NA 03.130.215Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982075376), received between Jul 18, 2022 and Jul 18, 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.

• InjuryJul 18, 2022Entrapment of Device; Entrapment of Device

  IT WAS REPORTED ON (B)(6) 2022, THAT THEY USED THE COUNTERSINK BEFORE IMPLANTING A SCREW, WHEN THE TOP OF THE COUNTERSINK BROKE OFF IN THE BONE OF THE PATIENT. FRAGMENTS WERE GENERATED. THE TIP OF THE COUNTERSINK REMAINED IN THE PATIENT¿S BONE. IT WOULD BE TOO DIFFICULT TO REMOVE THE PIECE. HE SAID HE WAS NOT WORRIED ABOUT LEAVING IT. THERE WAS NO SURGICAL DELAY. PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT CONSEQUENCE IS UNKNOWN. THIS REPORT IS FOR ONE (1) COUNTERSINK FOR 1.3/1.5 AND 2.0 SCREWS. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 15047754 ↗