NA 332.062Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982192516), received between Sep 27, 2022 and Sep 27, 2022 — classified as 1 injury.

The most frequently reported specific device problem is “Entrapment of Device” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjurySep 27, 2022Entrapment of Device; Entrapment of Device

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020, DURING AN OPEN REDUCTION AND INTERNAL FIXATION OF A PATIENT¿S DISTAL HUMERUS, ONE OF THE DRILL BITS BROKE. THE SURGEON DETERMINED IT WOULD BE TOO DIFFICULT TO RETRIEVE THE PIECE AND THE TIP WAS LEFT IT IN PLACE. TIP OF BROKEN DRILL BIT REMAINED IN PATIENT'S BONE. THIS REPORT INVOLVES ONE ROUTER QC 130MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Foreign Body In Patient; Unspecified Tissue Injury

  MAUDE report 15493582 ↗