N/A 5407FA3030Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07613327096736), received between Jan 10, 2017 and Nov 4, 2019 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Break” (3 reports).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryNov 4, 2019Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT DURING A LUMBAR LAMINECTOMY, THE DRILL STALLED AND THE DURA WAS TORN WITH THE ROUTER. IT WAS ALSO REPORTED THAT THERE WAS A FIVE MINUTE DELAY WHILE THE SURGEON REPAIRED THE DURA. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: Abrasion

  MAUDE report 9272907 ↗
• MalfunctionMay 14, 2019Break; Break

  IT WAS REPORTED VIA THE SALES REPRESENTATIVE THAT THE BUR BROKE DURING TESTING AND WAS RETAINED IN THE HANDPIECE. IT WAS ALSO REPORTED THAT THIS EVENT DID NOT OCCUR DURING A SURGICAL PROCEDURE, AND THERE WAS NO DELAY OR ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 8608126 ↗
• MalfunctionApr 4, 2018Break; Break

  IT WAS REPORTED THAT DURING A CRANIOTOMY WITH TUMOUR RESECTION, THE ROUTER BROKE AT THE CUTTING END. IT WAS ALSO REPORTED THAT THERE WERE NO DELAYS AND NO ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7395357 ↗
• MalfunctionJan 10, 2017Break; Break

  IT WAS REPORTED THAT DURING A PRODUCT DEMONSTRATION WITH THE PI DRIVE PLUS MOTOR, THE ROUTER BROKE. IT WAS ALSO REPORTED THAT THIS EVENT DID NOT OCCUR DURING A SURGICAL PROCEDURE, AND THERE WAS NO DELAY OR ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 6239283 ↗