MAUDE Adverse Event Report: MEDTRONIC; MEDTRONIC YANKAUER IN MAJOR JOINT PACK-LF

Catalog Number	DYNJ0516998I
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/25/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that in the middle of an unknown orthopedic procedure, the tip of the yankauer suction broke off into the surgical site requiring retrieval by the surgeon through an unreported method.All pieces of the broken yankauer suction were reportedly successfully retrieved from the surgical site.No information was provided on the events that took place leading up to the break.General anesthesia was used; however, there was no report of any adverse patient consequence and no effect on the patient's stability as a result of the incident.No impact to the patient, the procedure, or the total length of the procedure was reported.There was no serious injury or follow-up care reported related to this event.Due to the reported incident and in an abundance of caution, this medwatch is being filed.The sample was not available to be returned for evaluation.A root cause cannot be determined at this time.If additional relevant information becomes available, a supplemental medwatch will be filed.
Event or Problem Description
It was reported that in the middle of an unknown orthopedic procedure, the yankauer tip broke off into surgical site.

• Common Device Name: MEDTRONIC YANKAUER IN MAJOR JOINT PACK-LF
• Manufacturer (Section D): MEDTRONIC; 710 medtronic parkway; minneapolis MN 55432 5604
• MDR Report Key: 7511468
• Report Number: 1423395-2018-00028
• Device Sequence Number: 16436556
• Product Code: OJH
• UDI-Device Identifier: 10889942072262
• UDI-Public: 10889942072262
• 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): 05/14/2018

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: DYNJ0516998I
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/02/2018
• Initial Report FDA Received Date: 05/14/2018
• 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
• Patient Age: 74 YR