Zimmer® Natural Nail™ System 00-2490-003-64Recalls & reported problems

Summary

The FDA's MAUDE database contains 54 adverse event reports that list this exact device (DI 00889024276260), received between Jul 4, 2019 and Aug 20, 2025 — classified as 31 injuries, 23 malfunctions.

The most frequently reported specific device problem is “Fracture” (51 reports).

5 other recalls cover devices cleared under the same FDA submission (K091566, K231114); 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 25 most recent of 54 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 20, 2025Fracture; Fracture

  IT WAS REPORTED THAT ONE OF THE REAMERS BROKE BUT NOBODY KNOWS WHEN. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22851114 ↗
• MalfunctionJul 16, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING AN INITIAL PROCEDURE WITH CM NAIL, WHEN THE INSTRUMENTS WERE RECEIVED THE AFTER THE CASE AND ONCE CLEANED, IT WAS NOTICED THE SCREW REAMER HAD A BROKEN TIP. NO RETAINED PRODUCT OR HARM WAS REPORTED. DILIGENCE IS COMPLETED AND NO FURTHER INFORMATION ON THE REPORTED EVENT HAS BEEN PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 22521038 ↗
• InjuryJun 19, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING AN INITIAL HIP PROCEDURE, THE TIP OF THE REAMER BROKE OFF INSIDE THE PATIENT DURING ROUTINE CM NAIL. NO HARM WAS REPORTED. DILIGENCE IS COMPLETED AND NO FURTHER INFORMATION ON THE REPORTED EVENT HAS BEEN PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 22289678 ↗
• InjuryDec 26, 2024Fracture; Fracture

  IT WAS REPORTED THAT A SCREW LAG REAMER WAS BROKEN DURING A SURGERY. INSTRUMENT BROKEN INTRAOPERATIVELY AND 2 PIECES WERE RECOVERED, HOWEVER, IT IS UNKNOWN IF THESE WERE ALL THE PIECES NOR THE HARM TO THE PATIENT. DUE DILIGENCE IS IN PROCESS AND TO DATE NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 21020000 ↗
• InjuryDec 26, 2024Fracture; Fracture

  IT WAS REPORTED THAT A SCREW LAG REAMER WAS BROKEN DURING A SURGERY. THE SURGEON DID NOT REMOVE THE NAILING GUIDE AND PIECES WERE MISSING FROM WHAT WAS RETURNED TO STERILIZATION. IT IS UNKNOWN THE HARM TO THE PATIENT. DILIGENCE IS COMPLETED AND NO FURTHER INFORMATION ON THE REPORTED EVENT HAS BEEN PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 21019993 ↗
• InjuryDec 26, 2024Fracture; Fracture

  IT WAS REPORTED THAT A SCREW LAG REAMER WAS BROKEN DURING A SURGERY. INSTRUMENT WAS NOTED BROKEN AT STERILIZATION TIME AND MISSING PIECES WERE NOT RECOVERED. IT IS UNKNOWN THE HARM TO THE PATIENT. DILIGENCE IS COMPLETED AND NO FURTHER INFORMATION ON THE REPORTED EVENT HAS BEEN PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 21019989 ↗
• MalfunctionOct 23, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING THE INITIATION OF A HIP REPLACEMENT BROKEN PARTS OF A NEW OPENED REAMER FROM THE ZNN CMN SYSTEM WERE FOUND. THERE WAS NO IMPACT TO PATIENT. DILIGENCE IS COMPLETE AND NO FURTHER INFORMATION ON THE REPORTED EVENT HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20517701 ↗
• InjurySep 24, 2024Fracture; Fracture

  DILIGENCE IS COMPLETE AND NO FURTHER INFORMATION ON THE REPORTED EVENT HAS BEEN PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 20294568 ↗
• InjurySep 24, 2024Fracture; Fracture

  DILIGENCE IS COMPLETED AND NO FURTHER INFORMATION ON THE REPORTED EVENT HAS BEEN PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 20294314 ↗
• InjurySep 24, 2024Fracture; Fracture

  DILIGENCE IS COMPLETED AND NO FURTHER INFORMATION ON THE REPORTED EVENT HAS BEEN PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 20292104 ↗
• InjurySep 19, 2024Fracture; Fracture

  IT WAS REPORTED IN A PRIMARY SURGERY THAT THE TIP OF THE LAG SCREW REAMER BROKE AND A SMALL PIECE WAS LEFT INSIDE THE PATIENT. SURGICAL DELAY. DILIGENCE IS COMPLETED AND NO FURTHER INFORMATION ON THE REPORTED EVENT HAS BEEN PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 20258117 ↗
• InjurySep 18, 2024Fracture; Fracture

  NO ADDITIONAL EVENT INFORMATION AT THIS TIME.

