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

Catalog Number 00515047501

Device Problem Expulsion (2933)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/04/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Customer has indicated that the product is in process of being returned to zimmer biomet.Once the product is returned and the investigation is complete, a follow up/final report will be submitted.(b)(4).

Event Description

It was reported that during the surgery, the surgeon found that some liquid leaked from the battery when he opened it.Therefore, the surgeon used an alternate product to complete the surgery.There was no harm or delay involved.No adverse events were reported as a result of this malfunction.

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, d4, d10, g4, g7, h2, h3, h4, h6, h10.D4: udi #: (b)(4).The device history record (dhr) for 00515047501 lot number 64054531, review noted no related non-conformances, requests for deviation (rfd), change notices (cn), or any other issues with manufacturing.The dhr review found no issues with the device and all verifications, inspections, and tests were successfully completed.On (b)(6) 2019, it was reported from (b)(6) hospital that it was reported that during the surgery, the surgeon found that some liquid leaked from the battery when he opened it.On 29 march 2019, a returned product investigation was performed on the 00515047501.The physical evaluation revealed that the device batteries had corroded and leaked into the sterile tray.The results of the returned product investigation have confirmed the reported event.While the returned product investigation confirmed that the 00515047501 batteries had corroded within the sterile packaging, it cannot be determined from the information provided what actually caused the batteries to corrode.Therefore, based on the information provided, a specific root cause of the reported event cannot be determined.The investigation was based on the information that was provided initially and any information that was obtained throughout the follow-up process.

Event Description

No additional event information available.

• Brand Name: FAN SPRAY KIT
• Type of Device: DISPOSABLE BATTERY-POWERED SURGICAL/ORTHOPAEDIC LAVAGE SYSTEM
• Manufacturer (Section D): ZIMMER SURGICAL, INC.; 200 west ohio avenue; dover OH 44622
• MDR Report Key: 8416000
• MDR Text Key: 138755482
• Report Number: 0001526350-2019-00157
• 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: 04/03/2019

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: 05/31/2021
• Device Catalogue Number: 00515047501
• Device Lot Number: 64054531
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/06/2019
• Initial Date FDA Received: 03/13/2019
• Supplement Dates Manufacturer Received: 04/03/2019
• Supplement Dates FDA Received: 04/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1