NA 04.005.550SRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982086198), received between May 10, 2018 and May 27, 2019 — classified as 3 injuries.

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 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryMay 27, 2019No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT AN OPEN REDUCTION INTERNAL FIXATION (ORIF) AND HARDWARE REMOVAL DUE TO IMPLANTS NEED TO COME OUT FOR STAGING AND CONVERTED TO THE TOTAL HIP PROCEDURE. THE FOLLOWING DEVICES WERE INITIALLY IMPLANTED ON AN UNKNOWN DATE; ONE (1) RETROGRADE FEMORAL NAIL, ONE (1) 5.0MM/60MM TITANIUM LOCKING SCREW, ONE (1) 5.0MM/28MM TITANIUM LOCKING SCREW, UNKNOWN DYNAMIC HIP AND CONDYLAR SCREW SYSTEM (DHS/DCS) PLATE, AND ONE (1) DHS/DCS LAG SCREW. NOTHING WAS BROKEN AND THERE WAS NO ISSUE ON THE DEVICES REMOVED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SURGICAL DELAY. PATIENT OUTCOME IS UNKNOWN. THIS REPORT IS FOR ONE (1) 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 60MM F/IM NAIL-STER. THIS IS REPORT 5 OF 5 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 8644085 ↗
• InjuryMay 27, 2019No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT AN OPEN REDUCTION INTERNAL FIXATION (ORIF) AND HARDWARE REMOVAL DUE TO IMPLANTS NEED TO COME OUT FOR STAGING AND CONVERTED TO THE TOTAL HIP PROCEDURE. THE FOLLOWING DEVICES WERE INITIALLY IMPLANTED ON AN UNKNOWN DATE; ONE (1) RETROGRADE FEMORAL NAIL, ONE (1) 5.0MM/60MM TITANIUM LOCKING SCREW, ONE (1) 5.0MM/28MM TITANIUM LOCKING SCREW, UNKNOWN DYNAMIC HIP AND CONDYLAR SCREW SYSTEM (DHS/DCS) PLATE, AND ONE (1) DHS/DCS LAG SCREW. NOTHING WAS BROKEN AND THERE WAS NO ISSUE ON THE DEVICES REMOVED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SURGICAL DELAY. PATIENT OUTCOME IS UNKNOWN. THIS REPORT IS FOR ONE (1) 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 60MM F/IM NAIL-STER. THIS IS REPORT 4 OF 5 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 8644083 ↗
• 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 5.0 MM TI LOCKING SCREW W/T25 STARDRIVE 60 MM F/IM NAIL-STER. THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 7503257 ↗