NA 2351-3028SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613327361735), received between May 23, 2022 and May 23, 2022 — classified as 1 injury.

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.

• InjuryMay 23, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  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 14469129 ↗