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

Catalog Number W810T

Device Problem Delivered as Unsterile Product (1421)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/20/2024

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).Additional information: h6 component code: g07002 - device not returned additional information has been requested however not received.If further details are received at a later date a supplemental medwatch will be sent.Are there any photos of the product available? was the sterility of the device compromised? - please describe the sterile packaging: - were there any issues with the seal of the sterile packaging? - are there any tears/holes in the sterile packaging? ------------ other information requested is unknown.No product is available for return.Note: events reported on mw# 2210968-2024-04894.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.

Event Description

It was reported a patient underwent an unknown procedure on (b)(6) 2024 and bone wax was used.Product melted.The nurse opened the intact original packaging of bone wax and found that two packages of bone wax were stuck together and had a dissolution phenomenon.They were contaminated and cannot be used.Other bone waxes in the same box are normal and intact.The operating room temperature and humidity meet the storage conditions for bone wax.Additional information has been requested.

• Brand Name: BONE WAX
• Type of Device: STERILE NONABSORBABLE BONE WAX
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-BRAZIL; rodovia presidente dutra; km 154; sao paulo 12240 ; BR 12240
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 19184991
• MDR Text Key: 341583854
• Report Number: 2210968-2024-04895
• Device Sequence Number: 1
• Product Code: MTJ
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: PRE-AMEND
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/25/2024

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 Catalogue Number: W810T
• Device Lot Number: AU4379
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/03/2024
• Initial Date FDA Received: 04/25/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/19/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1