BIXCUT 0227-8510SRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04546540722317), received between Mar 5, 2020 and May 23, 2022 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Failure to Align” (2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryMay 23, 2022Residue After Decontamination; Failure to Align; Residue After Decontamination; Failure to Align

  IT WAS REPORTED THROUGH THE FILING OF A LAWSUIT THAT ALLEGEDLY THE PATIENT SUFFERED A RIGHT TIBIA AND FIBULA FRACTURE FROM A DIRT BIKE ACCIDENT AND ON (B)(6) 2020 THE PLAN WAS TO REMOVE A PILON PLATE THAT HAD BEEN PLACED IN THE PATIENT'S LEG TEN YEARS PRIOR AND REPAIR THE FRACTURE WITH INTRAMEDULLARY NAILING. A REAMER WAS SUPPOSED TO BE USED TO GO INTO THE TIBIA AND ALLEGEDLY "BOTH OF OUR REAMERS HAD FOREIGN MATERIAL FROM FORMER SURGERY" AND THEREFORE A "FLEXIBLE INTRA REAMER WAS THEN USED TO ENTER INTO THE CORRECT STARTING POSITION... THIS FLEXIBLE REAMER DID NOT FOLLOW THE GUIDE PIN AS HOPED AND MADE A SMALL 6-8 MM HOLE ON THE ANTERIOR CORTEX OF THE TIBIA." ALLEGEDLY HE CONTINUES TO SUFFER FROM KNEE PAIN, STIFFNESS AND TIGHTNESS, POSSIBILITY OF COMPARTMENT SYNDROME THAT MAY BE CAUSING HIS POSSIBLE NERVE INJURY.

  Patient problems: Implant Pain; Loss of Range of Motion; Nerve Damage

  MAUDE report 14469147 ↗
• MalfunctionMay 23, 2022Residue After Decontamination; Failure to Align; Residue After Decontamination; Failure to Align

  IT WAS REPORTED THROUGH THE FILING OF A LAWSUIT THAT ALLEGEDLY THE PATIENT SUFFERED A RIGHT TIBIA AND FIBULA FRACTURE FROM A DIRT BIKE ACCIDENT AND ON 21-APR-2020 THE PLAN WAS TO REMOVE A PILON PLATE THAT HAD BEEN PLACED IN THE PATIENT'S LEG TEN YEARS PRIOR AND REPAIR THE FRACTURE WITH INTRAMEDULLARY NAILING. A REAMER WAS SUPPOSED TO BE USED TO GO INTO THE TIBIA AND ALLEGEDLY "BOTH OF OUR REAMERS HAD FOREIGN MATERIAL FROM FORMER SURGERY" AND THEREFORE A "FLEXIBLE INTRA REAMER WAS THEN USED TO ENTER INTO THE CORRECT STARTING POSITION... THIS FLEXIBLE REAMER DID NOT FOLLOW THE GUIDE PIN AS HOPED AND MADE A SMALL 6-8 MM HOLE ON THE ANTERIOR CORTEX OF THE TIBIA." ALLEGEDLY HE CONTINUES TO SUFFER FROM KNEE PAIN, STIFFNESS AND TIGHTNESS, POSSIBILITY OF COMPARTMENT SYNDROME THAT MAY BE CAUSING HIS POSSIBLE NERVE INJURY.

  Patient problems: Implant Pain; Loss of Range of Motion; Nerve Damage

  MAUDE report 14469127 ↗
• MalfunctionMar 5, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  PRIMARY PROCEDURE, RIGHT TOTAL HIP ARTHROPLASTY. IT WAS REPORTED THAT THE SURGEON WANTED A FLEXIBLE REAMER. A TRINKLE BIXCUT SHAFT AND BIXCUT IM REAMER HEAD WERE USED. WHEN ASKED, THE SURGEON DECLINED THE USE OF THE GUIDE ROD WITH THE CONSTRUCT. AFTER REAMING, THE REAMER HEAD DISENGAGED FROM THE SHAFT IN THE PATIENT'S FEMUR. AFTER TRYING TO RETRIEVE THE DEVICE, THE SURGEON DECIDED TO LEAVE THE REAMER HEAD IN THE PATIENT. SURGERY WAS COMPLETED WITH A DELAY OF APPROXIMATELY 15 TO 20 MINUTES. REP REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 9795162 ↗