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

Model Number N/A

Device Problem Disconnection (1171)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/30/2020

Event Type  malfunction  

Manufacturer Narrative

This event has been recorded by zimmer biomet under cmp-(b)(4).Telephone number: (b)(6).Evaluation and investigation is in process.Once the investigation is complete, a supplemental report will be filed.

Event Description

It was reported that during the surgery, the tip came off from the hand piece.No adverse events were reported as a result of this malfunction.

Manufacturer Narrative

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

Event Description

It was reported that during the surgery, the tip came off from the hand piece.There was no harm or injury to the patient or the operator.There was a 0-15 minute delay to prepare an alternate device.No adverse events were reported as a result of this malfunction.

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).Visual examination of the returned product identified no damage to the device.Functional testing determined the device powered on, worked properly, and the tip and lock stayed in place.Device is used for treatment.A definitive root cause cannot be determined as the device operated within specifications.The event cannot be confirmed.

Event Description

There is 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: 11139278
• MDR Text Key: 225751180
• Report Number: 0001526350-2021-00019
• 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,Followup
• Report Date: 06/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2023
• Device Model Number: N/A
• Device Catalogue Number: 00515047501
• Device Lot Number: 64784655
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1