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

Catalog Number W31G

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Blood Loss (2597); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Conclusion: to date, the device has not been returned.If the product is returned for evaluation, any further info derived from the evaluation will be submitted in a supplemental 3500a form.In addition, a review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.

Event Description

It was reported that the patient underwent a craniotomy procedure on unknown date and bone wax was used.It was also reported that the use of bone wax resulted in post- operative brain bleeds requiring additional surgery.Additional information has been requested.

Manufacturer Narrative

It was reported that the patient underwent a craniotomy procedure on unknown date and bone wax was used for control of bone bleeding and to seal air cells in the petrous bone to reduce chance of csf leak.It was also reported by the doctor that no brain bleed occurred.The doctor opined that the re-operation to repair csf leak was required due to the sub-optimal adherence of the wax to the bone and its failure to stay in place allowing the csf leak to occur.At the time of re-operation the previously placed bone wax was dry, brittle, loosely attached to the bone.The patient is doing well currently.(b)(4).

Manufacturer Narrative

Conclusion : representative sample was returned for evaluation.It was visually and functionally examined for wax adhesion and consistency and it met the requirements.

• Brand Name: BONE WAX
• 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 1; 54; sao paolo 12240 -908; BR 12240-908
• Manufacturer Contact: guillermo villa ; route 22 west po box 151; somerville, NJ 08876 ; 9082180707
• MDR Report Key: 5264460
• MDR Text Key: 32615411
• Report Number: 2210968-2015-19512
• 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,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 11/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2020
• Device Catalogue Number: W31G
• Device Lot Number: AA3567
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2015
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/19/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/30/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention