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

Model Number	284504
Medical Device Problem Code	Residue After Decontamination (2325)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/12/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Udi: (b)(4).Investigation summary: according to the information provided, it was reported that noticed tubing was split when connected to machine, packaging was intact.The complaint device was received and evaluated.Visual inspection reveals that the tubing was received complete with residues of saline water.In addition, the tubing was found cracked close to the clamp set.The functional test was not performed due to damages in the tubing.The complaint can be confirmed.As mentioned in the information provided, the root cause for the reported failure can be related to the tear at the level of the injection roller when the device is put in place.However, it cannot be conclusively affirmed.  a manufacturing record evaluation was performed for the finished device lot number:6346, and no non-conformance's 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.
Event or Problem Description
It was reported by the affiliate in (b)(6) that preoperatively to a arthroscopic subacromial decompression (asad) procedure, it was observed that the tubing was split when connected to machine while the packaging was intact.During in-house engineering evaluation, it was determined that the tubing had residues of saline water.There was no delay in the surgery due to the event.Another set of tubing was used to complete the surgery.There were no adverse patient consequences to the patient.No additional information was provided.

• Brand Name: IRRIGATION 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: 10726441
• Report Number: 1221934-2020-03183
• Device Sequence Number: 3457440
• Product Code: HRX
• UDI-Device Identifier: 10886705017393
• UDI-Public: 10886705017393
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K951843
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/11/2020

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: 04/29/2021
• Device Model Number: 284504
• Device Catalogue Number: 284504
• Device Lot Number: 6346
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/15/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/11/2020
• Initial Report FDA Received Date: 10/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1