MAUDE Adverse Event Report: SMITH & NEPHEW, INC. REAMER QUICK CONNECT; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Catalog Number 71355094

Device Problem Contamination /Decontamination Problem (2895)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/29/2019

Event Type  malfunction  

Event Description

It was reported that even after multiple cleaning by the spd staff still contain bio-burden.The instruments appear to be clean, but after working the spring mechanism up and down it reveals debris.A delay greater than 30 min was reported.No backup device not available.

Manufacturer Narrative

The associated quick connect reamers were returned and evaluated.A visual inspection of the photo attached to the complaint confirms some debris found inside the devices.These devices were manufactured in 2017.The part passed cleanability testing in 2011 and should therefore be able to be cleaned per the validated cleaning process outlined in instructions for care, maintenance, cleaning and sterilization of smith and nephew orthopaedics devices.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.

• Brand Name: REAMER QUICK CONNECT
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9119342
• MDR Text Key: 160051254
• Report Number: 1020279-2019-03479
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 00885556223093
• UDI-Public: 00885556223093
• Combination Product (y/n): N
• PMA/PMN Number: K113769
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 01/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 71355094
• Device Lot Number: 17FSC0012
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2019
• Date Manufacturer Received: 08/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1