER WAS BROKEN DURING SURGERY WHICH RESULTED IN A 20 MINUTE SURGICAL DELAY. THERE WAS NO DEBRIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16484382 ↗
• MalfunctionJul 27, 2022Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT IM REAMERS BROKE DURING USE.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 15113555 ↗
• InjuryJul 29, 2021Break; Break

  IT WAS REPORTED VIA MEDWATCH (MW5101338) THAT MULTIPLE GRADUATED SIZED REAMERS ARE NEEDED TO PREPARE THE INTRAMEDULLARY CANAL FOR RECEIVING AN ORTHOPEDIC ROD OR NAIL. DURING A PROCEDURE TO REPAIR A LEFT COMMINUTED FEMORAL SHAFT FRACTURE, WHILE REAMING FOR THE INTRAMEDULLARY NAIL, THE FLEXIBLE REAMER BROKE IN THE FEMORAL CANAL. THE REAMER WAS TOO FLEXIBLE AND WOULD NOT ROTATE NOR COULD BE MALLETED OUT. THE SURGEON NEEDED TO TAKE AN ALTERNATE APPROACH FOR RETRIEVAL. THERE WAS AN INCREASED LENGTH OF TIME IN THE OPERATING ROOM IN ORDER TO ADDRESS THE ISSUE. THE SURGEON INDICATED APPROXIMATELY 45 MINUTES. THE PATIENT, DUE TO THIS EVENT, DID RECEIVE MORE ANESTHESIA BUT FROM A CLINICAL STANDPOINT WAS HEMODYNAMICALLY STABLE. THE BROKEN PART OF THE REAMER WAS SAFELY RETRIEVED FROM THE SURGICAL SITE. A NEW SET OF SURGICAL REAMERS WAS OBTAINED AND THE PROCEDURE WAS COMPLETED USING A SECOND ENTRY SITE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12248671 ↗
• MalfunctionFeb 21, 2019Break; Fracture; Fracture

  THE SURGEON REPORTED THAT DURING THE CASE THE 10.5 FLEXIBLE REAMER WAS USED AND THE TIP BROKE OFF LEAVING A PIECE IN THE FEMORAL CANAL. ATTEMPTS WERE MADE TO REMOVE THE PIECE BUT WERE UNSUCCESSFUL. THE CASE WAS COMPLETED AS THE PIECE WAS SUFFICIENTLY FAR DOWN THE CANAL THAT THE IMPLANT COULD STILL BE PLACED OVER THE TOP. THE SURGEON STATED THAT THE DEVICE IS NOT CANNULATED AND, AS A RESULT, IT IS MORE DIFFICULT TO REMOVE THE ITEM IF IT BREAKS BECAUSE OF THIS DESIGN FEATURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8359063 ↗