NA 357.055Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982195753), received between Feb 19, 2020 and Feb 19, 2020 — 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.

• MalfunctionFeb 19, 2020Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON AN UNKNOWN DATE THAT THE TIP OF THE TORQUE X SCREWDRIVER WAS BROKE OFF DURING THE INTRAOPERATIVE EVENT. THERE WERE NO PARTS REMAINED IN THE PATIENT. THE SURGERY WAS DELAYED 5MN AND COMPLETED SUCCESSFULLY. THERE WAS NO ADVERSE PATIENT HARM. CONCOMITANT DEVICE REPORTED: UNKNOWN SCREW ( PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1). THIS IS REPORT 01 OF 01 OF (B)(4).

  Patient problems: No Code Available

  MAUDE report 9726978 ↗