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

Model Number N/A

Device Problem Expulsion (2933)

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

Event Date 03/27/2020

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 during the surgery, this product didn't work normally from the start of use.Therefore, the surgeon used an alternative same product to complete the surgery.After the product was received, it was inspected from inside.It was confirmed that the foreign substance which looks like the deposit from the electrolyte is adhered on the battery's and the battery pack's electrodes.No adverse event was reported as a result of this malfunction.

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).D4 udi : (b)(4) this medwatch is being filed to relay additional information.Visual examination of the provided pictures identified a white residue on the battery.The device history records for the lot number were reviewed for deviations and/or anomalies with the following related anomalies/deviations identified.Device is used for treatment.A definitive root cause cannot be determined.The event is confirmed.

Event Description

No additional event information available.

Event Description

There is no additional information.

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).This medwatch is being filed to relay additional information.The following sections were updated/corrected: b4, b5, d8, d9, g3, g6, h2, h3, h6, h10.Visual examination of the returned product/provided pictures identified the device was returned opened, in the original box without the tray or lid.Visual inspection determined the device was used, as there was spots of dried fluid inside the tubing and suction.No damage could be found to the device or battery pack.No evidence of electrolyte was found in the battery pack.Functional testing found the device powered on and worked normally when connected to the battery pack provided with the device.A definitive root cause cannot be determined.The event cannot be confirmed.

• 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: 9942687
• MDR Text Key: 188432934
• Report Number: 0001526350-2020-00363
• Device Sequence Number: 1
• Product Code: FQH
• UDI-Device Identifier: 00889024375161
• UDI-Public: (01)00889024375161
• 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: 03/25/2021

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: 10/31/2020
• Device Model Number: N/A
• Device Catalogue Number: 00515047501
• Device Lot Number: 63821851
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/30/2020
• Initial Date FDA Received: 04/09/2020
• Supplement Dates Manufacturer Received: 08/28/2020; 03/22/2021
• Supplement Dates FDA Received: 08/28/2020; 03/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1