NA 312.151Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982187642), received between Nov 30, 2018 and May 22, 2019 — 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 22, 2019Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT AN ORTHOPEDIC PROCEDURE. DURING THE PROCEDURE, THE TIP OF THE DOUBLE DRILL GUIDE (1.1MM END) BROKE OFF. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO PATIENT CONSEQUENCE. THIS REPORT IS FOR ONE (1) 2.0MM/1.1MM DOUBLE DRILL SLEEVE THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8633206 ↗
• MalfunctionNov 30, 2018Device-Device Incompatibility; Device-Device Incompatibility

  01/03/2019: UPDATED EVENT DESCRIPTION: IT WAS REPORTED THAT ON AN UNKNOWN DATE, AN UNKNOWN KIRSCHNER WIRE WAS BROKEN AND STUCK, ALONG WITH THE DOUBLE DRILL GUIDE, IT'S UNKNOWN WHEN THE ISSUE OCCURRED..ADDITIONALLY, IT IS UNKNOWN IF THERE WAS ANY PATIENT OR PROCEDURE INVOLVEMENT. THIS COMPLAINT INVOLVES TWO (2) DEVICES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8121558 ↗