MAUDE Adverse Event Report: ZIMMER SURGICAL, INC. HIP KIT; DISPOSABLE BATTERY-POWERED SURGICAL/ORTHOPAEDIC LAVAGE SYSTEM

Model Number N/A

Device Problem Battery Problem (2885)

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

Event Date 12/06/2021

Event Type  malfunction  

Event Description

It was reported that the foreign substance which seems to be deposit from electrolyte inside of sterile tray.The battery was also found to be corroded.

Manufacturer Narrative

This complaint is recorded by zimmer biomet under (b)(4).A follow up/ final report will be submitted once investigation is complete.

Manufacturer Narrative

Visual inspection confirmed there was a white substance inside the tyvek tray of the device.Inspection of the interior of the battery pack found the batteries had leaked electrolyte inside the pack.Review of the device history record identified no deviations or anomalies during manufacturing related to the reported event.A definitive root cause cannot be determined.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 event information available.

• Brand Name: HIP KIT
• Type of Device: DISPOSABLE BATTERY-POWERED SURGICAL/ORTHOPAEDIC LAVAGE SYSTEM
• Manufacturer (Section D): ZIMMER SURGICAL, INC.; 200 west ohio avenue; dover OH 44622
• Manufacturer (Section G): .; 200 west ohio avenue; dover OH 44622
• Manufacturer Contact: christina arnt ; 56 e. bell drive; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 12962438
• MDR Text Key: 281937532
• Report Number: 0001526350-2021-01330
• Device Sequence Number: 1
• Product Code: FQH
• UDI-Device Identifier: 00880024375192
• UDI-Public: (01)00880024375192(17)240325(10)65064015
• 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: Foreign,Health Professional,User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 04/20/2022

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: 03/28/2024
• Device Model Number: N/A
• Device Catalogue Number: 00515048201
• Device Lot Number: 65064015
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/08/2021
• Initial Date FDA Received: 12/08/2021
• Supplement Dates Manufacturer Received: 04/13/2022
• Supplement Dates FDA Received: 04/21/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/29/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: N/A
• Patient Sequence Number: 1