NA 04.005.516SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982085856), received between May 29, 2020 and May 29, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Use of Device Problem” (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 18, 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 29, 2020Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT ON (B)(6) 2020 DURING THE INSERTION OF A TIBIA NAIL AND PROXIMAL INTERLOCK THERE WAS DIFFICULTY SCREWING THE AIMING ARM FOR SUPRAPATELLAR UNTO THE INSERTION HANDLE FOR SUPRAPATELLAR. THE AIMING ARM FELT STRIPPED. THE AIMING ARM WAS EVENTUALLY SCREWED ON AND WAS USED IN THE PROCEDURE. REMOVAL OF THE AIMING ARM WAS ALMOST IMPOSSIBLE, WHICH CAUSED THE SURGEON TO MEASURE THE TI LOCKING SCREW THROUGH THE AIMING ARM. THE LOCKING SCREW MEASURED TOO SHORT AND COULD NOT BE USED. ANOTHER LONGER, UNKNOWN SCREW WAS USED INSTEAD. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE OUTCOME AND PATIENT STATUS ARE UNKNOWN. CONCOMITANT DEVICES REPORTED: INSERTION HANDLE FOR SUPRAPATELLAR (PART NUMBER 03.010.440, LOT 170472-101, QUANTITY 1), AIMING ARM FOR SUPRAPATELLAR (PART NUMBER 03.010.441, LOT 170387, QUANTITY 1). THIS REPORT INVOLVES ONE (1) 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 26MM F/IM NAIL-STER. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10100720 ↗