Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER SURGICAL, INC. ZIMMER AIR DERMATOME
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ZIMMER SURGICAL, INC. ZIMMER AIR DERMATOME Back to Search Results
Model Number N/A
Device Problem Intermittent Loss of Power (4016)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/11/2020
Event Type  malfunction  
Manufacturer Narrative
This event has been recorded by zimmer biomet under (b)(4).Once an evaluation of this device is completed, a follow-up/final report will be submitted.
 
Event Description
It was reported that the dermatome would work for a few seconds intermittently.Event occurred during surgery, however no graft was attempted once the issues were noticed.No adverse events were reported as a result of this malfunction.
 
Manufacturer Narrative
This event has been recorded by zimmer biomet under (b)(4).Review of the most recent repair record identified no repairs related to the reported event.It was noted that the device has not been returned for recommended annual pm since it was manufactured.Device is used for treatment.A definitive root cause cannot be determined.The event cannot be confirmed.
 
Event Description
No additional event information available.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
ZIMMER AIR DERMATOME
Type of Device
DERMATOME
Manufacturer (Section D)
ZIMMER SURGICAL, INC.
200 west ohio avenue
dover OH 44622
MDR Report Key10905461
MDR Text Key218517616
Report Number0001526350-2020-01000
Device Sequence Number1
Product Code GFD
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Type of Report Initial,Followup
Report Date 02/10/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/25/2020
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 Number63072285
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/30/2020
Was the Report Sent to FDA? No
Date Manufacturer Received02/09/2021
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A
Patient Sequence Number1
-
-