NA 04.005.570SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982086396), received between May 10, 2018 and May 10, 2018 — classified as 1 injury.

The most frequently reported specific device problem is “Failure to Align” (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.

• InjuryMay 10, 2018Failure to Align; Failure to Align

  IT WAS REPORTED THAT A DISTAL INTERLOCK DID NOT ALIGN WITH THE NAIL AS EXPECTED. THE ISSUE HAPPENED DURING A RETROGRADE FEMORAL NAIL SURGERY ON (B)(6) 2018. THE ISSUE WAS NOTICED WHEN THE SURGEON TOOK THE FINAL X-RAYS. IT WAS THEN FOUND THAT THE SCREW DID NOT GO THROUGH THE NAIL. THE SURGEON MADE THE DECISION TO MOVE THE DEVICE AND MANUALLY SCREW IT THROUGH THE NAIL, CAUSING A 30-MINUTE DELAY. THE PATIENT WAS STABLE FOLLOWING THE SURGERY. CONCOMITANT PRODUCTS: AIMING ARM FOR RETROGRADE STANDARD LOCKING (PART 03.010.050, LOT UNKNOWN, QUANTITY 1), CANNULATED CONNECTING SCREW FOR STANDARD INSERTION HANDLE (PART 03.010.444, LOT UNKNOWN, QUANTITY 1), AND A TIBIAL NAIL (PART/LOT UNKNOWN, QUANTITY 1). THIS REPORT IS FOR A 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 80MM F/IM NAIL-STER. THIS IS REPORT 3 OF 3 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 7503265 ↗