NA 311.023.97Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982187246), received between Apr 14, 2021 and Nov 24, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (2 reports).

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 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 24, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE DOCTOR WAS USING THE RATCHET SCREW DRIVER OUT OF THE DISTAL RADIUS SYSTEM. HE WAS UNABLE TO FLIP THE SWITCH TO ADJUST THE RATCHET ASPECT OF THE SCREW DRIVER. ALSO FOLLOWING THE CASE, THE SCREW DRIVER BLADE WAS UNABLE TO BE DISCONNECTED FROM THE BLACK RATCHET HANDLE. A DIFFERENT SCREWDRIVER WAS USED. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO PATIENT CONSEQUENCES/OUTCOME. THIS REPORT IS FOR ONE (1) RATCHETING SCREWDRIVER HANDLE. THIS IS REPORT 2 OF 2 FOR COMPLAINT: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18204616 ↗
• MalfunctionApr 14, 2021Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE RATCHETING SCREWDRIVER HANDLE WOULD NOT HOLD THE T8 SCREWDRIVER BLADE. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) RATCHETING SCREWDRIVER HANDLE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11665481 ↗