MAUDE Adverse Event Report: ETHICON INC. BONEWAX 2.5 GR; WAX, BONE

Catalog Number W809T

Device Problem Melted (1385)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/03/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A manufacturing record evaluation was performed for the finished device w809t, lot ll7cdpm, and no non-conformances were identified.A photo of the product upon which this medwatch is based has been received, however, the photo evaluation is not yet complete.Any further information derived from the evaluation will be submitted in a supplemental 3500a form.Attempts are being 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 while storing the product the device melted out and was ejected from the packaging.The device was well-stored.There was no report that the device was used during a patient procedure and there were no adverse patient consequences reported.

Manufacturer Narrative

(b)(4).Date sent to the fda: 08/27/2019.A manufacturing record evaluation was performed for the finished device w809t, lot ll7cdpm, and no non-conformances were identified.Additional h3 investigation summary: it was received for analysis an opened box with unopened sample of product code w809, lot ll7cdpm.During the visual inspection of samples, folder was sticky.Since, the folder had adherent the bone wax.The folder was opened and the bone wax was totally melted.Therefore, the consistence of unit wax could not be determined.The manufacturing records were reviewed and the manufacturing/packaging criteria were met prior to the release of this batch.Due to condition of the sample received, it could not be determined what may have caused the reported incident of: ¿despite the fact that it was well-stored, it melted out, and it was ejected from the packaging".Additional h3 investigation summary: upon visual inspection of the picture, a sample damaged of product code w809 lot# ll7cdpm could be observed.However, no conclusion could be reach on how this happen.

• Brand Name: BONEWAX 2.5 GR
• Type of Device: WAX, BONE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 8850376
• MDR Text Key: 153125272
• Report Number: 2210968-2019-84998
• Device Sequence Number: 1
• Product Code: MTJ
• Combination Product (y/n): N
• 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: 07/04/2019

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: 03/31/2023
• Device Catalogue Number: W809T
• Device Lot Number: LL7CDPM
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2019
• Initial Date Manufacturer Received: 07/04/2019
• Initial Date FDA Received: 08/01/2019
• Supplement Dates Manufacturer Received: 08/13/2019
• Supplement Dates FDA Received: 08/27/2019
• Patient Sequence Number: 1