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

Catalog Number 00515047501

Device Problems Corroded (1131); Fluid/Blood Leak (1250)

Patient Problem No Patient Involvement (2645)

Event Date 10/01/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Upon receipt of additional information, the product return and the investigation is complete, a follow up/final report will be submitted.

Event Description

It was reported that the device would not work in high mode during surgery.Upon receiving the device for repair/inspection it was discovered that there was buildup/ leakage around the battery.There was no patient harm or involvement as a result of this incident.

Event Description

No additional event information.

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).Reported issue: it was reported that during the surgery, this product didn't work on high mode from the beginning.Photos reveal the battery was leaking the device history record (dhr) for 00515047502 lot number 64245126, 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 during the surgery, this product didn't work on high mode from the beginning.Photos reveal the battery was leaking.On 05 november 2019, a returned product investigation was performed on the 00515047501.The physical evaluation revealed that the device functioned as intended.Therefore the reported event of the unit not working in high mode could not be confirmed.Upon further inspection, it was noted that there was some light corrosion on the battery terminals.The results of the returned product investigation have confirmed the reported event of the battery leaking.The reported event of the device not working in high mode was never confirmed during inspection of the device, and it was noted in the investigation that the device functioned as intended.However, the reported event of the battery leaking was confirmed during inspection, and it was noted that there was corrosion within the battery pack.The root cause of the corrosion could not be determined.The investigation was based on the information that was provided initially and any information that was obtained throughout the follow-up process.Review of the information provided during the investigation determined there is no further actions needed at this time (ie/capa/scar/hhe/d).This complaint will be tracked and trended for any adverse trends that may warrant further action.

• Brand Name: PULS PLUS 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: 9217730
• MDR Text Key: 164103634
• Report Number: 0001526350-2019-00914
• 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: 11/12/2019

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: 12/31/2021
• Device Catalogue Number: 00515047501
• Device Lot Number: 64245126
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/04/2019
• Initial Date FDA Received: 10/22/2019
• Supplement Dates Manufacturer Received: 11/07/2019
• Supplement Dates FDA Received: 11/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1