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

Catalog Number 00515047501

Device Problems Corroded (1131); Expulsion (2933)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/02/2019

Event Type  malfunction  

Manufacturer Narrative

This event is recorded by zimmer biomet under (b)(4).Udi#: (b)(4).Reported issue: it was reported that during the surgery, this product didn't work on high mode.Dhr review: the device history record (dhr) for 00515047501 lot number 64087316, 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.Technical review and physical evaluation: on (b)(6) 2019, it was reported from (b)(6) hospital that this product didn't work on high mode.On 26 september 2019, a returned product investigation was performed on the 00515047501.The physical evaluation revealed that the device did not operate in high mode.In addition, it was noted that a battery in the battery pack was corroded, preventing the device from powering in high mode.The results of the returned product investigation have confirmed the reported event.Probable cause/root cause: while the returned product investigation confirmed that the 00515047501 was not working in high mode due to a corroded battery, it cannot be determined from the information provided what actually caused the battery 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.Conclusion: review of the information provided during the investigation determined there is no further actions needed at this time.This complaint will be tracked and trended for any adverse trends that may warrant further action.

Event Description

It was reported that during the surgery, the product did not work on high mode.There was no harm/injury to patient.There was a 0-15 minute delay to prepare new a product.During the investigation, it was identified that the battery was corroded.No adverse events were reported as a result of this malfunction.

• 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: christina arnt ; 56 e. bell drive; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 9145145
• MDR Text Key: 162030390
• Report Number: 0001526350-2019-00840
• Device Sequence Number: 1
• Product Code: FQH
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/02/2019

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: 06/30/2021
• Device Catalogue Number: 00515047501
• Device Lot Number: 64087316
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/26/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/30/2019
• Initial Date FDA Received: 10/02/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/20/2018
• 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