NA 532.031Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982240699), received between Feb 19, 2020 and Feb 19, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Excessive Heating” (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. How this data works · Data updated Oct 13, 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.

• MalfunctionFeb 19, 2020Excessive Heating; Excessive Heating

  THIS IS REPORT 2 OF 2 FOR THE SAME EVENT. IT WAS REPORTED FROM (B)(6) THAT DURING AN OSTEOSYNTHESIS SURGERY FOR A HUMERAL SHAFT FRACTURE SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE RADIOLUCENT DRIVE DEVICE, WHILE BEING USED WITH AN ADAPTOR DEVICE, STOPPED DURING INSERTION OF THE DISTAL LOCKING SCREWS, WHICH MADE THE DEVICE UNUSABLE. IT WAS REPORTED THAT THERE WAS NO PROBLEM WHEN THE USER DRILLED NEAR THE CORTICAL BONE, HOWEVER THE DEVICE SOUND STOPPED GRADUALLY AND THEN FINALLY STOPPED WITH A TICKING SOUND. IT WAS NOTED THAT THE USER SWITCHED TO A FREEHAND DRILL DEVICE AND INSERTED THE FIRST LOCKING SCREW WITHOUT THE RADIOLUCENT DRIVE DEVICE. IT WAS FURTHER REPORTED THAT PRIOR TO THE INSERTION OF THE SECOND LOCKING SCREW, THE USER REPLACED THE BATTERY DEVICE AND THE DRILL BIT DEVICE WHICH HAD HEATED AND THE ADAPTER AND CONNECTING PART OF THE DEVICE WERE COOLED WITH SALINE. HOWEVER, DURING THE INSERTION OF THE SECOND SCREW, THE RADIOLUCENT DRIVE STOPPED AGAIN AND THE USER INSERTED THE SCREW WITH THE FREEHAND DRILL POINT. IT WAS REPORTED THAT THERE WAS A THIRTY MINUTE DELAY IN THE SURGICAL PROCEDURE. IT WAS NOTED THAT THE PATIENT HAD GOOD BONE QUALITY. IT WAS NOT REPORTED IF THERE W

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9728100 ↗