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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 Problems Charred (1086); Smoking (1585); Expulsion (2933)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/16/2017
Event Type  malfunction  
Manufacturer Narrative
The complaint is being reported by zimmer biomet as (b)(4).The product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
 
Event Description
It was reported the item was opened in prep for a theatre case.Upon opening a cloud of black powder was released from the packaging.The batteries appear to have exploded and the roof of the packaging has also been charred.No patient involvement.No adverse events have been reported as a result of the malfunction.
 
Manufacturer Narrative
This event has been recorded by zimmer biomet under (b)(4).Review of the device history record for 00515047500, lot number z000005514, identified no relevant deviations or anomalies.Product examination could not be performed as no product was returned for this complaint.This complaint canot be confirmed.The reported event claimed that the sealed unit had ruptured before it had been opened.While rare, this kind of event occurs when the batteries overheat from a short circuit.To address this issue, change notice cn 22170 has been implemented to adjust the length of the wires inside the battery pack.This means that there will no longer be a need to tightly fold wires inside the battery pack in order for them to reach their respective circuit contacts.This reduces the risk of a short circuit.The root cause of the reported event could not be specifically determined with the provided information.The investigation was based on the information that was provided initially and any information that was obtained throughout the follow-up process.
 
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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
christina arnt
56 e. bell drive
warsaw, IN 46582
5745273773
MDR Report Key6611789
MDR Text Key76670666
Report Number0001526350-2017-00303
Device Sequence Number1
Product Code FQH
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
PEXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 08/31/2017
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 Date10/31/2019
Device Model NumberN/A
Device Catalogue Number00515047500
Device Lot NumberZ000005514
Other Device ID Number(01) 00889024375154
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 05/16/2017
Initial Date FDA Received06/05/2017
Supplement Dates Manufacturer Received08/30/2017
Supplement Dates FDA Received08/31/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/27/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Removal/Correction NumberN/A
Patient Sequence Number1
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