MAUDE Adverse Event Report: STRYKER CORPORATION HUDSON; INSTRUMENT, SURGICAL, ORTHOPEDIC, DC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Model Number 6203-135

Device Problem Failure to Clean Adequately (4048)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/01/2018

Event Type  malfunction  

Event Description

Stryker hudson modified trinkle (part# 6203-135) is difficult to decontaminate because of the design.

• Brand Name: HUDSON
• Type of Device: INSTRUMENT, SURGICAL, ORTHOPEDIC, DC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
• Manufacturer (Section D): STRYKER CORPORATION; 2825 airview blvd.; portage MI 49002
• MDR Report Key: 8277169
• MDR Text Key: 134084228
• Report Number: 8277169
• Device Sequence Number: 1
• Product Code: KIJ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 01/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 6203-135
• Device Catalogue Number: -
• Device Lot Number: -
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/03/2019
• Event Location: Hospital
• Date Report to Manufacturer: 01/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1