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

Model Number N/A

Device Problems Shipping Damage or Problem (1570); Battery Problem (2885); Expulsion (2933)

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

Event Date 03/15/2021

Event Type  malfunction  

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).Once the investigation is completed, a follow-up/final report will be submitted.

Event Description

It was reported that before shipping to the hospital, our distributor found a lot of black granular sand in the package.There was no adverse event reported as a result of this malfunction.

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).D4: udi#: (b)(4).-visual inspection of the returned product confirmed there was an expulsion of the battery pack -review of the device history record identified no deviations or anomalies during manufacturing related to the reported event.-device is used for treatment.- complaints are monitored through monthly complaint review in order to identify potential adverse trends.-the root cause of the reported issue is attributed to a manufacturing operator error.Actions were initiated as a result of the investigation of this event.-the event is confirmed.

Event Description

No additional information.

• Brand Name: FAN SPRAY KIT
• Type of Device: LAVAGE, JET
• Manufacturer (Section D): ZIMMER SURGICAL, INC.; 200 west ohio avenue; dover OH 44622
• MDR Report Key: 11615157
• MDR Text Key: 243964164
• Report Number: 0001526350-2021-00381
• 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: 06/08/2021

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: 10/28/2023
• Device Model Number: N/A
• Device Catalogue Number: 00515047500
• Device Lot Number: 64925604
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/15/2021
• Initial Date FDA Received: 04/05/2021
• Supplement Dates Manufacturer Received: 06/08/2021
• Supplement Dates FDA Received: 06/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1