MAUDE Adverse Event Report: ETHICON INC. BONE WAX 12 X 2.5GRAMS; WAX, BONE

Catalog Number W31C

Device Problem Contamination /Decontamination Problem (2895)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/26/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.Additional evaluation summary: only a picture was returned for analysis.Upon visual inspection of the picture, an opened sample with a hair inside of the folder could be observed.However, no conclusion could be reached on how this happened as the sample has not returned for analysis.

Event Description

It was reported that a patient underwent an unknown procedure on (b)(6) 2019 and bone wax was used.Preoperatively, it was noticed that there was a hair in the package.There were no adverse patient consequences reported.

Manufacturer Narrative

Product complaint #: (b)(4).Additional evaluation summary: one open sample of product code: w31, lot: al6502 was received for analysis.According to the information received, the customer encountered a hair in the bone wax product.A picture was received along with the actual sample.Upon visual inspection of the opened sample foreign matter that resembled a hair was noted to be embedded on the bone wax.Microscopic examination was conducted, and no conclusion could be reached as the foreign matter was partially covered by the wax.The sample was analyzed in the microbiology lab using infrared spectroscopy (ftir) and results suggest that the foreign material is biological source, presumably human hair.The manufacturing records were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch.

• 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: 9453651
• MDR Text Key: 180898822
• Report Number: 2210968-2019-90764
• 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: 12/02/2019

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: No Information
• Device Expiration Date: 12/31/2023
• Device Catalogue Number: W31C
• Device Lot Number: AL6502
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/01/2019
• Initial Date FDA Received: 12/11/2019
• Supplement Dates Manufacturer Received: 12/08/2019
• Supplement Dates FDA Received: 12/27/2019
• Patient Sequence Number: 1