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

Catalog Number W810T

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

Patient Problems Impaired Healing (2378); Fluid Discharge (2686); Not Applicable (3189)

Event Date 06/01/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).A manufacturing record evaluation was performed for the finished device lot number am9633, and no non conformances / manufacturing irregularities related to the malfunction were identified.To date the device has not been returned.If the device or further details are received at the later date a supplemental medwatch will be sent.Attempts are being made to clarify 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: weight, bmi at the time of index procedure diagnosis and name of index surgical procedure? where and how in the patient¿s body was the bone wax placed? did the operating surgeon observe any device deficiency or anomaly before, during, after the bone wax placement and during any re-operation? other relevant patient history/concomitant medications? what was indication for debridement? what is physician¿s opinion as to the etiology of or contributing factors to these events? what is the patient current status after complete bone wax removal?.

Event Description

It was reported that the patient underwent an unknown bilateral top drilling drainage surgery on (b)(6) 2020 and bone wax was used.Following the procedure, on (b)(6) 2020, the patient experienced poor wound healing and wound secretion.Partial of bone wax was removed on (b)(6) 2020 while dressing change was given to the patient.The bone wax was removed completely in the surgery of debridement of right top incision on (b)(6) 2020.Additional information has been requested.

• Brand Name: BONE WAX
• Type of Device: STERILE NONABSORBABLE BONE WAX
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• Manufacturer (Section G): ETHICON INC.-BRAZIL; rodovia presidente dutra; km 154; sao paolo 12240 ; BR 12240
• Manufacturer Contact: elba bello ; p.o. box 151, route 22 west; somerville, NJ 08876 ; 9082183429
• MDR Report Key: 10252832
• MDR Text Key: 198330565
• Report Number: 2210968-2020-05170
• 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: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: W810T
• Device Lot Number: AM9633
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/24/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/05/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 52 YR