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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER SURGICAL, INC. DERMATOME AN HANDPIECE
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ZIMMER SURGICAL, INC. DERMATOME AN HANDPIECE Back to Search Results
Model Number N/A
Device Problem Insufficient Information (3190)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
Complaint has been recorded by zimmer biomet under (b)(4).Review of the most recent repair record determined the hose had a leak, control bar was not in the correct position, and the calibration was out and the hose, head, control bar, thickness control lever, thickness control shaft, and hose were replaced and resolved the reported issue.A definitive root cause cannot be determined.No corrective actions, preventive actions, or field actions resulted after investigation of this event.The event is confirmed.
 
Event Description
It was reported that the unit was sent in for repair but the reason was unknown.It was only sent in for preventive maintenance, hence there was no patient involvement, ho harm or delay involved.No adverse events were reported as a result of this malfunction.Investigation found that the hose had a leak.
 
Manufacturer Narrative
Complaint has been recorded by zimmer biomet under (b)(4).Review of the most recent repair record determined the hose had a leak, control bar was not in the correct position, and the calibration was out and the hose, head, control bar, thickness control lever, thickness control shaft, and hose were replaced and resolved the reported issue.A definitive root cause cannot be determined.No corrective actions, preventive actions, or field actions resulted after investigation of this event.The event is confirmed.
 
Event Description
It was reported that the unit was sent in for repair but the reason was unknown.It was only sent in for preventive maintenance, hence there was no patient involvement, ho harm or delay involved.No adverse events were reported as a result of this malfunction.Investigation found that the hose had a leak.
 
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Brand Name
DERMATOME AN HANDPIECE
Type of Device
DERMATOME
Manufacturer (Section D)
ZIMMER SURGICAL, INC.
200 west ohio avenue
dover OH 44622
Manufacturer (Section G)
ZIMMER SURGICAL, INC.
200 west ohio avenue
dover OH 44622
Manufacturer Contact
christina arnt
56 e. bell drive
warsaw, IN 46582
5745273773
MDR Report Key13598761
MDR Text Key286118967
Report Number0001526350-2022-00177
Device Sequence Number1
Product Code GFD
UDI-Device Identifier00889024464834
UDI-Public(01)00889024464834(11)180524(10)64034696
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 02/24/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/25/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberN/A
Device Catalogue Number88710100
Device Lot Number64034696
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/23/2021
Was the Report Sent to FDA? No
Date Manufacturer Received02/08/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/10/2020
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Removal/Correction NumberN/A
Patient Sequence Number1
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