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	04/13/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported that during a left total shoulder procedure, the yankauer tip broke off and fell into the surgical site.This incident reportedly occurred during "regular use" of the device.The or staff was required to search the surgical site and visually retrieve the broken yankauer tip pieces.No information was provided to the manufacturer as to what instruments were used during the retrieval process or how many yankauer tip pieces were retrieved from the surgical site.The patient was under general anesthesia at the time of this incident.Reportedly, the procedure lasted longer than expected but the patient did not require additional anesthesia.No impact to patient stability reported.No serious injury, additional medical intervention, or follow-up care reported.No sample was returned to the manufacturer for evaluation.Due to the reported incident, 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 during a left total shoulder procedure, the yankauer tip broke off and fell into the 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: 7507107
• Report Number: 1423395-2018-00026
• Device Sequence Number: 19145983
• 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): 05/11/2018

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: DYNJ0516998I
• Device Lot Number: 17LK2807
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/26/2018
• Initial Report FDA Received Date: 05/11/2018
• 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
• Patient Age: 73 YR