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U.S. Department of Health and Human Services

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

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ZIMMER SURGICAL, INC. PULSAVC PLUS FAN SPRAY KIT INT; LAVAGE, JET Back to Search Results
Model Number N/A
Device Problems Battery Problem (2885); Expulsion (2933); Explosion (4006)
Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/18/2020
Event Type  malfunction  
Manufacturer Narrative
This event has been recorded by zimmer biomet under (b)(4).(b)(6).Once the investigation is complete, a follow up/final report will be submitted.
 
Event Description
It was reported that during the surgery, it was found that the batteries were exploded inside of the sterile tray before opened this complaint product.There was no harm or injury to the patient.There was a delay of 0-15 minutes to prepare an alternate product to complete the procedure.No adverse events were reported as a result of this malfunction.
 
Event Description
No additional event information available.
 
Manufacturer Narrative
This event has been recorded by zimmer biomet under (b)(4).This medwatch is being filed to relay additional information.Visual examination of the returned product and provided pictures identified that the battery pack was busted open and debris and internal parts of the battery pack were found throughout the package.Review of the device history record identified no deviations or anomalies during manufacturing related to the reported event.Device is used for treatment.Complaints are monitored through monthly complaint review in order to identify potential adverse trends.A definitive root cause cannot be determined.The event is confirmed.
 
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Brand Name
PULSAVC PLUS FAN SPRAY KIT INT
Type of Device
LAVAGE, JET
Manufacturer (Section D)
ZIMMER SURGICAL, INC.
200 west ohio avenue
dover OH 44622
MDR Report Key11146747
MDR Text Key226011459
Report Number0001526350-2021-00031
Device Sequence Number1
Product Code FQH
UDI-Device Identifier00889024375161
UDI-Public(01)00889024375161(17)230630(10)64750039
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 03/09/2021
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 Date06/30/2023
Device Model NumberN/A
Device Catalogue Number00515047501
Device Lot Number64750039
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/25/2021
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 12/21/2020
Initial Date FDA Received01/11/2021
Supplement Dates Manufacturer Received03/03/2021
Supplement Dates FDA Received03/09/2021
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A
Patient Sequence Number1
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