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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER SURGICAL, INC. ZIMMER AIR DERMATOME

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ZIMMER SURGICAL, INC. ZIMMER AIR DERMATOME Back to Search Results
Model Number N/A
Device Problem Failure to Cut (2587)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/01/2022
Event Type  malfunction  
Manufacturer Narrative
This incident has been recorded under (b)(4).Once investigation is completed a final/supplemental report will be submitted.
 
Event Description
It was reported that during testing the device doesn't cut, but butchers' skin.There was no harm reported as event was during testing no surgical delay occurred.No adverse event was reported as it relates to this event.Diligence is completed an no further information is available.
 
Event Description
No additional event information available.
 
Manufacturer Narrative
This event has been recorded by zimmer biomet under (b)(4).This medwatch is being filed to relay additional information.Review of the most recent repair record identified no repairs related to the reported event.Review of the device history record identified no deviations or anomalies during manufacturing related to the reported event.A definitive root cause cannot be determined.The event cannot be confirmed.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
 
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Brand Name
ZIMMER AIR DERMATOME
Type of Device
DERMATOME
Manufacturer (Section D)
ZIMMER SURGICAL, INC.
200 west ohio avenue
dover OH 44622
Manufacturer (Section G)
ZIMMER SURGICAL, INC.
200 west ohio avenue
dover OH 44622
Manufacturer Contact
jennifer rapsavage
56 e. bell drive
warsaw, IN 46582
5745260384
MDR Report Key15670511
MDR Text Key302720679
Report Number0001526350-2022-01037
Device Sequence Number1
Product Code GFD
UDI-Device Identifier00889024375901
UDI-Public(01)00889024375901(11)201203(10)64957471
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 01/25/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/25/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberN/A
Device Catalogue Number00880100100
Device Lot Number64957471
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received01/19/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/03/2020
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Removal/Correction NumberN/A
Patient Sequence Number1
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