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

Catalog Number 00515048200

Device Problem Expulsion (2933)

Patient Problem No Patient Involvement (2645)

Event Date 02/22/2019

Event Type  malfunction  

Manufacturer Narrative

This event has been recorded under zimmer biomet complaint number (b)(4).The device has been returned for evaluation and investigation is in process.Once the investigation is completed, a supplemental report will be filed accordingly.

Event Description

The customer reported that before using the product the operators noticed that the battery housing has increased in volume with leak of the content in the packaging.Another device has been used.No adverse events have been recorded as a result of this malfunction.

Event Description

No additional information received.

Manufacturer Narrative

This event has been recorded under zimmer biomet complaint number (b)(4).Udi# (b)(4).The following section has been updated: b5,d4,g4,g7,h2,h3, h4, h6, h10 the device history record (dhr) for 00515048200 lot number 29370093, review noted no related non-conformances, 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 (b)(6) that the customer reported that before using the product the operators noticed that the battery housing has increased in volume with leak of the content in the packaging.On 25 march 2019, a returned product investigation was performed on the 00515048200.The physical evaluation revealed that the battery had ruptured inside of the packaging.The results of the returned product investigation have confirmed the reported event.While the returned product investigation confirmed that the 00515048200 batteries had ruptured inside of device packaging, 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.

• 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
• MDR Report Key: 8452393
• MDR Text Key: 139869817
• Report Number: 0001526350-2019-00192
• Device Sequence Number: 1
• Product Code: FQH
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 05/10/2019

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: 09/30/2021
• Device Catalogue Number: 00515048200
• Device Lot Number: 29370093
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/01/2019
• Initial Date FDA Received: 03/26/2019
• Supplement Dates Manufacturer Received: 05/09/2019
• Supplement Dates FDA Received: 05/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1