NA 00-8851-002-06Recalls & reported problems
Zimmer Orthopaedic Surgical Products, Inc. · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 22
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 00889024376144), received between Dec 4, 2023 and May 21, 2025 — classified as 2 injuries, 20 malfunctions.
The most frequently reported specific device problem is “Gas/Air Leak” (17 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
- Gas/Air Leak17
- Failure to Power Up6
- Pressure Problem2
- Appropriate Device Problem Term/Code Not Available1
- Infusion or Flow Problem1
- Material Deformation1
Patient problems
- No Clinical Signs, Symptoms or Conditions20
- Insufficient Information6
- Skin Tears2
Recent adverse event reports
The 22 most recent of 22 reports, in the reporter's own words as published by the FDA.
InjuryMay 21, 2025Pressure Problem; Pressure Problem
THERE IS NO ADDITIONAL INFORMATION REGARDING THE EVENT.
Patient problems: Skin Tears
MAUDE report 22061439 ↗InjuryApr 16, 2025Pressure Problem; Pressure Problem
THERE IS NO ADDITIONAL INFORMATION REGARDING THE EVENT.
Patient problems: Skin Tears
MAUDE report 21847797 ↗MalfunctionApr 10, 2025Gas/Air Leak; Gas/Air Leak
IT WAS REPORTED THAT DURING TESTING, THE HOSE WAS LEAKING AIR. THERE WAS NO PATIENT INVOLVEMENT. DUE DILIGENCE IS COMPLETE. NO ADDITIONAL INFORMATION IS AVAILABLE. THERE WAS NO ADVERSE EVENT ASSOCIATED WITH THIS MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21813954 ↗MalfunctionApr 9, 2025Gas/Air Leak; Gas/Air Leak
IT WAS REPORTED THAT THE DEVICE IS LEAKING AIR. THE HOSE WAS NOT USED IN THEATRES. IT WAS TESTED BY THEATRES AS SOON AS IT ARRIVED AND WAS FOUND TO BE FAULTY. THERE IS NO HARM OR DELAY REPORTED. DUE DILIGENCE IS COMPLETE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21808667 ↗MalfunctionNov 21, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT OUTSIDE OF SURGERY THE AIR HOSE IS NOT WORKING AND NEEDS REPAIRED. THERE WAS NO PATIENT INVOLVEMENT. DUE DILIGENCE IS COMPLETE AND THERE IS NO ADDITIONAL INFORMATION AVAILABLE. AT DEVICE EVALUATION IT WAS NOTED THE HOSE WAS LEAKING AIR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20748584 ↗MalfunctionSep 25, 2024Material Deformation; Material Deformation
IT WAS REPORTED THAT DURING SURGERY THERE WAS A HOLE IN THE AIR HOSE. THERE WAS NO PATIENT IMPACT AND THERE WAS A DELAY OF 5-10 MINUTES. AN ALTERNATE DEVICE WAS UTILIZED TO COMPLETE THE PROCEDURE. DURING PRODUCT EVALUATION IT WAS FOUND THAT THE HOSE WAS HISSING AND LEAKING AIR. DUE DILIGENCE IS COMPLETE AND THERE IS NO ADDITIONAL INFORMATION AVAILABLE. THERE WAS NO ADVERSE EVENT ASSOCIATED WITH THE MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20307077 ↗MalfunctionSep 20, 2024Gas/Air Leak; Gas/Air Leak
NO ADDITIONAL EVENT INFORMATION AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20266324 ↗MalfunctionSep 20, 2024Gas/Air Leak; Gas/Air Leak
THERE IS NO ADDITIONAL INFORMATION AVAILABLE REGARDING THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20266090 ↗MalfunctionAug 29, 2024Failure to Power Up; Gas/Air Leak; Failure to Power Up; Gas/Air Leak
IT WAS REPORTED THAT DURING AN UNKNOWN TIME THE HOSE HAD A FAILURE AS AIR HOSE LEAKED AIR AND INTERMITTENTLY FAILED TO POWER THE DERMATOME. THERE IS NO HARM OR DELAY REPORTED. DUE DILIGENCE IS COMPLETE AS THERE IS NO ADDITIONAL INFORMATION AVAILABLE.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 20102376 ↗MalfunctionAug 29, 2024Failure to Power Up; Gas/Air Leak; Failure to Power Up; Gas/Air Leak
IT WAS REPORTED THAT DURING AN UNKNOWN TIME THE HOSE HAD A FAILURE AS AIR HOSE LEAKED AIR AND INTERMITTENTLY FAILED TO POWER THE DERMATOME. THERE IS NO HARM OR DELAY REPORTED. DUE DILIGENCE IS COMPLETE AS THERE IS NO ADDITIONAL INFORMATION AVAILABLE.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 20102197 ↗MalfunctionAug 29, 2024Failure to Power Up; Gas/Air Leak; Failure to Power Up; Gas/Air Leak
