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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 Expulsion (2933)
Patient Problem No Patient Involvement (2645)
Event Date 05/13/2019
Event Type  malfunction  
Manufacturer Narrative
This event has been recorded by zimmer biomet under (b)(4).Once the investigation is complete, a supplemental/final medwatch will be filed.Hospital discarded.
 
Event Description
It was reported that the pulsavac plus of wound debridement exploded upon opening from the package.No harm.No delay.No adverse events were reported as a result of this malfunction.
 
Event Description
No additional information available.
 
Manufacturer Narrative
This event has been recorded by zimmer biomet under (b)(4).Unique identifier (udi) number: (b)(4).Dhr review: the device history record (dhr) for 00515047500 lot number 64215408, 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.Technical review and physical evaluation: on (b)(6) 2019, it was reported from east (b)(6) center that the pulsavac plus of wound debridement exploded upon opening from the package.A returned product investigation could not be performed for the reported event due to the product not being returned for evaluation.Photos of the device were provided by the account, however.The photos indicate that the a device had a ruptured battery.These photos confirm the reported event.Probable cause/root cause: although the reported event was confirmed with photos supplied by the account, it cannot be specifically determined from the information provided what caused the batteries to rupture.Therefore, the root cause could not 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.The occurrence rate falls within the acceptable range, and there was no harm or serious injury.This complaint will be tracked and trended.
 
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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 Key8658723
MDR Text Key147068074
Report Number0001526350-2019-00408
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,user f
Type of Report Initial,Followup
Report Date 08/20/2019
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 Date11/30/2021
Device Model NumberN/A
Device Catalogue Number00515047500
Device Lot Number64215408
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 05/13/2019
Initial Date FDA Received05/31/2019
Supplement Dates Manufacturer Received08/20/2019
Supplement Dates FDA Received08/20/2019
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A
Patient Sequence Number1
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