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

Catalog Number	71355094
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/29/2019
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional 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
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9119342
• Report Number: 1020279-2019-03479
• Device Sequence Number: 2334461
• Product Code: LIT
• UDI-Device Identifier: 00885556223093
• UDI-Public: 00885556223093
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K113769
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/02/2020

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 Catalogue Number: 71355094
• Device Lot Number: 17FSC0012
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2019
• Initial Date Received by Manufacturer: 08/29/2019
• Supplement Date Received by Manufacturer: 08/29/2019
• Initial Report FDA Received Date: 09/25/2019
• Supplement Report FDA Received Date: 01/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1