  Patient problems: Foreign Body In Patient

  MAUDE report 20244997 ↗
• MalfunctionSep 4, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING THE PROCEDURE THE ZNN CMN HIP SCREW DRILL BIT BROKE OFF DURING USE. ATTEMPTS HAVE BEEN MADE AND NO ADDITIONAL INFORMATION ON THE REPORTED EVENT IS REQUIRED AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20138047 ↗
• MalfunctionSep 4, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING THE PROCEDURE THE ZNN CMN HIP SCREW DRILL BIT BROKE OFF DURING USE. ATTEMPTS HAVE BEEN MADE AND NO ADDITIONAL INFORMATION ON THE REPORTED EVENT IS REQUIRED AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20138045 ↗
• InjuryAug 22, 2024Fracture; Fracture

  NO ADDITIONAL EVENT INFORMATION AT THIS TIME.

  Patient problems: Foreign Body In Patient

  MAUDE report 20039196 ↗
• InjuryJul 3, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING A PRIMARY SURGICAL PROCEDURE THE LAG SCREW REAMER TIP BROKE WHILE BEING USED AND ONE PIECE WAS LEFT INSIDE THE PATIENT, HOWEVER THERE IS NO REPORTED HARM OR INJURY TO THE PATIENT. THERE WAS APPROXIMATELY 10 MIN OF DELAY IN THE PROCEDURE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 19667706 ↗
• MalfunctionJun 19, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING A PROCEDURE A LAG SCREW REAMER BROKE AT THE TIP. SURGERY WAS DELAYED BY 10 MINUTES, HOWEVER THERE WAS NO HARM TO PATIENT. DILIGENCE IS COMPLETED AND NO FURTHER INFORMATION ON THE REPORTED EVENT IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19568501 ↗
• InjuryJun 3, 2024Fracture; Fracture

  NO ADDITIONAL INFORMATION AT THIS TIME.

  Patient problems: Foreign Body In Patient

  MAUDE report 19446431 ↗
• InjuryMay 8, 2024Fracture; Fracture

  IT WAS REPORTED IN A PRIMARY SURGERY THAT THE TIP OF THE LAG SCREW REAMER BROKE DURING THE OPERATION AND A PIECE OF THE INSTRUMENT WAS LEFT INSIDE THE PATIENT. DELAY OF 15 MINUTES. DILIGENCE HAS BEEN COMPLETED AND NO ADDITIONAL INFORMATION IS REQUIRED AT THIS TIME.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19270540 ↗
• MalfunctionMar 22, 2024Fracture; Fracture

  IT WAS REPORTED THAT THIS DEVICE FRACTURED AT THE TIP DURING A PRIMARY SURGERY. THESE INSTRUMENTS WERE USED MANY TIMES BEFORE. NO HARM TO PATIENT AND NO PIECE LEFT INSIDE THE PATIENT. DILIGENCE IS COMPLETE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18960037 ↗
• MalfunctionMar 22, 2024Fracture; Fracture

  IT WAS REPORTED THAT THIS DEVICE FRACTURED AT THE TIP DURING A PRIMARY SURGERY. THESE INSTRUMENTS WERE USED MANY TIMES BEFORE. NO HARM TO PATIENT AND NO PIECE LEFT INSIDE THE PATIENT. DILIGENCE IS COMPLETE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18960031 ↗
• InjuryMar 20, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING A PRIMARY SURGICAL PROCEDURE THE INSTRUMENT FRACTURED WHILE BEING USED, RESULTING IN A SURGERY DELAY OF 15 MINUTES. FEW PIECES WERE LEFT INSIDE THE PATIENT, BUT THERE IS NO REPORTED HARM OR INJURY TO THE PATIENT AND THE SURGERY WAS FINISHED USING THE SAME INSTRUMENT. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.

  Patient problems: Foreign Body In Patient

  MAUDE report 18941603 ↗
• InjuryMar 20, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING A PRIMARY SURGICAL PROCEDURE THE INSTRUMENT FRACTURED WHILE BEING USED. IT WAS REPORTED THERE WAS A DELAY OF 15 MINUTES. A SMALL PIECE WAS LEFT INSIDE THE PATIENT, HOWEVER THERE IS NO REPORTED HARM OR INJURY TO THE PATIENT. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION HAS BEEN RECEIVED.

  Patient problems: Foreign Body In Patient

  MAUDE report 18941319 ↗
• InjuryMar 11, 2024Fracture; Fracture

  IT WAS REPORTED THAT A LAG SCREW REAMER FOR CMN NAIL BROKE DURING PRIMARY SURGERY. A SMALL PIECE WAS LEFT AND IS STILL INSIDE THE PATIENT. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Foreign Body In Patient

  MAUDE report 18873645 ↗
• InjuryFeb 26, 2024Fracture; Fracture

  IT WAS REPORTED THAT A LAG SCREW REAMER FOR CMN NAIL BROKE. THIS WAS PRIMARY SURGERY; SURGICAL TECHNIQUE WAS FOLLOWED, AND HALF OF THE BLADE BROKE OFF. SMALL PIECE LEFT INSIDE THE PATIENT WITH NO HARM TO PATIENT. DELAY OF 15 MINUTES. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Foreign Body In Patient

  MAUDE report 18782991 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K091566, K231114. One submission often covers many models, so check the product and lot details in each record.

• 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-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-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