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

Catalog Number W31C

Device Problem Loss of or Failure to Bond (1068)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).The device history records were reviewed and the manufacturing criteria was met prior to the release of this lot.The single complaint was reported with multiple events.There are no additional details regarding the additional patient events.Attempts are being made to obtain the following information and the following was obtained: it was reported that this event occurred in multiple procedures, please provide the following information: what is the total number of procedures? as per event description, approx 6-8 case a week where bone wax is used and customer is complaining about the product.Have any of these events been previously reported to ethicon? if so, provide the respective reference number(s).As per event description it has been logged under another complaint file.What are the procedure name(s) and date(s)? dates not provided, these are used in cardiac procedures.Was there any adverse patient consequence(s) or subsequent medical/surgical intervention? none as of yet.They have refused to continue using w31c, in order to prevent an adverse reaction from occurring.Are these bone wax opened at the beginning of the procedure and left there until they need to use it? or are they opened when it¿s required during the procedure? opened as customer need them.However there are times that we opened as we know we will use for bigger children.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.

Event Description

It was reported a patient underwent an unknown cardiac surgery on an unknown date and bone wax was used.The wax is crumbling.No adverse patient consequences reported.

• Brand Name: BONE WAX 2.5GRAMS
• Type of Device: WAX, BONE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• Manufacturer (Section G): ETHICON INC. BRAZIL; rodovia presidente dutra; km 154; sao paolo 12240 -908; BR 12240-908
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 8395486
• MDR Text Key: 137991275
• Report Number: 2210968-2019-79311
• Device Sequence Number: 1
• Product Code: MTJ
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: PRE-AMEND
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/11/2019

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 Expiration Date: 03/31/2023
• Device Catalogue Number: W31C
• Device Lot Number: AK5709
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/11/2019
• Initial Date FDA Received: 03/06/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/20/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1