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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER SURGICAL, INC. FAN SPRAY KIT; LAVAGE, JET

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ZIMMER SURGICAL, INC. FAN SPRAY KIT; LAVAGE, JET Back to Search Results
Model Number N/A
Device Problems Fluid/Blood Leak (1250); Battery Problem (2885)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/22/2021
Event Type  malfunction  
Manufacturer Narrative
This event has been recorded by zimmer biomet under cmp-(b)(4).Once the investigation is completed, a follow-up/final report will be submitted.
 
Event Description
It was reported that the fan spray kit didn't work when the surgeon turned on the switch.Surgeon found battery leakage when he opened battery pack.The surgeon used another product.There was no harm, no delay, and no medical intervention.No adverse events have been reported as a result of the malfunction.
 
Manufacturer Narrative
This event has been recorded by zimmer biomet under (b)(4).Visual examination of the returned product/provided pictures identified the device was returned opened, unused in the original tyvek tray.Visual inspection of the interior of the battery pack found one of the batteries had leaked inside the pack.No other damage was found.Functional testing found the device powered on and functioned normally when connected to the lab battery pack.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
FAN SPRAY KIT
Type of Device
LAVAGE, JET
Manufacturer (Section D)
ZIMMER SURGICAL, INC.
200 west ohio avenue
dover OH 44622
MDR Report Key11613107
MDR Text Key243742159
Report Number0001526350-2021-00378
Device Sequence Number1
Product Code FQH
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 06/28/2021
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 Expiration Date10/22/2023
Device Model NumberN/A
Device Catalogue Number00515047501
Device Lot Number64911827
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/16/2021
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 03/26/2021
Initial Date FDA Received04/05/2021
Supplement Dates Manufacturer Received06/28/2021
Supplement Dates FDA Received06/28/2021
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A
Patient Sequence Number1
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