NA 04.045.870SRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10886982296054), received between Aug 29, 2025 and Jun 16, 2026 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (4 reports).

2 other recalls cover devices cleared under the same FDA submission (K160167); 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 16, 2026No Apparent Adverse Event

  IT WAS REPORTED THAT A TFNA NAIL BROKE POSTOPERATIVELY. THE EVENT RESULTED IN HARDWARE REMOVAL AND REVISION SURGERY DUE TO THE BREAKAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25519484 ↗
• MalfunctionMay 19, 2026Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT UNDERWENT ORIF VIA TFNA FOR FEMORAL TROCHANTERIC FRACTURE IN THE SURGERY, THE PROCEDURE PROCEEDED AS USUAL, BUT WHEN IT CAME TIME TO INSERT THE FINAL END CAP, IT WOULDN'T GO IN, REQUIRING AN EXTRA 40 MINUTES. IT WAS CONFIRMED THAT THE SET SCREW WAS DESCENDING AT THE STEP BETWEEN THE STRAIGHT AND BELLOWS SECTIONS OF THE DRIVER. ADDITIONAL INTERNAL ROTATION, FRONT AND SIDE CHECKS, AND HAND UP AND DOWN MOVEMENTS WERE PERFORMED, BUT THE PRODUCT STILL WOULDN'T GO IN. IT GOT STUCK SEVERAL TIMES AT AN ANGLE. UPON EXAMINING THE THREADED PART OF THE END CAP, A LONG, THIN METAL FRAGMENT, PRESUMABLY FROM FRICTION, WAS FOUND. ALSO, THERE WERE SIGNS OF SLIGHT CRUSHING IN SOME PARTS OF THE THREAD DUE TO REPEATED INSERTION AND REMOVAL. A NEW 5MM END CAP EXTENSION WAS BROUGHT OUT AND TRIED WITH THAT, BUT THAT ALSO WOULDN'T GO IN. ULTIMATELY, THE PROCEDURE WAS COMPLETED WITHOUT INSERTING THE END CAP. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH 40 MINUTES SURGICAL DELAY. THE SURGEON COMMENTED THAT IT'S POSSIBLE THE SCREW WAS BENT DURING INSERTION, CAUSING THE THREADS TO JAM AND RESULTING IN DAMAGE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25221916 ↗
• MalfunctionFeb 19, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2026, THE PATIENT UNDERWENT SURGERY WITH TFNA LONG NAIL. WHEN INSERTING THE END CAP, IT ONLY WENT IN PARTWAY AND DID NOT GO ALL THE WAY DOWN. IT WAS POINTED OUT THAT THERE WAS A POSSIBILITY THAT THE LOCKING MECHANISM WAS NOT FULLY ADVANCED TO A PROPER POSITION. THE ATTENDING PHYSICIAN DETERMINED THE WERE NO ISSUES BECAUSE THE SURGEON WAS ABLE TO CONFIRM THAT THE END CAP WAS TIGHTLY FASTENED, AND ALSO NOTED THAT THE NAIL WAS INSERTED AS A PREVENTATIVE MEASURE AND THERE WERE NO FRACTURES, SO THE HEAD ELEMENT WOULD NOT SLIDE, AND THEREFORE IT WAS NOT A PROBLEM EVEN IF THE LOCKING MECHANISM HAD NOT BEEN ADVANCED TO A PROPER POSITION. THE PROCEDURE WAS COMPLETED WITH THE END CAP PROTRUDING A FEW MILLIMETERS FROM THE PROXIMAL END. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN A 30-MINUTE DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24390165 ↗
• MalfunctionDec 30, 2025Device-Device Incompatibility; Material Integrity Problem; Device-Device Incompatibility; Material Integrity Problem

  IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT UNDERWENT AN ORIF FOR FEMORAL TROCHANTERIC FRACTURE WITH THE END CAP. A TFNA OPERATION WAS PERFORMED, BUT THE END CAP COULD NOT BE CONNECTED TO THE XL40 DRIVER, SO THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY WITH USING ANOTHER END CAP. AFTER THE SURGERY, AN INSPECTION OF THE END CAP REVEALED THAT THE SHAPE OF THE HEAD INSIDE WAS DIFFERENT FROM THE OTHER END CAPS. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23920758 ↗
• MalfunctionAug 29, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT UNDERWENT AN TFNA SURGERY WITH THE ENDCAPS. AFTER THE TFNA WAS FIXED, THE SURGEON REMOVED THE DEVICE AND ATTEMPTED TO INSERT THE ENDCAP (0MM), BUT IT BECAME STUCK MIDWAY AND COULD NOT BE INSERTED. THE SALES REP THOUGHT IT MIGHT BE POSSIBLE THAT THE SET SCREW HAD NOT YET BEEN LOWERED ALL THE WAY, PREVENTING THE ENDCAP FROM FULLY INSERTING. THE SURGEON TRIED TO RETIGHTEN THE SET SCREW, BUT THE ENDCAP REMAINED STUCK IN THE SAME POSITION. ANOTHER POSSIBILITY WAS THAT A PIECE OF FLESH OR BONE HAD GOTTEN INSIDE THE NAIL AND WAS INTERFERING WITH THE ENDCAP'S THREADS. AFTER THOROUGH CLEANING, THE SURGEON ATTEMPTED TO INSERT THE ENDCAP AGAIN, BUT IT DID NOT GO IN. THE THREADS ON THE 0MM END CAP APPEARED TO BE SLIGHTLY WORN DOWN, SO THE SURGEON DECIDED TO ISSUE A NEW END CAP (5MM) AND ATTEMPT TO INSERT IT, BUT IT ONCE AGAIN BECAME STUCK IN THE SAME POSITION AND COULD NOT BE INSERTED FULLY. AFTER SEVERAL ATTEMPTS, THE SURGEON WAS UNABLE TO INSERT IT NO MATTER WHAT HE DID, SO THE SURGEON DECIDED TO CLOSE THE WOUND WITHOUT THE ENDCAP. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY. IN THE SURGEON'S OPINION, BECAUSE THE BONE WAS SIGNIFICANTL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22922140 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K160167. One submission often covers many models, so check the product and lot details in each record.

• Z-1240-2024 · Jan 24, 2024 · Open, Classified
  TFNA Femoral Nail 11mm, right, 130, L 235mm-Intended for temporary fixation and stabilization of proximal femur fractures. Part Number: 04.037.144S
• Z-1239-2024 · Jan 24, 2024 · Open, Classified
  TFNA Femoral Nail 9mm, right, 130, L 235mm-Intended for temporary fixation and stabilization of proximal femur fractures. Part Number: 04.037.944S