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

Catalog Number 281142

Device Problem Overfill (2404)

Patient Problems Edema (1820); Extravasation (1842)

Event Date 07/24/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Investigation summary: the complaint device is not being returned, therefore is unavailable for a physical evaluation.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.Therefore, we cannot determine what caused the user to experience the reported event, we cannot discern a root cause for the reported failure mode.A review into the mitek complaints system revealed no other complaint of any kind for this lot of devices.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.Udi: (b)(4).Associated medwatch: 1221934-2018-52439.

Event Description

The affiliate reported via email during the arthroscopic procedure the pump presented failure as the reservoir was completely filled, the pressure was lowered to 0 and the filter was wet.This caused discomfort in the surgeon who decided to turn off the pump and pass water directly from the bags.No patient consequences.Additional information received from the affiliate via e-mail on 12-26-2017: the device is not coming back.The failure occurs during the procedure, when the reservoir fills completely, the pressure drops to zero, causing the visual field to fill with blood and the shoulder to have severe edema.The surgical delay was about 45 minutes, while i tried to remove the water from the hoses and connect them again, having the same result.We had to pass equipment in y to pass the water directly.The procedure was completed but the surgeon was upset about what happened.When i say that the water is passed directly, i refer to the passage of water through y equipment and exerting pressure on the water bags to improve the vision of the surgical field.The patient was shoulder edema due to not having a controlled pressure during the surgery.

• Brand Name: INTERMED TUBESET SCHKVLVE 24PK
• Type of Device: SURGICAL IRRIGATION TUBING SET, GENERAL-PURPOSE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: jennifer lawrence ; 325 paramount drive; raynham, MA 02767 ; 5088808100
• MDR Report Key: 7639077
• MDR Text Key: 112373863
• Report Number: 1221934-2018-52463
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 10886705015900
• UDI-Public: 10886705015900
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K951843
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2018
• Device Catalogue Number: 281142
• Device Lot Number: 1901
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/24/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/21/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other