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

Catalog Number W810T

Device Problem Device Markings/Labelling Problem (2911)

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

Event Date 11/09/2021

Event Type  malfunction  

Event Description

It was reported that a patient underwent an unknown procedure on (b)(6) 2021 and waxed was used.Before use on patient, it was reported that the device lacked bar code when it was about to be used in an unknown procedure.Another like device was used to complete the surgery.No adverse patient consequences were reported.Additional information was requested.

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.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.Please provide procedure name.Please clarify if there were any adverse patient consequences due to this event? if yes, please explain in detail.Are there any photos for visual analysis? a manufacturing record evaluation was performed for the finished device batch, and no non-conformances were identified.

Manufacturer Narrative

Product complaint #
=
> (b)(4) date sent to the fda: 01/18/2022 h6 component code: g07002 - device not returned 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.Additional information: h6 the following information was requested, but unavailable: * please provide procedure name¿¿ all answers above are unobtainable.Once there is any update, we will update the information.* please clarify if there were any adverse patient consequences due to this event? if yes, please explain in detail * are there any photos for visual analysis?.

• 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 paolo ; BR
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 13056196
• MDR Text Key: 286923536
• Report Number: 2210968-2021-12839
• 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,Followup
• Report Date: 12/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2021
• 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: AP3944
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/23/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/04/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1