NA 360.05Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982197368), received between Apr 14, 2020 and Apr 14, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device-Device Incompatibility” (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.

• MalfunctionApr 14, 2020Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED ON AN UNKNOWN DATE THAT DURING INSERTION OF AN UNKNOWN NAIL INTO THE PATIENT'S HUMERUS ON (B)(6) 2020, THE LARGE CANNULATED DRILL BIT WOULD NOT GO OVER THE UNKNOWN GUIDE PIN. UPON CHECKING, THE TIP OR THE REPORTED DRILL BIT LOOKED TO BE DAMAGED IN A WAY THAT THE GUIDE PIN COULD NOT GO THROUGH IT. THE SURGEON HAD TO USE ANOTHER INSTRUMENT TO COMPLETE THE CASE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH FIVE (5) MINUTES SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE REPORTED. CONCOMITANT DEVICE REPORTED: UNKNOWN GUIDE PIN (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1), UNKNOWN NAIL (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY UNKNOWN). THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 9959056 ↗