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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 Connection Problem (2900)
Patient Problem No Patient Involvement (2645)
Event Date 01/16/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(6).Investigation summary: review of the device history record for 00515047500, lot number 63476127, identified no relevant deviations or anomalies.Product examination found that the wire at the base of the hand piece of the unit appeared to have been cut by scissors.This complaint is confirmed.The reported event claimed that the battery wire of the unit was cut and later on the battery pack became hot and close to combustion.It is known that cutting the wire can create a short circuit within the battery pack.The pulsavac ifu states, ¿do not cut the battery pack cable.Cutting through the battery pack cable could lead to shock, excessive heat and/or sparks, and could result in fire and/or personal injury.¿ capa (b)(4) is in process to directly address customers cutting the battery cable.The root cause for this complaint is that the customer cut the wire, creating a short circuit within the battery pack.This short circuit caused the reported event.The investigation was based on the information that was provided initially and any information that was obtained throughout the follow-up process.
 
Event Description
It was reported by the account that the grey cord from the battery was not connected to the hand piece during setup for surgery.Investigation results revealed that cutting the battery wire can cause combustion due to a short circuit.No adverse events were reported as a result of this malfunction.
 
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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 Key6831066
MDR Text Key83997478
Report Number0001526350-2017-00592
Device Sequence Number1
Product Code FQH
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
PEXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Reporter Occupation Medical Equipment Company Technician/Representative
Type of Report Initial
Report Date 08/30/2017
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 Date09/30/2019
Device Model NumberN/A
Device Catalogue Number00515047500
Device Lot Number63476127
Other Device ID Number(01)00889024375154
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/06/2017
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 08/28/2017
Initial Date FDA Received08/30/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/01/2016
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
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