THERE IS NO ADDITIONAL EVENT INFORMATION AVAILABLE.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 20101973 ↗MalfunctionAug 29, 2024Failure to Power Up; Gas/Air Leak; Failure to Power Up; Gas/Air Leak
IT WAS REPORTED THAT DURING AN UNKNOWN TIMING THE HOSE FAILURES AS AIR HOSES LEAK AIR AND INTERMITTENTLY FAIL TO POWER THE DERMATOMES. THERE IS NO HARM OR DELAY REPORTED. DUE DILIGENCE IS COMPLETE AS THERE IS NO ADDITIONAL INFORMATION AVAILABLE.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 20101280 ↗MalfunctionAug 29, 2024Failure to Power Up; Gas/Air Leak; Failure to Power Up; Gas/Air Leak
THERE IS NO ADDITIONAL EVENT INFORMATION AVAILABLE.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 20100823 ↗MalfunctionAug 29, 2024Failure to Power Up; Gas/Air Leak; Failure to Power Up; Gas/Air Leak
THERE IS NO ADDITIONAL EVENT INFORMATION AVAILABLE.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 20100676 ↗MalfunctionJul 15, 2024Infusion or Flow Problem; Infusion or Flow Problem
IT WAS REPORTED THAT DURING SURGERY, THE DERMA HOSE WAS NOT ALLOWING AIR TO PASS THROUGH. THERE WAS NO PATIENT HARM OR SURGICAL DELAY REPORTED. DURING DEVICE EVALUATION IT WAS DISCOVERED A LEAK COULD BE HEARD AND FELT AT THE CONNECTION OF THE HOSE AND HANDPIECE. DUE DILIGENCE IS COMPLETE, NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19746002 ↗MalfunctionMay 6, 2024Gas/Air Leak; Gas/Air Leak
THERE IS NO ADDITIONAL EVENT INFORMATION AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19248131 ↗MalfunctionMay 6, 2024Gas/Air Leak; Gas/Air Leak
IT WAS REPORTED OUTSIDE OF SURGERY THAT THE AIR HOSE WAS AUDIBLY LEAKING AND THEREFORE WOULDNT POWER DERMATOME. THERE WAS NO PATIENT INVOLVEMENT. DUE DILIGENCE IS COMPLETE AS MULTIPLE ATTEMPTS WERE MADE; HOWEVER, NO FURTHER INFORMATION IS AVAILABLE. AS NO ADDITIONAL INFORMATION OR PRODUCT IS AVAILABLE, WE ARE UNABLE TO PROVIDE FURTHER INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19248115 ↗MalfunctionMay 1, 2024Gas/Air Leak; Gas/Air Leak
NO ADDITIONAL EVENT INFORMATION AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19220064 ↗MalfunctionMar 20, 2024Gas/Air Leak; Gas/Air Leak
IT WAS REPORTED THAT OUTSIDE OF SURGERY, THERE WAS A LEAK FROM THE A/R VALVE AT THE MOTOR CONNECTION. THERE WAS NO PATIENT INVOLVEMENT OR IMPACT. DUE DILIGENCE IS IN PROCESS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18940416 ↗MalfunctionJan 3, 2024Gas/Air Leak; Gas/Air Leak
IT WAS REPORTED THAT BEFORE SURGERY ON (B)(6) 2023, THERE IS A LEAK ON THE DERMATOME HOSE AT THE COUPLING PART. A SMALL O-RING DOES NOT MAKE THE SEAL. THERE WAS NO PATIENT INVOLVEMENT, IMPACT, OR HARM REPORTED. DUE DILIGENCE INFORMATION IN PROCESS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18435262 ↗MalfunctionDec 4, 2023Gas/Air Leak; Gas/Air Leak
IT WAS REPORTED THAT BEFORE SURGERY THAT THERE WAS A LEAKAGE AT THE COUPLING PORTION OF THE HOSE. THE SMALL O-RING DID NOT MAKE THE SEAL. THERE WAS NO HARM OR INJURY TO THE PATIENT AND NO REPORTED DELAY. DUE DILIGENCE IS COMPLETE. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18256433 ↗MalfunctionDec 4, 2023Gas/Air Leak; Gas/Air Leak
NO ADDITIONAL INFORMATION IS AVAILABLE REGARDING THE INCIDENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18256428 ↗
Other DERMATOME devices
- Dermatome 00-8801-001-00Zimmer Orthopaedic Surgical Products, Inc. · Dermatome1 recall631 reports
- Dermatome 00-8821-001-00Zimmer Orthopaedic Surgical Products, Inc. · Dermatome614 reports
- Dermatome 88710100Zimmer Orthopaedic Surgical Products, Inc. · DERMATOME242 reports
- Dermatome 00-8800-000-10Zimmer Orthopaedic Surgical Products, Inc. · Dermatome1 recall109 reports
- ACCULAN 3TI GA670Aesculap AG · Dermatome6 reports
- Air Dermatome 00-8801-002-00Zimmer Orthopaedic Surgical Products, Inc. · Dermatome5 reports
- NA 00-8851-002-05Zimmer Orthopaedic Surgical Products, Inc. · DERMATOME3 reports
- NA 00-8851-002-03Zimmer Orthopaedic Surgical Products, Inc. · DERMATOME3 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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