NA SD314.001Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982004567), received between Apr 28, 2021 and Apr 28, 2021 — 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.

• MalfunctionApr 28, 2021Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT AN UNKNOWN SURGICAL PROCEDURE FOR AN UNKNOWN REASON. THE SURGEON WAS INSERTING A 3.5MM CORTICAL SCREW WITH A SMALL HEXAGONAL PELVIC SCREWDRIVER. AFTER THE SCREW WAS INSERTED INTO THE BONE, THE DRIVER WOULD NOT DISENGAGE. THE SURGEON WAS ABLE TO REMOVE THE SCREWDRIVER BY USING A MALLET TO KNOCK THE DRIVER BACK AND IN THE PROCESS, THE HANDLE BROKE APART FROM THE 2.5 HEX SHAFT. MALLET DRIVER OUT FOLLOWED BY USING ANOTHER HEX DRIVER INSTRUMENT. FRAGMENTS WERE GENERATED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A SURGICAL DELAY OF FIVE (5) MINUTES. THERE WAS NO PATIENT CONSEQUENCE. CONCOMITANT DEVICE REPORTED: UNKNOWN MALLET (PRODUCT# UNKNOWN, LOT# UNKNOWN, QTY UNKNOWN). THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR (1) SMALL HEXAGONAL PELVIC SCREWDRIVER/LARGE HANDLE. THIS REPORT IS 1 OF 2 (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11737826 ↗