MAUDE Adverse Event Report: SMITH & NEPHEW, INC. REAMER QUICK CONNECT; PRSTH,HP,SM-CNSTR,MTL/CRM/PLY,CMN R N-PRS,UNCMN

Model Number 71355094

Device Problem Contamination /Decontamination Problem (2895)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/26/2019

Event Type  malfunction  

Event Description

It was reported that before surgery, while setting up for the case, it was difficult to connect the reamer quick connect handle to the distal reamer, a second handle (back up) was used but the same issue was found with this instrument.After a gentle tap of the handles on the edge of the tray to help loosen the shaft, large shards of dried blood fell from the device into the tray of reamers (tray was deemed unsterile).A competitor¿s device was used to complete the surgery, no patient injury was reported.

Manufacturer Narrative

The devices, intended for use in treatment, were not returned for evaluation.A visual inspection of the provided pictures confirmed the stated failure mode.The devices had visible biological contamination on the connection end, after sliding back the locking sleeve.A complaint history review found related failures; this failure mode will be monitored for future complaints and assessed for any necessary corrective actions.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.The device passed clean ability 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.These devices are considered devices with challenging design features in our cleaning instructions as they may have retractable and moving features.The potential probable cause of this event is likely inadequate cleaning.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.Should the devices or additional information be received, the complaints will be reopened.No further investigation warranted for these complaints; however, we will continue to monitor for future complaints and investigate as necessary.

• Brand Name: REAMER QUICK CONNECT
• Type of Device: PRSTH,HP,SM-CNSTR,MTL/CRM/PLY,CMN R N-PRS,UNCMN
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9580283
• MDR Text Key: 177240345
• Report Number: 1020279-2020-00226
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 00885556223093
• UDI-Public: 00885556223093
• Combination Product (y/n): N
• PMA/PMN Number: K113789
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 04/14/2020

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
• Device Operator: Health Professional
• Device Model Number: 71355094
• Device Catalogue Number: 71355094
• Device Lot Number: 17GSC0001
• Initial Date Manufacturer Received: 12/26/2019
• Initial Date FDA Received: 01/13/2020
• Supplement Dates Manufacturer Received: 04/02/2020
• Supplement Dates FDA Received: 04/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1