NA 208.875Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982149985), received between May 19, 2021 and May 19, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Difficult to Advance” (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.

• MalfunctionMay 19, 2021Difficult to Advance; Difficult to Advance

  IT WAS REPORTED THAT PATIENT UNDERWENT A PROCEDURE ON AN UNKNOWN DATE. THE SURGEON WAS PUTTING IN THE CANNULATED SCREW, WITHOUT CHECKING THE X-RAY. THEY CONTINUED TO DRIVE THE WIRE UNDER THE POWER SCREW ATTACHED TO THE CANNULATED SCREWDRIVER INTO THE FEMORAL HEAD. WHILE THEY DID, THE K-WIRE WENT THROUGH THE FEMORAL HEAD INTO THE ABDOMEN. THE GUIDEWIRE PENETRATED THE FEMORAL HEAD AND WENT INTO THE ACETABULUM AND RECTUM WHICH REQUIRED SURGICAL REPAIR. PROCEDURE WAS COMPLETED WITH AN UNKNOWN DELAY. PATIENT CURRENTLY NEEDS A COLOSTOMY BAG UNTIL HEALED. IT WAS FURTHER REPORTED THAT THERE APPEARS TO BE SOMETHING WRONG WITH THE SCREW. UPON INSPECTION AFTER INSERTION (VIA X-RAY), IT APPEARS TO HAVE SOMETHING IN IT PREVENTING THE CANNULA FROM EASILY MOVING THROUGH. THIS REPORT IS FOR A 7.3MM CANNULATED SCREW 16MM THREAD/75MM. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11847915 ↗