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

Model Number W31G

Device Problem Device Contaminated During Manufacture or Shipping (2969)

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

Event Date 03/16/2021

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).Attempts have been made to retrieve the device.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.Additional information was requested and the following was obtained: please provide the procedure name and date it was a neuro pack, and it was reported on (b)(6).

Event Description

It was reported that a patient underwent a neurological procedure on (b)(6) 2021.Before use on the patient, it was reported by the distributor that a hair was found within the bone wax packaging.No adverse patient consequences were reported.Additional information was requested.

Manufacturer Narrative

Date sent to the fda: 06/01/2021.Additional h6 component codes: g07002 ¿ device not returned.A manufacturing record evaluation was performed for the finished device lot number an4947 /w31g, and no non-conformances related to the reported complaint condition 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 12 X 2.5GRAMS
• Type of Device: WAX, BONE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• MDR Report Key: 11765714
• MDR Text Key: 250003806
• Report Number: 2210968-2021-04172
• Device Sequence Number: 1
• Product Code: MTJ
• UDI-Device Identifier: 10705031056992
• UDI-Public: 10705031056992
• 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: distributor
• Type of Report: Initial,Followup
• Report Date: 04/07/2021

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 Model Number: W31G
• Device Catalogue Number: W31G
• Device Lot Number: AN4947
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/07/2021
• Initial Date FDA Received: 05/03/2021
• Supplement Dates Manufacturer Received: 06/01/2021
• Supplement Dates FDA Received: 06/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1