• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ZIMMER SURGICAL, INC. FAN SPRAY KIT; LAVAGE, JET Back to Search Results
Catalog Number 00515047501
Device Problem Expulsion (2933)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/10/2019
Event Type  malfunction  
Manufacturer Narrative
This event has been recorded by zimmer biomet under (b)(4).Once the investigation is completed, a follow-up/final report will be submitted.
 
Event Description
It was reported that during the surgery, this product didn't work on low mode unless the surgeon keeps gripping the switch and it also stopped working on high mode in a short time.In photos included with the event, one of the batteries expelled acid.No adverse events were reported as a result of this malfunction.
 
Event Description
There was no harm reported, and a delay of 0-15 minutes reported to obtain an alternate device to complete the surgery.No additional event information available.
 
Manufacturer Narrative
D4: udi# (b)(4).Reported issue: it was reported that during the surgery, this product didn't work as usual.This product didn't work on low mode unless the surgeon keep gripping the switch.And this product stopped working on high mode in a short time.The device history record (dhr) for 00515047501 lot number 64245213, 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 (b)(6) hospital that during the surgery, this product didn't work as usual.This product didn't work on low mode unless the surgeon keep gripping the switch.And this product stopped working on high mode in a short time.On 12 august 2019, a returned product investigation was performed on the 00515047501.The physical evaluation revealed that the device was not working as intended, and further review noted corrosion in the battery pack.When the corroded battery was replaced, the device functioned as intended.The results of the returned product investigation have confirmed the reported event.While the returned product investigation confirmed that the 00515047501 was not functioning as intended due to a corroded battery, it cannot be determined from the information provided what actually caused the reported event.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.Review of the information provided during the investigation determined there is no further actions needed at this time.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key8797959
MDR Text Key151301121
Report Number0001526350-2019-00557
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 08/14/2019
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 Date12/31/2021
Device Catalogue Number00515047501
Device Lot Number64245213
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/12/2019
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 07/12/2019
Initial Date FDA Received07/17/2019
Supplement Dates Manufacturer Received08/14/2019
Supplement Dates FDA Received08/14/2019
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A
Patient Sequence Number1
-
-