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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 Delivered as Unsterile Product (1421)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/27/2023
Event Type  malfunction  
Manufacturer Narrative
An investigation into the reported event has been initiated under (b)(4).Once the investigation has been completed, a follow up report will be submitted with the investigation results and any actions taken by the manufacturer.G2: foreign: japan.
 
Event Description
It was reported that during surgery, a hair was found inside of the sterile tray when the nurse opened the sterile tray.There was no patient harm/injury.There was no medical intervention.There was a 0 -15 minute surgical delay for preparing an alternate device.Due diligence is complete, no further information is available.
 
Event Description
There is no additional information available.
 
Manufacturer Narrative
This event has been recorded by zimmer biomet under (b)(4).The following sections have been corrected/updated: b4, b5, d2, d4, d9, g1, g3, g6, h1, h2, h3, h4, h6, and h10.The device was returned opened but unused.Visual inspection confirmed there was a long dark hair present inside the tyvek tray.Review of the device history record identified no deviations or anomalies during manufacturing related to the reported event.A definitive root cause cannot be determined.The event is 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 Key18061115
MDR Text Key327264054
Report Number0001526350-2023-01436
Device Sequence Number1
Product Code FQH
UDI-Device Identifier00889024375161
UDI-Public(01)00889024375161(17)251107(10)65709059
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,Distributor
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 01/11/2024
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 Model NumberN/A
Device Catalogue Number00515047501
Device Lot Number65709059
Was Device Available for Evaluation? Device Returned to Manufacturer
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 10/13/2023
Initial Date FDA Received11/02/2023
Supplement Dates Manufacturer Received01/11/2024
Supplement Dates FDA Received01/11/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/11/2022
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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