NA 530.680Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982240088), received between Feb 15, 2018 and Feb 15, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Overheating of Device” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 15, 2018Overheating of Device; Smoking; Overheating of Device; Smoking

  THIS IS REPORT 1 OF 2 FOR THE SAME EVENT: IT WAS REPORTED FROM (B)(6) THAT DURING A TOTAL JOINT REPLACEMENT SURGICAL PROCEDURE, IT WAS DISCOVERED THAT WHILE THE SURGEON WAS USING THE BATTERY REAMER/DRILL DEVICE, SMOKE STARTED COMING FROM THE BATTERY CASING DEVICE OF THE DRILL DEVICE. IT WAS REPORTED THAT ANOTHER BATTERY DEVICE WAS USED; HOWEVER, THE SAME ISSUE OCCURRED. THERE WERE NO DELAYS TO THE SURGICAL PROCEDURE AS SPARE DEVICES WERE AVAILABLE TO COMPLETE THE SURGERY. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THIS EVENT WAS UNKNOWN, HOWEVER IT WAS REPORTED THAT THE EVENT OCCURRED IN 2018. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7272910 ↗