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 Date 12/17/2018

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).A review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.To date, the device has not been returned.If the product is returned for evaluation, any further information derived from the evaluation will be submitted in a supplemental 3500a form.

Event Description

It was reported that a patient underwent a craniotomy procedure (b)(6) 2019, and bone wax was used.The surgeon opened the bone wax to apply onto the skull to stop the bone bleeding.The bone wax did not stick on the bone.It was reported that the bone was softer than previous bone wax.Since the product didn¿t adhere to the bone bleeding side, it didn't stop the bleeding.The surgeon then opened a pack of different batch of bone wax to apply on the bleeding side (skull).The procedure was completed successfully.Additional information was requested.

Manufacturer Narrative

Product complaint # (b)(4).Date sent to the fda: 02/13/2019.Additional information: concomitant medical products.Device evaluation: an opened box with eleven unopened samples of product were returned for analysis.During the visual inspection of eleven unopened samples, no defects were observed on the packets.The samples were opened and contained a bone wax in folder.The bone wax was examined, and the consistency of the wax was uniform and smooth, the appearance of wax is correct.A functional test was performed on the bone waxes and met the requirements.The manufacturing records were reviewed and the manufacturing/packaging criteria were met prior to the release of this batch.Per the condition of the sample received, no performance non-adherence was observed and the reported complaint could not be confirmed.

• 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
• MDR Report Key: 8243069
• MDR Text Key: 133058585
• Report Number: 2210968-2019-78371
• 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,health professional
• Type of Report: Initial,Followup
• Report Date: 12/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 09/30/2022
• Device Catalogue Number: W31C
• Device Lot Number: AJ7530
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2019
• Date Manufacturer Received: 01/23/2019
• Patient Sequence Number: 1