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

Catalog Number	OR87TRG
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/20/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that during a total hip procedure, the yankauer was identified to be missing its tip.The reporting facility was unable to indicate if the reported break of the yankauer tip occurred during first use of the device or how the yankauer was being used prior to identifying the reported issue.Reportedly, at the time of the incident, the staff believed that the tip had fallen into the surgical site.The surgical site was reportedly searched and an x-ray was obtained but the yankauer tip could not be located.The patient was under general anesthesia at the time of the incident.No additional anesthesia was required.No impact to the procedure was reported.The reporting facility indicated that there was no serious injury or follow-up care related to the reported incident.A sample was returned to the manufacturer for evaluation and, at this time, sample investigation is ongoing.Due to the reported incident, and in an abundance of caution, this medwatch is being file.A supplemental medwatch will be filed upon completion of the sample investigation and/or if additional relevant information becomes available.
Event or Problem Description
It was reported that during a total hip procedure, the yankauer was identified to be missing its tip.
Additional Manufacturer Narrative
The yankauer involved in the reported incident was not returned for evaluation.Unused samples from the same lot were returned by the reporting facility and investigation was completed on 31-jan-2019.Visual inspection of the unused samples was performed and no issues were observed.Dimensional inspection was performed and the unused samples were found to match product specifications.A root cause for the reported incident could not be determined.If additional relevant information becomes available another supplemental medwatch will be filed.

• Common Device Name: YANKAUER, OPEN TIP, W/O VENT, STERILE
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093 2753
• MDR Report Key: 8282443
• Report Number: 1417592-2019-00007
• Device Sequence Number: 2463321
• Product Code: JOL
• UDI-Device Identifier: 10888277657335
• UDI-Public: 10888277657335
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,Followup
• Report Date (Section B): 01/02/2019

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: Health Professional
• Device Catalogue Number: OR87TRG
• Device Lot Number: 18318040001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2019
• Initial Date Received by Manufacturer: 01/04/2019
• Supplement Date Received by Manufacturer: 01/04/2019
• Initial Report FDA Received Date: 01/28/2019
• Supplement Report FDA Received Date: 02/01/2019
• 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: Other; Required Intervention
• Patient Age: 58 YR