MAUDE Adverse Event Report: DEPUY MITEK LLC US I/O FLOW SHEATH-S&N; RIGID ENDOSCOPE SHEATH

Model Number	218019
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/31/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Occupation: initial reporter is a mitek sales representative.Investigation summary: despite multiple attempts made to the sales representative for the return of the complaint device, the device has not been received back for evaluation.This complaint cannot be confirmed.No further information regarding the cause of the defect has been provided to help determine a root cause for this failure.The lot number was not reported therefore a device history record (dhr) review could not be conducted.Also, a review into the depuy synthes mitek complaints system is not possible.We cannot discern a root cause for the reported failure mode.At this point in time, no corrective action is required, and no further action is warranted.However, depuy synthes mitek will continue to track any related complaints within this device family as a means of monitoring the extent with which this complaint is observed in the field.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
It was reported that the customer's fms inflow outflow sheath kit was leaking prior to a rotator cuff repair while setting up for the case.The case was completed using another like device.There were no patient consequences or delays.The device is being returned.This report is for a fms inflow outflow sheath kit.This is report 1 of 1 for (b)(4).

• Brand Name: I/O FLOW SHEATH-S&N
• Common Device Name: RIGID ENDOSCOPE SHEATH
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 8988834
• Report Number: 1221934-2019-58244
• Device Sequence Number: 2922277
• Product Code: NBH
• UDI-Device Identifier: 10886705023721
• UDI-Public: (01)10886705023721
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 218019
• Device Catalogue Number: 218019
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/31/2017
• Initial Report FDA Received Date: 09/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1