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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 Intermittent Loss of Power (4016)
Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/08/2021
Event Type  malfunction  
Manufacturer Narrative
(b)(4).Once the investigation is complete, a follow up/final report will be submitted.
 
Event Description
It was reported that during surgery the device starts and stops.No harm or injury reported.A delay of unknown length of time occurred.No adverse events were reported as a result of this malfunction.
 
Manufacturer Narrative
This event has been recorded by zimmer biomet under (b)(4).This medwatch is being filed to relay additional information.The following sections were updated/corrected: b4, b5, d8, d9, g3, g6, h2, h3, h6, h8, h10.Review of the most recent repair record determined the device would not power on, the control bar was not flush with master blade, the calibration was not in limits at all readings, and the device had chips and scratches; however, the repair was not completed because the customer declined aged repair.Device is used for treatment.A definitive root cause cannot be determined.The event is confirmed.
 
Event Description
There is no additional information.
 
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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 Key11266211
MDR Text Key229869358
Report Number0001526350-2021-00119
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 07/13/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
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 Manufacturer04/14/2021
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 01/11/2021
Initial Date FDA Received02/02/2021
Supplement Dates Manufacturer Received07/13/2021
Supplement Dates FDA Received07/13/2021
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A
Patient Sequence Number1
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