MAUDE Adverse Event Report: ETHICON INC. BONE WAX 12 X 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 Date 12/14/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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 that the patient underwent craniotomy procedure on (b)(6) 2019 and bone wax was used.The product was found hard after opening the foil and surgeon facing issue in the deployment and during the procedure.The procedure was delayed 30 minutes.Another device was used.There were no adverse patient consequences reported.

Manufacturer Narrative

Product complaint # (b)(4).Date sent to the fda: 02/19/2020.Additional information: d10, h6.Additional h3 device evaluation summary: an unopened sample of product code w31, lot al9149 was received for evaluation.During the visual inspection of the sample, no defects were observed on the packet, the sample was opened, and the appearance and consistency of the bonewax bar were conforming the requirements.The manufacturing records were reviewed, and the manufacturing/ packaging criteria were met prior to the release of this batch.According to samples condition, no appearance surface defects were noted.A manufacturing record evaluation was performed for the finished device al9149 number, and no non-conformances were identified.

• Brand Name: BONE WAX 12 X 2.5GRAMS
• Type of Device: WAX, BONE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 9566493
• MDR Text Key: 196400826
• Report Number: 2210968-2020-00214
• 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: foreign,user facility
• Type of Report: Initial,Followup
• Report Date: 12/14/2019

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: 02/28/2024
• Device Catalogue Number: W31C
• Device Lot Number: AL9149
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2020
• Initial Date Manufacturer Received: 12/14/2019
• Initial Date FDA Received: 01/08/2020
• Supplement Dates Manufacturer Received: 01/24/2020
• Supplement Dates FDA Received: 02/19/2020
• Patient Sequence Number: 1
• Patient Age: 56 YR
• Patient Weight: 90