NA 71177188Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00885556017197), received between Mar 26, 2021 and Mar 26, 2021 — classified as 3 injuries.

The most frequently reported specific device problem is “Dull, Blunt” (3 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryMar 26, 2021Dull, Blunt; Dull, Blunt

  IT WAS REPORTED THAT THE 1.3MM CANN COUNTERSINK W/QC IS DULL AND NEEDS TO BE REPLACED. THE DEVICE WAS FOUND DEFECTIVE DURING SURGERY. A STRYKER 4.0MM CANNULATED SCREW (COMPETITOR'S DEVICE) WAS USED IN ORDER TO COMPLETE THE PROCEDURE. NO SURGICAL DELAY OR INJURY TO THE PATIENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11573368 ↗
• InjuryMar 26, 2021Dull, Blunt; Dull, Blunt

  IT WAS REPORTED THAT THE 1.3MM CANN COUNTERSINK W/QC IS DULL AND NEEDS TO BE REPLACED. THE DEVICE WAS FOUND DEFECTIVE DURING SURGERY. A STRYKER 4.0MM CANNULATED SCREW (COMPETITOR'S DEVICE) WAS USED IN ORDER TO COMPLETE THE PROCEDURE. NO SURGICAL DELAY OR INJURY TO THE PATIENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11573366 ↗
• InjuryMar 26, 2021Dull, Blunt; Dull, Blunt

  IT WAS REPORTED THAT THE 1.3MM CANN COUNTERSINK W/QC WAS NOTICED DULL. NO DELAY OR INJURY REPORTED. THE PROCEDURE WAS FINISHED USING A COMPETITOR DEVICE. THE PHYSICIAN USED A STRYKER 4.0 MM CANNULATED SCREW TO FINISHED THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11573364 ↗