NA 219400Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886705006250), received between Oct 19, 2021 and Dec 23, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Degraded” (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 16, 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.

• MalfunctionDec 23, 2025Degraded; Degraded

  IT WAS REPORTED THAT THE CORTICAL TAP 4.5 MM DEVICE HAD THREADS THAT DID NOT ENGAGE THE DRILL HOLE THUS ALLOWING THE TAP TO INSERT AND PREP FOR THE SCREW. IT WAS NOT REPORTED IF THE DEVICE WAS USED IN SURGERY. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT WAS UNKNOWN. HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN 2025. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23882423 ↗
• MalfunctionOct 19, 2021Degraded; Degraded

  IT WAS REPORTED BY THE SALES REP THAT DURING A TIBIAL TYPICAL TRANSFER PROCEDURE ON (B)(6) 2021, IT WAS OBSERVED THAT THE SCR/WASH CORTTAP 4.5MM DEVICE WAS DULL. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH A DELAY OF 15 MINUTES. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12658537 ↗