NA 202.716Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982144492), received between Sep 28, 2021 and Sep 28, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device-Device Incompatibility” (1 report).

1 other recall cover devices cleared under the same FDA submission (K951304, K962823); they may or may not involve this specific model.

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.

• MalfunctionSep 28, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT, THE CANNULATED CRUCIFORM SCREWDRIVER WAS STRIPPED UPON INSERTION OF THE CANNULATED SCREW HEAD. THERE WERE FIVE MINUTES SURGICAL DELAY AND NO PATIENT CONSEQUENCE REPORTED. THIS REPORT IS FOR ONE (1) 3.0MM CANNULATED SCREW LONG THREAD/16MM. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12541582 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K951304, K962823. One submission often covers many models, so check the product and lot details in each record.

• Z-2265-2014 · Jun 30, 2014 · Terminated
  Synthes 3.0 MM TI Cannulated Screw Instrument and Implant Set