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U.S. Department of Health and Human Services

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

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ZIMMER SURGICAL, INC. UNKNOWN ZIMMER FAN SPRAY KIT; LAVAGE, JET Back to Search Results
Device Problem Expulsion (2933)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/08/2017
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 that the device worked "ok during the procedure and nobody was harmed.However, at the end of the case the nurse noticed blackening on the battery pack.No adverse events have been reported as a result of the malfunction.
 
Manufacturer Narrative
This complaint is recorded with zimmer biomet under (b)(4).Review of the device history record could not be performed as no lot number was reported for this complaint.Product examination could not be performed as no product was returned for this complaint.Pictures provided by the customer show that the battery ruptured but the conditions of this rupture are undetermined.This complaint cannot be confirmed.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.
 
Event Description
Investigation results revealed that the battery ruptured.
 
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Brand Name
UNKNOWN ZIMMER 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 Key6656212
MDR Text Key78040752
Report Number0001526350-2017-00388
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 foreign,user facility
Reporter Occupation Physician
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
Other Device ID NumberN/A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 06/14/2017
Initial Date FDA Received06/21/2017
Supplement Dates Manufacturer Received08/29/2017
Supplement Dates FDA Received08/31/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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