MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; WAX,BONE,NATURAL

Catalog Number	DYNJBW25
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/01/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported that at the beginning of a sternotomy procedure a piece of the bone wax broke off into the surgical site.Reportedly, the surgeon was required to remove the bone wax from the surgical site via an unidentified method.The patient was under general anesthesia at the time of the incident.The procedure did not last longer than expected and the patient did not require additional anesthesia to complete the procedure.No impact to the patient reported.No impact to the procedure reported.No sample was returned to the manufacturer for evaluation.No additional information was provided to the manufacturer.Due to the need for medical intervention to remove the bone wax from the surgical site, and in an abundance of caution, this medwatch is being filed.If additional relevant information becomes available a supplemental medwatch will be filed.
Event or Problem Description
It was reported that at the beginning of a sternotomy procedure a piece of the bone wax broke off into the surgical site.

• Common Device Name: WAX,BONE,NATURAL
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 7586478
• Report Number: 1417592-2018-00051
• Device Sequence Number: 2195472
• Product Code: MTJ
• UDI-Device Identifier: 10080196024216
• UDI-Public: 10080196024216
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Catalogue Number: DYNJBW25
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/24/2018
• Initial Report FDA Received Date: 06/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention