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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
Catalog Number 00515047500
Device Problem Delivered as Unsterile Product (1421)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/19/2023
Event Type  malfunction  
Manufacturer Narrative
This event has been recorded by zimmer biomet under (b)(4).G2 foreign: (b)(6).Evaluation and investigation is in process.Once the investigation is complete, a supplemental report will be filed.
 
Event Description
It was reported that at unknown timing on (b)(6), 2023 a hair-like foreign substance was found inside the sterilization tray but not on the device itself.There was no harm, injury or delay reported.Due diligence is complete; no additional information.No adverse events were reported as a result of this malfunction.
 
Event Description
No additional information is available regarding the incident.
 
Manufacturer Narrative
This event is recorded by zimmer biomet under (b)(4).The product was returned opened, but unused, in the original tyvek tray.Visual inspection confirmed there was a long, hair-like debris on the product tubing.It cannot be confirmed if the device was non-conforming as the packaging was returned open.Review of the device history record identified no deviations or anomalies during manufacturing.A definitive root cause cannot be determined.The event cannot be confirmed.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
 
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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
Manufacturer (Section G)
ZIMMER SURGICAL, INC.
200 west ohio avenue
dover OH 44622
Manufacturer Contact
jennifer rapsavage
56 e. bell drive
warsaw, IN 46582
5745260384
MDR Report Key17806681
MDR Text Key324114378
Report Number0001526350-2023-01193
Device Sequence Number1
Product Code FQH
UDI-Device Identifier00889024375154
UDI-Public(01)00889024375154(17)240524(10)65123209
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 12/15/2023
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 Date05/24/2024
Device Catalogue Number00515047500
Device Lot Number65123209
Was Device Available for Evaluation? Device Returned to Manufacturer
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 08/29/2023
Initial Date FDA Received09/25/2023
Supplement Dates Manufacturer Received12/14/2023
Supplement Dates FDA Received12/15/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/01/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberN/A
Patient Sequence Number1
Patient SexPrefer Not To Disclose
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