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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER SURGICAL, INC. FAN SPRAY KIT; DISPOSABLE BATTERY-POWERED SURGICAL/ORTHOPAEDIC LAVAGE SYSTEM

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ZIMMER SURGICAL, INC. FAN SPRAY KIT; DISPOSABLE BATTERY-POWERED SURGICAL/ORTHOPAEDIC LAVAGE SYSTEM Back to Search Results
Catalog Number 00515047501
Device Problem Expulsion (2933)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/04/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4).Customer has indicated that the product is in process of being returned to zimmer biomet.Once the product is returned and the investigation is complete, a follow up/final report will be submitted.(b)(4).
 
Event Description
It was reported that during the surgery, the surgeon found that some liquid leaked from the battery when he opened it.Therefore, the surgeon used an alternate product to complete the surgery.There was no harm or delay involved.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, d4, d10, g4, g7, h2, h3, h4, h6, h10.D4: udi #: (b)(4).The device history record (dhr) for 00515047501 lot number 64054531, review noted no related non-conformances, requests for deviation (rfd), change notices (cn), or any other issues with manufacturing.The dhr review found no issues with the device and all verifications, inspections, and tests were successfully completed.On (b)(6) 2019, it was reported from (b)(6) hospital that it was reported that during the surgery, the surgeon found that some liquid leaked from the battery when he opened it.On 29 march 2019, a returned product investigation was performed on the 00515047501.The physical evaluation revealed that the device batteries had corroded and leaked into the sterile tray.The results of the returned product investigation have confirmed the reported event.While the returned product investigation confirmed that the 00515047501 batteries had corroded within the sterile packaging, it cannot be determined from the information provided what actually caused the batteries to corrode.Therefore, based on the information provided, a specific root cause of the reported event cannot be determined.The investigation was based on the information that was provided initially and any information that was obtained throughout the follow-up process.
 
Event Description
No additional event information available.
 
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Brand Name
FAN SPRAY KIT
Type of Device
DISPOSABLE BATTERY-POWERED SURGICAL/ORTHOPAEDIC LAVAGE SYSTEM
Manufacturer (Section D)
ZIMMER SURGICAL, INC.
200 west ohio avenue
dover OH 44622
MDR Report Key8416000
MDR Text Key138755482
Report Number0001526350-2019-00157
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 company representative,foreig
Type of Report Initial,Followup
Report Date 04/03/2019
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 Date05/31/2021
Device Catalogue Number00515047501
Device Lot Number64054531
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/29/2019
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 03/06/2019
Initial Date FDA Received03/13/2019
Supplement Dates Manufacturer Received04/03/2019
Supplement Dates FDA Received04/03/2019
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A
Patient Sequence Number1
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