NA 214.564Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982154262), received between Jul 17, 2018 and Jul 17, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (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.

• MalfunctionJul 17, 2018Break; Break

  IT WAS REPORTED THAT DURING A TIBIAL OSTEOTOMY PROCEDURE ON (B)(6) 2018, A PIECE OF THE THREADS AT THE END OF A 4.5MM CANNULATED SCREW APPEARED TO HAVE BROKEN OFF. DURING THE FINAL TIGHTENING, AFTER THE TWO SCREWS WERE IMPLANTED THROUGH THE OSTEOTOMY SITE, IT WAS NOTICED VIA X-RAY THAT ONE OF THE THREADS APPEARED BROKEN OFF. THE SCREW WAS REMOVED AND REPLACED WITH ANOTHER SCREW. IT IS NOTED THAT ONLY HAND TIGHTENING WAS PERFORMED DURING THE PROCEDURE WITH A CANNULATED 3.5 MM HEXAGONAL SCREWDRIVER. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH WAS NO SURGICAL DELAY REPORTED. ADDITIONAL X-RAYS WERE REQUIRED. THE PATIENT WAS IN STABLE CONDITION. CONCOMITANT DEVICES: 1.6MM THREADED GUIDEWIRE 150MM (PRODUCT: 292.72, LOT: UNKNOWN, QUANTITY: 1), CANNULATED 3.5MM HEXAGONAL SCREWDRIVER (PRODUCT: 314.20, LOT: UNKNOWN, QUANTITY: 1). THIS REPORT IS FOR A 4.5MM CANNULATED SCREW PARTIALLY THREADED/64MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7695831 ↗