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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER SURGICAL, INC. ZIMMER ELECTRIC DERMATOME HP
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ZIMMER SURGICAL, INC. ZIMMER ELECTRIC DERMATOME HP Back to Search Results
Model Number N/A
Device Problem Intermittent Loss of Power (4016)
Patient Problem No Patient Involvement (2645)
Event Date 07/13/2020
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.(b)(6).
 
Event Description
It was reported that the dermatome loses power during the operation, though there was no patient involvement.No adverse events were reported as a result of this malfunction.
 
Event Description
There is no additional information.
 
Manufacturer Narrative
This event has been recorded by zimmer biomet under (b)(4).Review of the most recent repair record determined the motor speed was low.The motor was replaced and resolved the reported issue.Device is used for treatment.A definitive root cause cannot be determined.The event is confirmed.
 
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Brand Name
ZIMMER ELECTRIC DERMATOME HP
Type of Device
DERMATOME
Manufacturer (Section D)
ZIMMER SURGICAL, INC.
200 west ohio avenue
dover OH 44622
MDR Report Key10303918
MDR Text Key200420767
Report Number0001526350-2020-00624
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 foreign,health professional,u
Type of Report Initial,Followup
Report Date 11/05/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/21/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberN/A
Device Catalogue Number00882100100
Device Lot Number61197715
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/13/2020
Was the Report Sent to FDA? No
Date Manufacturer Received11/04/2020
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A
Patient Sequence Number1
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