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

Model Number N/A

Device Problems Expulsion (2933); Power Problem (3010)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/24/2020

Event Type  malfunction  

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).Functional testing of the returned product determined the device would power on and function in low mode, but not high mode when connected to the returned battery pack.Visual examination of the returned product identified the device was used; fluid in the tubing and blood on the handgun.One of the batteries had leaked and crystallized in the terminal.Once the terminal was cleared of the debris and the faulty battery was replaced, the device powered on and functioned properly in both modes.Device is used for treatment.A definitive root cause cannot be determined.The event is confirmed.

Event Description

It was reported that the work time of pulsavac was short and water pressure was low when the surgeon turned on the switch.Investigation found the battery had leaked.No adverse event was reported as a result of this malfunction.

• Brand Name: HIP 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 Key: 11825288
• MDR Text Key: 250871187
• Report Number: 0001526350-2021-00567
• Device Sequence Number: 1
• Product Code: FQH
• UDI-Device Identifier: 00889024375192
• UDI-Public: (01)00889024375192(17)221231(10)6463982
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 05/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2022
• Device Model Number: N/A
• Device Catalogue Number: 00515048201
• Device Lot Number: 6463982
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/12/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/17/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1