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

Model Number	281103
Medical Device Problem Codes	Crack (1135); Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/15/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Udi: (b)(4).To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.
Event or Problem Description
It was reported by the affiliate in (b)(6) that during an arcr (arthroscopic rotator cuff repair) treating rotator cuff tear on (b)(6) 2020, it was observed that the connecting part of the tubing was broken that there was fluid leaking from it.The broken area was cut to complete the procedure with less than 30 minutes of delay.There were no adverse patient consequences reported.No additional information was provided.The device was band new and the first use when the issue occurred.
Additional Manufacturer Narrative
This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by mitek or its employees that the report constitutes an admission that the device, mitek, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Investigation summary: according to the information received, it was reported that during an arcr (arthroscopic rotator cuff repair) treating rotator cuff tear.Only inflow system was used during the procedure.It was found approximately 30 minutes from the beginning of the procedure that fluid leaked from the tubing.They found that the connecting part of the tubing had broken.They cut the broken area and completed the rest the procedure with the tubing in question less than 30-minute surgical delay.The device was band new and the first use when the issue occurred.The complaint device is not being returned, it was discarded by the customer, therefore unavailable for a physical evaluation.However, photos were provided.Upon visual inspection of the photos, it should be noted that the connecting part was broken.A manufacturing record evaluation was performed for the finished device lot number:[7228], and no nonconformances were identified.The event described could be confirmed as the photos showed evidence of the damage found on the tubing; therefore it was not functioning properly.The possible root cause can be attributed to the heavy use while trying to connect in the connection point.However, it cannot be conclusively affirmed.At this point in time, no corrective action is required, and no further action is warranted.However, in depuy synthes mitkek, additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post market surveillance.

• 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: 11089788
• Report Number: 1221934-2020-04136
• Device Sequence Number: 11653100
• 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/15/2020

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: 10/31/2021
• Device Model Number: 281103
• Device Catalogue Number: 281103
• Device Lot Number: 7228
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/15/2020
• Supplement Date Received by Manufacturer: 01/14/2021
• Initial Report FDA Received Date: 12/29/2020
• Supplement Report FDA Received Date: 01/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1