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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 Problem Battery Problem (2885)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/12/2019
Event Type  malfunction  
Manufacturer Narrative
This event has been recorded by zimmer biomet under (b)(4).Once the investigation is complete, a follow up/final report will be submitted.
 
Event Description
It was reported that during the surgery, this product didn't work on high from the start of use.Upon receipt of the device and evaluation it was found that there was battery deposits or leakage.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, d10, g4, g7, h2, h3, h6, h10.Reported issue: it was reported that during the surgery, this product didn't work on high from the start of use.Upon receipt of the device and evaluation it was found that there was battery deposits or leakage.Dhr and repair history review: this investigation is being completed as a limited investigation as no problem was found with the device.Therefore the complaint history and dhr reviews are not required.Technical review and physical evaluation: on (b)(6) 2019, it was reported from (b)(6) hospital that during the surgery, this product didn't work on high from the start of use.On 13 november 2019, a returned product investigation was performed on the 00515047501.The physical evaluation revealed that the device functions as intended and there were no problems with the device.The results of the returned product investigation have not confirmed the reported event.Probable cause/root cause: the reported event was never confirmed during inspection of the device, and no problems were found with the unit.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.Conclusion: review of the information provided during the investigation determined there is no further actions needed at this time.This complaint will be tracked and trended for any adverse trends that may warrant further action.
 
Event Description
No additional event information available.
 
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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 Key9432238
MDR Text Key191537072
Report Number0001526350-2019-01126
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 01/23/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberN/A
Device Catalogue Number00515047501
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/13/2020
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 11/12/2019
Initial Date FDA Received12/06/2019
Supplement Dates Manufacturer Received01/16/2020
Supplement Dates FDA Received01/23/2020
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A
Patient Sequence Number1
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