MAUDE Adverse Event Report: MEDTRONIC; MEDTRONIC YANKAUER IN ANTERIOR TOTAL HIP PACK-LF

Catalog Number	DYNJ0984486G
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/25/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported that during an unidentified left hip procedure, the yankauer tip broke off and fell into the surgical site.The facility reported that this incident occurred in the middle of the procedure and that the or staff was required to "investigate and find broken pieces" for retrieval.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 facility reported "no guarantee that all pieces retrieved." the patient was under general anesthesia at the time of this incident.No impact to the patient, the patient's stability, to the procedure, or to the total length of the procedure was reported.No information was received regarding the events that took place leading up to the reported yankauer tip break and if this break occurred during normal use of the device.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 is an mdr reportable event.If additional relevant information becomes available, this report will be reopened and reevaluated.
Event or Problem Description
It was reported that during an unidentified left hip procedure, the yankauer tip broke off and fell into the surgical site.

• Common Device Name: MEDTRONIC YANKAUER IN ANTERIOR TOTAL HIP PACK-LF
• Manufacturer (Section D): MEDTRONIC; 710 medtronic parkway; minneapolis MN 55432 5604
• MDR Report Key: 7507942
• Report Number: 1423395-2018-00027
• Device Sequence Number: 13507365
• Product Code: OJH
• UDI-Device Identifier: 10889942552702
• UDI-Public: 10889942552702
• 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: DYNJ0984486G
• Device Lot Number: 18AK0679
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/25/2018
• 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: 74 YR