NA 04.003.025SRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982081544), received between Feb 28, 2019 and Mar 18, 2019 — classified as 2 injuries.

The most frequently reported specific device problem is “Device-Device Incompatibility” (2 reports).

2 other recalls cover devices cleared under the same FDA submission (K040336, K172157); they may or may not involve this specific model.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryMar 18, 2019Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING AN ORTHOPEDIC SURGERY ON (B)(6) 2019, THE SURGEON WAS USING THE LATERAL ENTRY FEMORAL RECON NAIL (LEFN) SYSTEM AND FOLLOWED THE PROTOCOL FOR INSERTING THE TWO (2) RECON SCREWS. AFTER INSERTION THROUGH THE DRILL/PROTECTION SLEEVES WITHIN THE AIMING ARM, THE TWO (2) RECON SCREWS WERE OUTSIDE OF THE NAIL (ANTERIOR TO THE NAIL IMPLANT), IN THE FEMORAL NECK AND HEAD. THE SURGEON REMOVED THE TWO (2) SCREWS AND HAD TO FREEHAND THE SCREWS INTO THE RECON SLOTS OF THE NAIL. THERE WAS A SURGICAL DELAY OF THIRTY (30) MINUTES. PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCE. CONCOMITANT DEVICE REPORTED: CANNULATED CONNECTING SCREW FOR STANDARD INSERTION HANDLE (PART # 03.010.044, LOT # UQ55557, QUANTITY # 1); STANDARD INSERTION HANDLE (PART # 03.010.045, LOT # 3040015, QUANTITY # 1); PROTECTION SLEEVE FOR RECON LOCKING (PART # 03.010.075, LOT # 37452A, QUANTITY # 2); WIRE GUIDE FOR RECON LOCKING (PART 03.010.076 , LOT # 37453, QUANTITY # 2); RECON LOCKING AIMING ARM FOR LATERAL ENTRY FEMORAL NAILS-EX (PART # 03.010.048, LOT # 5621601, QUANTITY # 1); TITANIUM LATERAL ENTRY FEMORAL RECON NAIL-EX/360MM/LT-STERILE (PART # 04.003.253S, LOT # 7498154

  Patient problems: No Code Available

  MAUDE report 8429140 ↗
• InjuryFeb 28, 2019Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING AN ORTHOPEDIC SURGERY ON (B)(6) 2019, THE SURGEON WAS USING THE LATERAL ENTRY FEMORAL RECON NAIL (LEFN) SYSTEM AND FOLLOWED THE PROTOCOL FOR INSERTING THE TWO (2) RECON SCREWS. AFTER INSERTION THROUGH THE DRILL/PROTECTION SLEEVES WITHIN THE AIMING ARM, THE TWO (2) RECON SCREWS WERE OUTSIDE OF THE NAIL (ANTERIOR TO THE NAIL IMPLANT), IN THE FEMORAL NECK AND HEAD. THE SURGEON REMOVED THE TWO (2) SCREWS AND HAD TO FREEHAND THE SCREWS INTO THE RECON SLOTS OF THE NAIL. THERE WAS A SURGICAL DELAY OF THIRTY (30) MINUTES. PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCE. CONCOMITANT DEVICE REPORTED: CANNULATED CONNECTING SCREW FOR STANDARD INSERTION HANDLE (PART # 03.010.044, LOT # UQ55557, QUANTITY # 1); STANDARD INSERTION HANDLE (PART # 03.010.045, LOT # 3040015, QUANTITY # 1); PROTECTION SLEEVE FOR RECON LOCKING (PART # 03.010.075, LOT # 37452A, QUANTITY # 2); WIRE GUIDE FOR RECON LOCKING (PART 03.010.076 , LOT # 37453, QUANTITY # 2); RECON LOCKING AIMING ARM FOR LATERAL ENTRY FEMORAL NAILS-EX (PART # 03.010.048, LOT # 5621601, QUANTITY # 1); TITANIUM LATERAL ENTRY FEMORAL RECON NAIL-EX/360MM/LT-STERILE (PART # 04.003.253S, LOT # 7498154

  Patient problems: No Code Available

  MAUDE report 8378088 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K040336, K172157. One submission often covers many models, so check the product and lot details in each record.

• Z-1915-2015 · May 27, 2015 · Terminated
  DePuy Synthes 6.5 mm Titanium Recon Screws w/T25 Stardrive (70mm, 75mm, 80mm, 85mm, 90mm, 95mm, 105mm); part of the Expert Lateral Femur Nail System and indicated to stabilize Sub
• Z-2058-2013 · Nov 2, 2012 · Terminated
  Synthes Trauma Nail System. The devices are indication for bone fixation.