MAUDE Adverse Event Report: ZIMMER SURGICAL, INC. HIP KIT; LAVAGE, JET

Model Number N/A

Device Problem Material Deformation (2976)

Patient Problem No Patient Involvement (2645)

Event Date 10/11/2018

Event Type  malfunction  

Manufacturer Narrative

This complaint is recorded with zimmer biomet under (b)(4).Customer has indicated that 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 unit had grey sand like particles inside the sterile packaging and the battery pack was seen to be split open and appeared to be deformed by heat.Pulsevac was opened in ot in preparation for use in a procedure.No patient involvement.

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).Udi: (b)(4).This medwatch is being filed to relay additional information.The device history record (dhr) for 00515048200 lot number z000011109, 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) 2018, it was reported from (b)(4) that the unit had grey sand like particles inside the sterile packaging and the battery pack was seen to be split open and appeared to be deformed by heat.On 02 november 2018, a returned product investigation was performed on the 00515048200.The physical evaluation revealed that the device batteries had ruptured and the battery case was deformed.The results of the returned product investigation have confirmed the reported event.While the returned product investigation confirmed that the 00515048200 had a ruptured battery, 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

No additional event information.

• Brand Name: HIP KIT
• Type of Device: LAVAGE, JET
• Manufacturer (Section D): ZIMMER SURGICAL, INC.; 200 west ohio avenue; dover OH 44622
• MDR Report Key: 7995321
• MDR Text Key: 125148377
• Report Number: 0001526350-2018-00955
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 01/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2021
• Device Model Number: N/A
• Device Catalogue Number: 00515048200
• Device Lot Number: Z000011109
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1