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

Model Number N/A

Device Problems Inability to Irrigate (1337); Noise, Audible (3273)

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

Event Date 03/02/2022

Event Type  malfunction  

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).Telephone number: (b)(6).Investigation is complete.This is an initial final report submission.Functional testing of the returned product identified the suction was not working and the motor made a high pitched noise.Visual examination of the interior of the hand piece found the motor mounts were melted and warped, dropping the motor out of position and preventing the pinion gear from making contact with the face gear.There were brown burn marks found on the corners of the motor mounts.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

It was reported that during surgery the product pump was not working and would not spray and an unusual noise occurred when switched on.No harm or delay reported.At product evaluation brown burn marks found on the corners of the motor mounts.No adverse events were reported as a result of this malfunction.No additional event information available.

• Brand Name: FAN SPRAY 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: 14522847
• MDR Text Key: 292833084
• Report Number: 0001526350-2022-00519
• Device Sequence Number: 1
• Product Code: FQH
• UDI-Device Identifier: 00889024375154
• UDI-Public: (01)00889024375154(17)240324(10)65058749
• Combination Product (y/n): N
• Reporter Country Code: MY
• 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: Physician
• Type of Report: Initial
• Report Date: 05/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/27/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/24/2024
• Device Model Number: N/A
• Device Catalogue Number: 00515047500
• Device Lot Number: 65058749
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/17/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/25/2021
• 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