Nexel® 00-8401-080-00Recalls & reported problems
Zimmer, Inc. · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 9
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00889024272200), received between Dec 4, 2020 and Dec 29, 2025 — classified as 2 injuries, 7 malfunctions.
The most frequently reported specific device problem is “Fracture” (8 reports).
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.
Reports received per month
Most reported problems
Device problems
- Fracture8
- Tear, Rip or Hole in Device Packaging1
Patient problems
- No Clinical Signs, Symptoms or Conditions5
- Foreign Body In Patient3
- No Patient Involvement1
Recent adverse event reports
The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 29, 2025Fracture; Fracture
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23906397 ↗MalfunctionNov 24, 2025Fracture; Fracture
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23632997 ↗MalfunctionOct 23, 2025Fracture; Fracture
ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Foreign Body In Patient
MAUDE report 23373522 ↗InjurySep 18, 2025Fracture; Fracture
IT WAS REPORTED THAT DURING SURGERY, THE TIP OF THE SCREWDRIVER FRACTURED WHEN INSERTING THE SCREW. THE SURGEON SEARCHED FOR THE FRAGMENT BUT WAS UNABLE TO FIND IT, LEAVING IT INSIDE THE PATIENT'S BODY. THERE ARE CURRENTLY NO PLANS TO PERFORM SURGERY TO REMOVE THE BROKEN PIECE. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.
Patient problems: Foreign Body In Patient
MAUDE report 23085200 ↗InjuryAug 29, 2025Fracture; Fracture
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Foreign Body In Patient
MAUDE report 22922911 ↗MalfunctionAug 26, 2025Fracture; Fracture
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22897495 ↗MalfunctionAug 21, 2025Fracture; Fracture
IT WAS REPORTED THAT DURING A PROCEDURE, THE TIP OF THE TORQUE DRIVER FRACTURED WHEN INSERTING THE HUMERAL SCREW. THE BROKEN PIECE WAS RETRIEVED FROM THE PATIENT, AND THE SURGERY WAS COMPLETED USING A NEW DRIVER. NO DELAYS OR HARMS IN THE PROCEDURE OCCURRED THAT WAS RELATED TO THE EVENT. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22862591 ↗MalfunctionOct 30, 2023Fracture; Fracture
IT WAS REPORTED THAT DURING A PROCEDURE APPROXIMATELY THREE (3) WEEKS AGO, THE TIP OF THE TORQUE SCREWDRIVER FRACTURED AT THE START OF USE WITH MINIMAL FORCE EXERTED. ANOTHER DRIVER WAS USED TO COMPLETE THE SURGERY. NO PATIENT CONSEQUENCES WERE REPORTED AS A RESULT OF THE MALFUNCTION. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18029673 ↗MalfunctionDec 4, 2020Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Patient Involvement
MAUDE report 10949078 ↗
Other PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED devices
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- Arcos Modular Revision Hip System 11-301302Biomet Orthopedics, LLC · PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED1 recall5 reports
- Arcos Modular Revision Hip System 11-301343Biomet Orthopedics, LLC · PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED1 recall1 report
- ARROW IPN037140Teleflex Incorporated · PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED1 recall0 reports
- Comprehensive® SRS / Discovery® 211251Biomet Orthopedics, LLC · PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED1 recall0 reports
- Arcos Modular Revision Hip System 11-301325Biomet Orthopedics, LLC · PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED1 recall0 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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