MalfunctionHTW
ACUTRAK 2® - 4.7 PROFILE DRILL
Received Jun 30, 2026 · Event occurred May 1, 2026
Report 3025141-2026-00345 · MDR key 25672008
Device
Product problems
- Break
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
TO DATE, THE DEVICE HAS NOT RETURNED FOR EVALUATION BUT HAS BEEN REPORTED TO ACUMED THAT IT WILL BE RETURNED FOR EXAMINATION. ADDITIONAL REPORTING ON THIS EVENT WILL BE PROVIDED AS A FOLLOW UP REPORT WHEN THE DEVICES HAVE BEEN RETURNED AND EXAMINED.
Description of Event or Problem
IT WAS REPORTED THAT THE DRILL BROKE DURING USE. THE BROKEN PIECE WAS ABLE TO BE REMOVED AND IS NOT LEFT BEHIND IN THE BODY.