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

Catalog Number W810T

Device Problems Device Markings/Labelling Problem (2911); Material Integrity Problem (2978)

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

Event Date 12/15/2021

Event Type  malfunction  

Event Description

Before use on the patient on (b)(6) 2021, it was reported that the devices wax oil leaked and the printing on the packaging was illegible.This issue was found during checking and was not involved in any surgery.No adverse patient consequences were reported.Additional information was requested.

Manufacturer Narrative

(b)(4).The following information was requested, and the following was obtained: it was reported that it was reported that "the devices wax oil leakage and customer complaint that the printing on the packaging was illegible as attached photo shows." quantity of products involved was entered as 49.Could you please confirm if 49 devices were observed with oil leakage and illegible printing on the packaging?yes.If other, please clarify how many devices were observed with wax oil leakage and how many with illegible packaging.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.There are 24 packages in the box.Were 2 boxes of (b)(4) plus 1 extra involved in this complaint? what was the storage conditions of the product? was the outer shipment box damaged during shipping? was the packaging damaged on the inner boxes? was the cellophane wrapping sealed on the inner boxes? was there any evidence that the packaging integrity was compromised (open seal or hole in package)? what in the customers opinion was the source of the oil leakage? events reported via: 2210968-2022-00397 and 2210968-2022-00398.

Manufacturer Narrative

Product complaint # (b)(4).Date sent to the fda: 02/14/2022.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 was requested and the following was obtained: there are 24 packages in the box.Were 2 boxes of product code w810t plus 1 extra involved in this complaint? according to feedback of the sales, 2 boxes of product code w810t plus 1 extra involved in this complaint.What was the storage conditions of the product? they were stored in a standard storage warehouse at normal temperature (below 25).Was the outer shipment box damaged during shipping? no.Was the packaging damaged on the inner boxes? no.Was the cellophane wrapping sealed on the inner boxes? yes.Was there any evidence that the packaging integrity was compromised (open seal or hole in package)? no, no open seal or hole in package.What in the customers opinion was the source of the oil leakage? unk.Photo analysis: visual analysis of the three images submitted for evaluation determined that open boxes and several closed samples of product code w810t could be seen.Visual inspection concluded that the bone wax stick apparently melted in an open folder.As part of our quality process, the manufacturing records for this batch serial number were reviewed and manufacturing standards were met prior to the release of this batch.No conclusion could be reached on the cause of the reported complaint as the sample was not returned for analysis.It should be noted that as part of our quality process, the device is visually inspected and functionally tested during manufacturing to ensure it meets the required specifications prior to shipment.Additional monitoring of complaint information for potential safety signals will be conducted through complaint trends as part of post-market surveillance.A manufacturing record evaluation was performed for the finished device lot number, and no non conformances / manufacturing irregularities were identified.

• 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: 13256303
• MDR Text Key: 283960327
• Report Number: 2210968-2022-00399
• 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: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2022
• 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: AP3960
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/17/2022
• 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