MAUDE Adverse Event Report: DEPUY MITEK LLC US INTERMEDIARY TUBESET 24PK; SURGICAL IRRIGATION TUBING SET, GENERAL-PURPOSE

Model Number	281103
Medical Device Problem Code	Overfill (2404)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/25/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).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).
Event or Problem Description
It was reported by affiliate via personal interaction that during rotator cuff repair the inflow liquid through the inflow tubing passed over the fill chamber mark.As low pressure lamp blinked, they tried some troubleshooting such as draining and reconnecting the devices concerned, which did not correct the issue.Finally the inflow tubing and the intermediary tubing (281103) were replaced, which lead to the completion of the procedure without surgical delay.There was no harm to the patient.The devices are available to be returned for evaluation.Additional information received from the affiliate reported the devices are no longer available to be returned for evaluation.
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.H10 additional narrative: investigation summary = > the complaint device is not being returned, therefore unavailable for a physical evaluation.With the information provided, and without the complaint device to evaluate, we cannot determine a root cause for the reported failure.A manufacturing record evaluation was performed for the finished device lot number (5337), and no non-conformances were identified.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 history lot = > a manufacturing record evaluation was performed for the finished device lot number (5337), and no non-conformances were identified.

• Brand Name: INTERMEDIARY TUBESET 24PK
• Common Device Name: SURGICAL IRRIGATION TUBING SET, GENERAL-PURPOSE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 9940994
• Report Number: 1221934-2020-01112
• Device Sequence Number: 3696858
• Product Code: HRX
• UDI-Device Identifier: 10886705015764
• UDI-Public: 10886705015764
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K954465
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/25/2020

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 Expiration Date: 09/29/2020
• Device Model Number: 281103
• Device Catalogue Number: 281103
• Device Lot Number: 5337
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/25/2020
• Supplement Date Received by Manufacturer: 04/29/2020
• Initial Report FDA Received Date: 04/08/2020
• Supplement Report FDA Received Date: 04/29/2020
• Patient Sequence Number: 1