Natural Nail® 00-2490-032-44Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00889024063532), received between Oct 29, 2020 and Jan 12, 2026 — classified as 2 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Fracture” (10 reports).

5 other recalls cover devices cleared under the same FDA submission (K091566); 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 12, 2026Fracture; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING DRILLING FOR A CEPHALOMEDULLARY NAIL LAG SCREW OVER A 3.2 MM PIN, THE LAG SCREW DRILL BECAME CAUGHT WITHIN THE DRILL CANNULA AND THE GOLD TIP FRACTURED INTO MULTIPLE PIECES. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24037114 ↗
• MalfunctionMay 21, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING A PROCEDURE, THE LAG SCREW REAMER TIP BROKE WHILE REAMING. NO PATIENT CONSEQUENCES WERE REPORTED AS A RESULT OF THE EVENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22060482 ↗
• MalfunctionApr 28, 2025Fracture; Fracture

  IT WAS REPORTED THAT THE TIP OF THE REAMER WAS FRACTURED DURING A PROCEDURE BUT WAS SUCCESSFULLY REMOVED FROM THE PATIENT¿S FEMUR. ANOTHER REAMER WAS USED TO COMPLETE THE CASE. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21917675 ↗
• MalfunctionJan 14, 2025Fracture; Fracture

  NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21147775 ↗
• InjuryMar 20, 2024Fracture; Fracture

  IT WAS REPORTED THAT THE SURGEON USED THE LONG DRILL BIT ON THE PATIENT AND THE DRILL BIT FRACTURED ON 2 OCCASIONS DURING CEPHALIC AIMING. ONE PART OF THE DRILL BIT WAS LEFT IN THE PATIENT BECAUSE IT WAS IMPOSSIBLE TO FIND IT, THIS HAPPENED THE SECOND TIME IT FRACTURED. THERE WAS A DELAY OF 60 MINUTES AND THE SURGEON FOLLOWED THE PROPER SURGICAL TECHNIQUE. NO ADDITIONAL SURGERY NEEDED. NO FURTHER INFORMATION WAS KNOWN.

  Patient problems: Foreign Body In Patient

  MAUDE report 18947289 ↗
• InjuryMar 20, 2024Fracture; Fracture

  IT WAS REPORTED THAT THE SURGEON USED THE LONG DRILL BIT ON THE PATIENT AND THE DRILL BIT FRACTURED ON 2 OCCASIONS DURING CEPHALIC AIMING. ONE PART OF THE DRILL BIT WAS LEFT IN THE PATIENT BECAUSE IT WAS IMPOSSIBLE TO FIND IT, THIS HAPPENED THE SECOND TIME IT FRACTURED. THERE WAS A DELAY OF 60 MINUTES AND THE SURGEON FOLLOWED THE PROPER SURGICAL TECHNIQUE. NO ADDITIONAL SURGERY NEEDED. NO FURTHER INFORMATION WAS KNOWN.

  Patient problems: Foreign Body In Patient

  MAUDE report 18947287 ↗
• MalfunctionOct 11, 2023Fracture; Fracture

  NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17911919 ↗
• MalfunctionApr 11, 2023Fracture; Fracture

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16714449 ↗
• MalfunctionMar 10, 2022Fracture; Material Twisted/Bent; Fracture; Material Twisted/Bent

  IT WAS REPORTED DURING THE SURGERY, THE DISTAL PART OF THE REAMER BROKE. ALL PIECES WERE FOUND. NO PIECE REMAIN INTO THE PATIENT BODY. THE CARBON GUIDE MAY HAVE BEEN BENT WHILE INTRODUCING THE GUIDE WIRE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13719339 ↗
• MalfunctionOct 29, 2020Fracture; Fracture

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10757505 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K091566. One submission often covers many models, so check the product and lot details in each record.

• Z-1793-2021 · May 7, 2021 · Terminated
  Zimmer Natural Nail- ZNN Cephalomedullary Short Nail 11.5 mm X 21.5 cm 130 CCD Left Ti-6Al-4V Alloy-is intended for temporary fracture fixation and stabilization of the bone Item
• Z-1792-2021 · May 7, 2021 · Terminated
  Zimmer Natural Nail -ZNN Cephalomedullary Short Nail 11.5 mm X 21.5 cm 125 CCD Left Ti-6Al-4V Alloy- intended for temporary fracture fixation and stabilization of the bone Item Nu
• Z-0337-2020 · Oct 10, 2019 · Terminated
  Cephalomedullary Nail (CMN), Various sizes, Item Nos. 47249318009 47249318010 47249318011 47249318013 47249318014 47249318109 47249318110 47249318111 47249318113 472493181
• Z-0119-2016 · Sep 3, 2015 · Terminated
  Zimmer Natural Nail CM Long. Intramedullary Fixation Rod. The Zimmer Natural Nail System is intended for temporary fracture fixation and stabilization of the bone.
• Z-0824-2011 · Oct 29, 2010 · Terminated
  Zimmer Natural Nail System Cephalomedullary Lag Screw Inserter Long, Catalog 00-2490-003-50, Zimmer, Warsaw, IN. A reusable surgical instrument used for the insertion of a Lag Scr