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

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.

• 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 Key: 8605757
• MDR Text Key: 146387626
• Report Number: 0001526350-2019-00365
• Device Sequence Number: 1
• Product Code: FQH
• Combination Product (y/n): N
• Reporter Country Code: IS
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• 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 Date: 03/31/2021
• Device Catalogue Number: 00515048200
• Device Lot Number: Z000011419
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/30/2019
• Initial Date FDA Received: 05/13/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/20/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1