MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; YANKAUER FLANGED TIP W/O VENT

Catalog Number	DYNJ0923000
Health Effect - Clinical Code	No Information (3190)
Date of Event	11/06/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that the surgeon was performing a shoulder surgery and using the yankauer as a retractor during the case.The facility reported that the tip of the yankauer broke off and the staff was not able to locate the tip.Numerous attempts have been made to attempt to contact the facility to obtain additional information related to the incident with no response.The base of the device was returned for evaluation and showed 1 ½ inches had broken off of the shaft.The damage was from the tip down the shaft before the angled bend.The break was irregular and jagged indicating the break was caused by force or trauma.No additional information is available.Due to the reported incident and in abundance of caution this medwatch is being filed.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that the tip of a yankauer device broke off during a procedure.

• Common Device Name: YANKAUER FLANGED TIP W/O VENT
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 7111516
• Report Number: 1423395-2017-00029
• Device Sequence Number: 16537737
• Product Code: JOL
• UDI-Device Identifier: 10889942099627
• UDI-Public: 10889942099627
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 12/12/2017

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: DYNJ0923000
• Device Lot Number: 17HB6900
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/27/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/13/2017
• Initial Report FDA Received Date: 12/12/2017
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention