NA 314.431Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982188823), received between Aug 14, 2019 and Aug 14, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device-Device Incompatibility” (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 18, 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.

• MalfunctionAug 14, 2019Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THIS WAS A CRANIOPLASTY PROCEDURE PERFORMED ON (B)(6) 2019. WHEN THE SURGEON TRIED TO FIX A SCREW WITH THE REPORTED SCREWDRIVER (314.431), S/HE WAS NOT ABLE TO RAISE THE SLEEVE. THE SURGERY WAS COMPLETED WITHOUT SURGICAL DELAY. CONCOMITANT DEVICES REPORTED: UNKNOWN SCREW (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1) THIS REPORT IS FOR ONE (1) 1.5MM CRUCFRM SCREWDRIVER BLD W/SPRING HLDG SLV F/RESORB MQC. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8892763 ↗