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

Catalog Number	284610
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/12/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: the complaint device was received and inspected.Visual inspection confirms part of tubing is cracked.The complaint can be confirmed.This failure mode has been observed when the tubing is not seated properly on the roller and once secured, it cracks the tubing and cause leakage.This failure has been attributed to mishandling of the device, a user issue.This complaint is approximately 371 days old and despite attempts by mitek customer quality and affiliate business quality to get additional information, none has been made available.Based off the information available to mitek customer quality, there is no patient risk or consequences.This complaint file is being closed, should any new information be received in the future, this file will be reopened at that time and updated to reflect the information received.A dhr review has been conducted to determine if there were any internal processing issues which would have contributed to the nature of the product complaint.Our results indicate that this batch of product was processed without incident and therefore there is no evidence of manufacturing anomalies on the paperwork reviewed.Further, a review into the depuy synthes mitek complaints system revealed no other complaints of any type for this lot of devices that were released to distribution.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.(b)(4).Associated medwatch: 1221934-2018-50524.
Event or Problem Description
The affiliate reported via email that product "burst" during the surgery that happened on (b)(6) 2017.It is unknown until this moment if both products burst or just one.We are verifying this information yet.Additional information received via email from the affiliate on 5-16-2017.Type of procedure is unknown, this information was sent to the sales rep to verify.It is unknown if the split in the tubing is where the tubing is placed on the roller, this information was sent to the sales rep.To verify.It is unknown if the photo was for one tubing or both, this information was sent to the sales rep.Verify.Another product that was available in the hospital was used to complete the procedure.There was no delay.There were no patient consequences.

• Brand Name: DISP PATIENT SET FMS 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: 7455807
• Report Number: 1221934-2018-50522
• Device Sequence Number: 10964239
• Product Code: HRX
• UDI-Device Identifier: 10886705023226
• UDI-Public: 10886705023226
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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: Health Professional
• Type of Report: Initial
• Report Date (Section B): 04/12/2017

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 Expiration Date: 09/30/2017
• Device Catalogue Number: 284610
• Device Lot Number: 382
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2017
• Initial Date Received by Manufacturer: 04/12/2017
• Initial Report FDA Received Date: 04/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1