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 01/01/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device history records were reviewed and the manufacturing criteria was met prior to the release of this lot.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.

Event Description

It was reported that a patient underwent an unknown neurological procedure on an unknown date and bone wax was used.During the procedure, the bone wax was not sticking to the bone.As they were applying it, it was simply coming off as they move along the bone.The procedure was completed with a different device.There were no adverse patient consequences reported.

Manufacturer Narrative

(b)(4).An unopened sample of product code w31, lot # al1661 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.According to samples condition, no performance nonadherence were noted.A manufacturing record evaluation was performed for the finished device al1661 number, and no non-conformances were identified.

• 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: 8468898
• MDR Text Key: 140434520
• Report Number: 2210968-2019-79829
• 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
• Report Date: 03/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2023
• Device Catalogue Number: W31C
• Device Lot Number: AL1661
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/08/2019
• Date Manufacturer Received: 04/11/2019
• Patient Sequence Number: 1