MAUDE Adverse Event Report: ETHICON INC. BONE WAX; STERILE NONABSORBABLE BONE WAX

Catalog Number W810T

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

Patient Problem No Code Available (3191)

Event Date 08/05/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).(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.Attempts are being made to obtain 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 were cultures performed of the wound secretion? if yes, results? other relevant patient history/concomitant medications if applicable, will product be returned, return date, tracking information what is physician¿s opinion as to the etiology of or contributing factors to this event? what is the patient¿s 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 the surgery of removal of internal fixation on (b)(6) 2020 and bone wax was used for occlusion of internal fixation screw holes in thoracic vertebrae.The patient suffered from wound secretion on (b)(6) 2020.The healthcare professional suspected that it may caused by the bone wax.The patient underwent local dressing changes and drainage.Antibiotics were given to the patient, and red light physiotherapy was also given for treatment.The patient was discharged from the hospital on (b)(6) 2020.Additional information has been requested.

Manufacturer Narrative

(b)(4).Date sent to the fda: 12/8/2020.Additional information: d4, h4, h6.Additional h6 component code: g07002 - device not returned.A manufacturing record evaluation was performed for the finished device lot number am5766, and no non conformances / manufacturing irregularities were identified.Additional information was requested and the following was obtained: if applicable, will product be returned, return date, tracking information---the sample isn't available for return.What is the patient¿s current status?---the patient recovered well and got discharged from the hospital on (b)(6) 2020.The following information was requested but unavailable: the patient demographic info: weight, bmi at the time of index procedure were cultures performed of the wound secretion? if yes, results? other relevant patient history/concomitant medications.What is physician¿s opinion as to the etiology of or contributing factors to this event? 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, or its employees that the report constitutes an admission that the product, ethicon, 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: STERILE NONABSORBABLE BONE WAX
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 10788938
• MDR Text Key: 214798616
• Report Number: 2210968-2020-08695
• 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: 10/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: W810T
• Device Lot Number: AM5766
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 50 YR