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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
Catalog Number 00882100100
Device Problem Power Problem (3010)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
This event has been recorded by zimmer biomet under cmp-(b)(4).Once the investigation is complete, a follow up/final report will be submitted.
 
Event Description
It has been reported during testing the device is running slow, running slower than normal.Event occurred during testing.No harm reported.No adverse events were reported as a result of this malfunction.
 
Event Description
No additional event information available.
 
Manufacturer Narrative
(b)(4).Upon receipt of additional information, it has been determined that this device did not cause or contribute serious injury and has not been previously reported as a serious injury.The initial report was forwarded in error and should be voided.
 
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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 Key9489975
MDR Text Key197311099
Report Number0001526350-2019-01171
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 user facility
Type of Report Initial,Followup
Report Date 03/10/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/18/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number00882100100
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/05/2019
Was the Report Sent to FDA? No
Date Manufacturer Received03/05/2020
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A
Patient Sequence Number1
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