MAUDE Adverse Event Report: ETHICON INC. BONE WAX; WAX, BONE

Catalog Number W31

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Unspecified Infection (1930)

Event Date 09/23/2020

Event Type  Injury  

Manufacturer Narrative

Product complaint (b)(4).To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent the following information was requested, but unavailable: the patient demographic info: age, gender, weight, bmi at the time of index procedure date and indication for index surgical procedure? where in the patient¿s body was the bonewax placed? was the excess bonewax removed from the operative site? were there any pre-existing signs/symptoms of active infection prior to this surgical procedure? did the patient receive any prophylactic antibiotics pre-, intra- or post-operation? what were current symptoms following the index surgical procedure? onset date? tissue/structure and appearance of infection? were cultures performed? results? what medical intervention was done to treat infection? results? was any surgical intervention required? if yes, please provide a date and details.Did the operating surgeon observe any bonewax deficiency or anomaly before, during, after the bonewax placement or during any re-operation? other relevant patient comorbidities/concomitant medications what is physician¿s opinion as to the etiology of or contributing factors to this event? what is the patient current status? if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

It was reported that the patient underwent an open heart surgery on unknown date and the bone wax was used on the sternum.After the surgery, the patient experienced infection.No further information is available.

Manufacturer Narrative

Date sent to the fda: 11/04/2020.A manufacturing record evaluation was performed for the finished device lot number an4829, and no non conformances / manufacturing irregularities were identified.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon inc, or its employees that the report constitutes an admission that the product, ethicon inc, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: BONE WAX
• Type of Device: WAX, BONE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 10659822
• MDR Text Key: 211104357
• Report Number: 2210968-2020-07852
• Device Sequence Number: 1
• Product Code: MTJ
• Combination Product (y/n): N
• PMA/PMN Number: PRE-AMEND
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 09/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: W31
• Device Lot Number: AN4829
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/24/2020
• Initial Date FDA Received: 10/09/2020
• Supplement Dates Manufacturer Received: 11/04/2020
• Supplement Dates FDA Received: 11/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1