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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER SURGICAL, INC. HANDPIECE, ELECTRIC DERMATOME
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ZIMMER SURGICAL, INC. HANDPIECE, ELECTRIC DERMATOME Back to Search Results
Model Number N/A
Device Problem Failure to Cut (2587)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/10/2020
Event Type  malfunction  
Manufacturer Narrative
This event has been recorded by zimmer biomet under cmp-(b)(4).Evaluation and investigation is in process.Once the investigation is complete, a supplemental medwatch will be filed.
 
Event Description
It was reported that the dermatome was in need of repair for not able to properly mesh.The event occurred during surgery.There was no harm and no delay reported.No adverse events were reported as a result of this malfunction.
 
Event Description
Reported in error, device did not cause or contribute to the event since there was no problem found with the device.
 
Manufacturer Narrative
Reported in error, device did not cause or contribute to the event since there was no problem found with the device.
 
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Brand Name
HANDPIECE, ELECTRIC DERMATOME
Type of Device
DERMATOME
Manufacturer (Section D)
ZIMMER SURGICAL, INC.
200 west ohio avenue
dover OH 44622
MDR Report Key9664867
MDR Text Key195280005
Report Number0001526350-2020-00120
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 company representative,foreig
Type of Report Initial,Followup
Report Date 02/04/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/04/2020
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
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/20/2020
Was the Report Sent to FDA? No
Date Manufacturer Received03/27/2020
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A
Patient Sequence Number1
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