NA 310.143Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982186003), received between Mar 6, 2019 and Mar 6, 2019 — classified as 1 malfunction.

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. 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 6, 2019Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING CORONOID FRACTURE USING MODULAR HAND 2.0MM MODULE, THE DRILL BIT STRYKER BROKE. THE FLUTED PORTION OF THE DRILL WAS DISPOSED. THE SHAFT OF THE DRILL REMAINED IN THE STRYKER POWER ATTACHMENT. IT IS UNKNOWN IF THE DRILL BIT BROKE IN THE BONE OR BEFORE INSERTION INTO THE BONE. THE DRILL BIT WAS NOT USED IN TANDEM WITH A DRILL GUIDE WHICH MAY HAVE ALLOWED THE DRILL BIT TO DEFORM UNDER THE DRILLS HIGH REVOLUTION PER MINUTE (RPM). A NEW DRILL BIT WAS SELECTED TO FINISH THE PROCEDURE. FRAGMENTS WERE GENERATED FROM THE BROKEN DEVICE AND WERE REMOVED. THERE WAS A SURGICAL DELAY OF AN UNKNOWN DURATION. PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT OUTCOME WAS AS EXPECTED. CONCOMITANT DEVICE REPORTED: UNKNOWN DRILL BIT (PART# UNKNOWN, LOT # UNKNOWN, QUANTITY 1), UNKNOWN MODULE (PART# UNKNOWN, LOT # UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) 1.5MM DRILL BIT STRYKER J-LATCH/75MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8394346 ↗