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U.S. Department of Health and Human Services

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

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ZIMMER SURGICAL, INC. PULSAVAC PLUS FAN SPRAY KIT; LAVAGE, JET Back to Search Results
Model Number N/A
Device Problems Burst Container or Vessel (1074); Expulsion (2933)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/20/2017
Event Type  malfunction  
Manufacturer Narrative
The udi number is (b)(4).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 during preparation for surgery, it was found that the product looked like it had exploded inside of the sterile package when the dealer opened the product's outer box.No adverse events have been reported as a result of the malfunction.
 
Manufacturer Narrative
(b)(4).Initial medwatch was submitted erroneously.This is not reportable.
 
Manufacturer Narrative
This complaint is recorded with zimmer biomet under (b)(4).This medwatch is being filed as a initial although g7 states "follow-up" as it was earlier flipped for non-reportability per guidelines and has now been switched to being reportable to the fda.Review of the device history record for 00515047501, lot number z000005750, identified no relevant deviations or anomalies.Product examination found that the battery pack had ruptured from overheating batteries.The sealed packaging had not been opened.This complaint is confirmed.The reported event claimed that the sealed unit had ruptured before it had been opened.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.
 
Event Description
It was reported that during preparation for surgery, it was found that the product looked like it had exploded inside of the sterile package when the dealer opened the product's outer box.No adverse events have been reported as a result of the malfunction.
 
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Brand Name
PULSAVAC PLUS 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 Key6585458
MDR Text Key75778323
Report Number0001526350-2017-00297
Device Sequence Number1
Product Code FQH
Combination Product (y/n)N
Reporter Country CodeJA
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,Followup
Report Date 08/03/2017
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 Number00515047501
Device Lot NumberZ000005750
Other Device ID Number00889024375161
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/14/2017
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 05/12/2017
Initial Date FDA Received05/23/2017
Supplement Dates Manufacturer ReceivedNot provided
08/03/2017
Supplement Dates FDA Received05/24/2017
08/03/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/18/2016
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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