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

Model Number N/A

Device Problems Overheating of Device (1437); Battery Problem (2885)

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

Event Date 12/20/2023

Event Type  malfunction  

Manufacturer Narrative

An investigation into the reported event has been initiated under (b)(4).Once the investigation has been completed, a follow up report will be submitted with the investigation results and any actions taken by the manufacturer.E1 telephone number: (b)(6).G2 country: thailand.

Event Description

It was reported that during an instrument check prior to surgery the battery has a shock and generated heat.There was no patient involvement.Due diligence is in process and there is no additional information available.There was no adverse event associated with this malfunction.

Manufacturer Narrative

This complaint is recorded by zimmer biomet under (b)(4).Once the investigation has been completed, a follow up report will be submitted with the investigation results and any actions taken by the manufacturer.

Event Description

It was reported that during an instrument check prior to surgery the battery has a shock and generated heat.There was no damage to the battery or battery pack.There was no harm due to the battery overheating.Due diligence is complete and there is no additional information available.There was no adverse event associated with the malfunction.

Manufacturer Narrative

This complaint is recorded by zimmer biomet under (b)(4).Functional testing found the device would not power on with the original battery pack but did power on and function normally in both modes when connected to a lab battery pack.Visual inspection of the interior of the pack found the batteries had leaked electrolyte inside of the pack.The batteries were installed in the correct orientation inside the pack.There did not appear to be damage to the wiring of the pack.Review of the device history record identified no deviations or anomalies during manufacturing.The root cause of the reported issue is attributed to manufacturing issue.The event is confirmed.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

There is no additional information available regarding the event.

• 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: jennifer rapsavage ; 56 e. bell drive; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 18495861
• MDR Text Key: 332688724
• Report Number: 0001526350-2024-00065
• Device Sequence Number: 1
• Product Code: FQH
• UDI-Device Identifier: 00889024375185
• UDI-Public: (01)00889024375185(17)260801(10)71754429
• Combination Product (y/n): N
• Reporter Country Code: TH
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 05/03/2024

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 Model Number: N/A
• Device Catalogue Number: 00515048200
• Device Lot Number: 71754429
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/20/2023
• Initial Date FDA Received: 01/11/2024
• Supplement Dates Manufacturer Received: 01/22/2024; 05/03/2024
• Supplement Dates FDA Received: 02/16/2024; 05/03/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/03/2023
• 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
• Patient Sex: Prefer Not To Disclose