N/A 5407FA1015Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 07613327096699), received between Jul 20, 2020 and Jan 23, 2026 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Fracture” (9 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 23, 2026Fracture

  THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. EVENTS OCCURRED BETWEEN OCTOBER 1 ¿ DECEMBER 31 2025. THIS REPORT SUMMARIZES 1 EVENT FOR THE FAILURE: FRACTURE. - 1 EVENT HAD NO HEALTH CONSEQUENCES OR IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24163727 ↗
• MalfunctionApr 21, 2025Fracture; Fracture

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE OR CUTTING ACCESSORY FRACTURED. - 1 EVENT HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21876058 ↗
• MalfunctionJan 22, 2024Fracture; Fracture

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE OR CUTTING ACCESSORY FRACTURED. 1 EVENT HAD PATIENT INVOLVEMENT. NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18556891 ↗
• MalfunctionMar 22, 2023Fracture; Fracture

  IT WAS REPORTED VIA MEDWATCH (B)(4): THAT DURING A CRANIOTOMY RESECTION OF A TUMOR, THE ROUTER BROKE. IT WAS ALSO REPORTED THAT THERE WERE NO ADVERSE CONSEQUENCES, NO MEDICAL INTERVENTION AND NO DELAYS AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16593545 ↗
• MalfunctionOct 10, 2022Fracture; Fracture

  IT WAS REPORTED THAT DURING SERVICE EVALUATION, A BUR WAS FOUND INSIDE THE ATTACHMENT, IT WAS SUBSEQUENTLY CONFIRMED BROKEN DURING EVALUATION AT THE MANUFACTURING SITE. 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 15573434 ↗
• MalfunctionApr 12, 2022Fracture; Fracture

  IT WAS REPORTED THAT DURING A CRANIOTOMY PROCEDURE, THE ROUTER BROKE. IT WAS ALSO REPORTED THAT A X-RAY PERFORMED CONFIRMED THE BROKEN FRAGMENT WAS NOT INSIDE THE PATIENT AND THERE WAS A PROCEDURAL DELAY OF TWENTY MINUTES. IT WAS FURTHER REPORTED THAT THERE WERE NO ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14087578 ↗
• MalfunctionOct 12, 2021Fracture; Fracture

  IT WAS REPORTED THAT THE BUR BROKE AT THE TIP DURING A CRANIAL PROCEDURE. IT WAS ALSO REPORTED 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 12614993 ↗
• MalfunctionAug 4, 2020Fracture; Fracture

  IT WAS REPORTED THAT DURING A LUMBAR LAMINECTOMY, THE ROUTER BROKE AND BENT THE FOOT OF THE ATTACHMENT. IT WAS ALSO REPORTED THAT THERE WERE NO ADVERSE CONSEQUENCES AND NO DELAYS 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 10363327 ↗
• MalfunctionJul 20, 2020Fracture; Fracture

  IT WAS REPORTED THAT DURING CRANIOTOMY SURGERY, A ROUTER BROKE. IT WAS ALSO REPORTED THAT AN X-RAY WAS TAKEN AND A BROKEN FRAGMENT WAS LEFT BEHIND IN THE PATIENT. IT WAS FURTHER REPORTED THAT DURING A PLANNED FOLLOW UP PROCEDURE THE ROUTER FRAGMENT WAS REMOVED SUCCESSFULLY. IT WAS ALSO REPORTED 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 Known Impact Or Consequence To Patient

  MAUDE report 10295124 ↗