NA 324.107Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705034769349), received between Jul 18, 2019 and Jul 18, 2019 — classified as 1 injury.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (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, 2019Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2019, RIGHT BEFORE THE SURGERY, WHEN THE NURSE SET UP THE REPORTED HANDLE WITH DRILL BIT, THE NURSE RECOGNIZES THAT THERE WAS A FAIR FIBER LIKE FOREIGN MATERIAL THAT WAS ADHERED TO THE BOTTOM OF THE HANDLE. THUS, ALL EQUIPMENT INCLUDING THE REPORTED DEVICES HAD TO BE STERILIZED AGAIN. AS THE RESULTS, THE SURGERY WAS POSTPONED. PATIENT INVOLVEMENT WAS UNKNOWN. CONCOMITANT DEVICE REPORTED: UNKNOWN DRILL BIT (PART#UNKNOWN, LOT#UNKNOWN, QUANTITY 1). THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 8804899 ↗