NA 310.35Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982186515), received between Jul 27, 2017 and May 4, 2026 — classified as 2 malfunctions.

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

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 4, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT THE 3.5MM DRILL BIT/QC/110MM FAILED TO ENGAGE INTO THE POWER ATTACHMENT AO QUICK CONNECT DURING PRE-OPERATIVE SETUP. THE EVENT WAS DISCOVERED BEFORE THE PROCEDURE, AND THE DEVICE WAS AVAILABLE FOR RETURN. THERE WAS NO REPORTED PATIENT HARM OR SIGNIFICANT DELAY, AND NO PATIENT INVOLVEMENT OR CLINICAL SYMPTOMS WERE IDENTIFIED AS A CONSEQUENCE OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25067134 ↗
• MalfunctionJul 27, 2017Break; Device Operates Differently Than Expected; Break; Device Operates Differently Than Expected

  DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT PARTS WERE DETECTED AS DAMAGED DURING INTERNAL INSPECTION OF LOANER KITS. REPORTEDLY THERE WAS NO PATIENT OR PROCEDURE INVOLVEMENT. THIS REPORT IS FOR DRILL BIT WHICH REPORTEDLY DID NOT FIT WITH OTHER PARTS. WHEN THE DEVICE WAS RECEIVED, IT WAS NOTED THAT THE DISTAL TIP WAS BROKEN; THE BROKEN PORTION WAS NOT RECEIVED. THIS REPORT IS FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 6748030 ↗