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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER SURGICAL, INC. PULSAVAC + HIP KIT 10/BOX; LAVAGE, JET

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ZIMMER SURGICAL, INC. PULSAVAC + HIP KIT 10/BOX; LAVAGE, JET Back to Search Results
Catalog Number 00515048200
Device Problem Expulsion (2933)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/29/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4).The device history record (dhr) for 00515048200, lot number z000011419, review noted no related non-conformance's, requests for deviation (rfd), change notices (cn), or any other issues with manufacturing.The dhr review found no issues with the device and all verifications, inspections, and tests were successfully completed.On (b)(6) 2019, it was reported from ichilov that the nurse has observed strange and greyish particles.This was not used for the surgery and an alternate device was opened instead.On (b)(6) 2019, a returned product investigation was performed on the (b)(4).The physical evaluation revealed that the device had a ruptured battery.The results of the returned product investigation have confirmed the reported event.While the returned product investigation confirmed that the (b)(4) batteries had ruptured, it cannot be determined from the information provided what actually caused the reported event.Therefore, based on the information provided, a specific root cause of the reported event cannot be determined.The investigation was based on the information that was provided initially and any information that was obtained throughout the follow-up process.
 
Event Description
During an opening of a sterile item during a surgery, the nurse has observed strange and greyish particles.This was not used for the surgery and an alternate device was opened instead.No adverse events were reported as a result of this malfunction.
 
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Brand Name
PULSAVAC + HIP KIT 10/BOX
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 Key8605757
MDR Text Key146387626
Report Number0001526350-2019-00365
Device Sequence Number1
Product Code FQH
Combination Product (y/n)N
Reporter Country CodeIS
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,foreign
Reporter Occupation Other
Type of Report Initial
Report Date 05/13/2019
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 Date03/31/2021
Device Catalogue Number00515048200
Device Lot NumberZ000011419
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/06/2019
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 04/30/2019
Initial Date FDA Received05/13/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/20/2018
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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