MAUDE Adverse Event Report: ETHICON INC. BONE WAX 12 X 2.5GRAMS; WAX, BONE

Catalog Number W31C

Device Problem Material Integrity Problem (2978)

Patient Problem Insufficient Information (4580)

Event Date 01/01/2021

Event Type  Injury  

Manufacturer Narrative

Product complaint (b)(4).(b)(4).Device not returned.To date the device has not been returned.If the device or further details are received at the later date a supplemental medwatch will be sent.Attempts are being made to clarify the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.The patient demographic info: weight, bmi at the time of index procedure? date, name and/or indication of index surgical procedure? where in the patients body was the device placed? was the excess bone wax removed from the operative site? product lot number? did the operating surgeon observe any product deficiency or anomaly before or during product placement? please clarify what does bone wax dislodge mean? how was the dislodged bonewax observed/diagnosed? and when? please specify if there were any post-op symptoms that the patient experienced due to dislodged bone wax? date and findings of reoperation? what is the physicians opinion as to the etiology of or contributing factors to this event? what is the current condition of the patient? 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 unknown orthopedic procedure on unknown date last year and the bone wax was placed.It was reported that the bone wax dislodged and the patient required re-operation to remove the bone wax.Additional information was requested.

Manufacturer Narrative

Additional information was requested, and the following was obtained: was the excess bone wax removed from the operative site? yes.The following information was requested, but unavailable: the patient demographic info: weight, bmi at the time of index procedure? date, name and/or indication of index surgical procedure? where in the patient¿s body was the device placed? product lot number? did the operating surgeon observe any product deficiency or anomaly before or during product placement? please clarify what does ¿bone wax dislodge¿ mean? how was the ¿dislodged¿ bonewax observed/diagnosed? and when? please specify if there were any post-op symptoms that the patient experienced due to ¿dislodged¿ bone wax? date and findings of reoperation? what is the physician¿s opinion as to the etiology of or contributing factors to this event? what is the current condition of the patient? 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.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 12 X 2.5GRAMS
• Type of Device: WAX, BONE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08876
• MDR Report Key: 11519606
• MDR Text Key: 241433129
• Report Number: 2210968-2021-02514
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 03/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: W31C
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/25/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 15 YR