ACCULAN 3TI GB638RRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04038653408214), received between Mar 12, 2021 and Mar 12, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Electrical /Electronic Property Problem” (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 18, 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.

• MalfunctionMar 12, 2021Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED TO AESCULAP AG THAT AN ACCULAN 3TI DRILL ATTACHM.LARGE JACOBS (PART # GB638R) WAS USED DURING A TOTAL KNEE ARTHROPLASTY (TKA) NAVIGATION SURGICAL PROCEDURE PERFORMED ON (B)(6) 2021. ACCORDING TO THE COMPLAINANT, FOLLOWING THE OSTEOTOMY OF THE PROXIMAL TIBIA, AS THE PHYSICIAN ATTEMPTED TO PIN THE DISTAL FEMUR OSTEOTOMY BLOCK, THE DEVICE MOTOR ROTATED FOR 1 TO 2 SECONDS, AND THEN STOPPED. THE BATTERY AND ATTACHMENT WERE REPLACED, BUT THE ISSUE RECURRED. THE SURGERY WAS SUCCESSFULLY COMPLETED USING ANOTHER TYPE OF DEVICE. THE COMPLAINT DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. THIS EVENT/MALFUNCTION PROLONGED THE SURGERY FOR APPROXIMATELY TEN (10) MINUTES. ALTHOUGH REQUESTED, ADDITIONAL INFORMATION HAS NOT BEEN MADE AVAILABLE. THE MALFUNCTION IS FILED UNDER AAG REFERENCE (B)(4). ASSOCIATED MEDWATCH-REPORTS: 9610612-2021-00156 ((B)(4) + GA672), 9610612-2021-00160 ((B)(4) + GB636R), AND 9610612-2021-00168 ((B)(4) + GA675).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11475575 ↗