MAUDE Adverse Event Report: ETHICON INC. BONE WAX 275 X 2.5GRAMS; WAX, BONE

Model Number	DW31B
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/27/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint: (b)(4).Attempts are being made to receive a device.To date the device has not been returned.If the device or further details are received at the later date a supplemental medwatch will be sent.
Event or Problem Description
It was reported that the patient underwent a craniotomy on (b)(6) 2020 and the bonewax was used.It was also reported that a hair was found on the bone was when the pack was opened.There were no adverse consequences for the patient.
Additional Manufacturer Narrative
(b)(4).Date sent to the fda: 09/16/2020.A manufacturing record evaluation was performed for the finished device lot number am3945, and no non conformances / manufacturing irregularities were identified.Additional h3 investigation summary: it was reported foreign matter biological.One picture was received for analysis.Upon visual inspection of the picture, a foreign matter (hair) appears to be inserted on a wax of product code dw31b, lot am3945 could be observed.However, no conclusion could be reach as the sample was not returned for analysis.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon inc, or its employees that the report constitutes an admission that the product, ethicon inc or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: BONE WAX 275 X 2.5GRAMS
• Common Device Name: WAX, BONE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 10411381
• Report Number: 2210968-2020-06144
• Device Sequence Number: 16894312
• Product Code: MTJ
• UDI-Device Identifier: 10705031036826
• UDI-Public: 10705031036826
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: PRE-AMEND
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/31/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2024
• Device Model Number: DW31B
• Device Catalogue Number: DW31B
• Device Lot Number: AM3945
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/31/2020
• Supplement Date Received by Manufacturer: 08/26/2020
• Initial Report FDA Received Date: 08/14/2020
• Supplement Report FDA Received Date: 09/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1