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

Catalog Number	218021
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/23/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.(b)(4).Investigation summary: the complaint device was discarded and not available for evaluation.No further information regarding the technique or instruments used has been provided to determine a root cause for this failure.A dhr review has been conducted and the results indicate that this batch of product was processed without any incident and therefore there is no evidence of manufacturing anomalies on the paperwork reviewed.Therefore, we cannot determine what caused the user to experience the reported event, 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, should any new information be provided in future, this file will be re-opened, and a thorough investigation will be performed.Depuy 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.This report is being filed as required under mitek's corrective and preventative actions (capa) to file usa fda mdr missed malfunctions.
Event or Problem Description
It was reported by the sales rep the during a shoulder procedure the o-rings on the customer's inflow/outflow sheath kit stryker are weak and causing the device to leak.The procedure was completed with another like device with no harm to the patient or delays to the case.The sales rep stated that the device was discarded by the customer.There was no delay in the surgical procedure.There was a spare device available for use to complete the surgery.There was patient involvement.There were no reports of injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.

• Brand Name: I/O FLOW SHEATH-STRYKER
• Common Device Name: RIGID ENDOSCOPE SHEATH
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 9039850
• Report Number: 1221934-2019-58315
• Device Sequence Number: 16864638
• Product Code: NBH
• UDI-Device Identifier: 10886705023745
• UDI-Public: 10886705023745
• 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,other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/23/2018

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 Catalogue Number: 218021
• Device Lot Number: 151001
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/23/2018
• Initial Report FDA Received Date: 09/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1