MAUDE Adverse Event Report: ZIMMER SURGICAL, INC. BACTISURE WOUND LAVAGE; LAVAGE, JET

Model Number N/A

Device Problem Use of Device Problem (1670)

Patient Problems Burning Sensation (2146); No Code Available (3191)

Event Date 06/30/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation because it has been used by the facility.However, the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.The product was used by the facility.

Event Description

It was reported that a male patient experienced "burning" 5 days after surgery.The product was used through a scope for 40 seconds and then flushed out with 3 liters of saline.An additional knee scope was conducted 5 days after the initial surgery when the knee was washed out with saline and not the product.No additional patient consequences were reported.

• Brand Name: BACTISURE WOUND LAVAGE
• 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: 6723041
• MDR Text Key: 80377913
• Report Number: 0001526350-2017-00425
• Device Sequence Number: 1
• Product Code: FQH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/18/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00888700100
• Device Lot Number: Q1701185
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/06/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/27/2012
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 34 YR
• Patient Weight: 84