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

Catalog Number W810

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Bacterial Infection (1735)

Event Date 08/11/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Batch manufacturing records of w810/ b8036 was reviewed for any process deviation but no deviation was observed.Finished goods test reports were reviewed and found to meet the specification requirement.Attempts are being 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.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.The patient demographic info: age, gender, weight, bmi at the time of index procedure date of the index surgical procedure? what was the indication for bone wax use on the sternum? what was the sternum tissue condition, i.E., normal or thin, calcified, fragile, diseased? what was the onset date of symptoms from the initial surgical procedure? were any cultures performed? what are the results? how was the internal bacterial infection on the sternum diagnosed? how many days post-operatively was the bacterial infection identified? was medical intervention performed? if yes, please describe.Other relevant patient history/concomitant medications? if applicable, will product be returned, return date, tracking information? what is the physician¿s opinion as to the etiology of or contributing factors to this event? what is the patient¿s current status?.

Event Description

It was reported that patient underwent cabg procedure on an unknown date and bone wax was used.The patient experienced a bacterial infection on the sternum where the device was applied.The patient was treated with antibiotics and had prolonged hospitalization.Additional information has been requested.

Manufacturer Narrative

(b)(4).The product upon which this medwatch is based has been received, however, the product evaluation is not yet complete.Any further information derived from the evaluation will be submitted in a supplemental 3500a form.

Manufacturer Narrative

Product complaint # : (b)(4).Investigation summary: two intact complaint (reference) samples of product code w810 batch no b8036 were received for analysis.On physical verification products were found genuine.The complaint samples were tested for sterility as per usp guidelines & found complying to usp specification.Five retain samples of the incident code and lot number was retrieved for analysis.The primary packs of retain samples were visually inspected for attribute defects like pseudo seal, pin hole, product in seal, press marks on pack, damaged packs but no such defects were observed.The retain samples were tested for sterility as per usp guidelines & found complying to usp specification.The sterilization record for the product was found satisfactory indicating that the products have been sterilized adequately.The above analysis and device history record review shows that there was no issue related to processing of the lot.The sterility test of retain sample was found complying to usp specification.This review indicates that there was no quality concerns associated with the manufacturing process & sterilization process and the device is not likely related to the event.

• Brand Name: BONE WAX 2.5GR
• Type of Device: WAX, BONE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 8971950
• MDR Text Key: 156815715
• Report Number: 2210968-2019-86684
• Device Sequence Number: 1
• Product Code: MTJ
• 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: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 08/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2023
• Device Catalogue Number: W810
• Device Lot Number: B8036
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2019
• Initial Date Manufacturer Received: 08/12/2019
• Initial Date FDA Received: 09/06/2019
• Supplement Dates Manufacturer Received: 09/18/2019; 10/18/2019
• Supplement Dates FDA Received: 10/16/2019; 10/24/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention