MAUDE Adverse Event Report: STERILMED, INC.; ARTHROSCOPE

Model Number	SMI7205305
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/18/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Surgeon was performing a shoulder arthroscopy when he entered the shoulder with the power shaver and noticed the shaver blade to be scratched and dented.Surgeon asked or team if shaver blade was a refurbished blade.Circulator confirmed that the shaver was refurbished.Circulator obtained a brand new shaver blade from shelf and switched out the shaver blades.

• Brand Name: NA
• Common Device Name: ARTHROSCOPE
• Manufacturer (Section D): STERILMED, INC.; 5010 cheshire pkwy n ste 2; plymouth MN 55446
• MDR Report Key: 8878747
• Report Number: 8878747
• Device Sequence Number: 216281
• Product Code: HRX
• UDI-Device Identifier: 10888551041607
• UDI-Public: (01)10888551041607
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 07/22/2019
• Report Date (Section F): 07/22/2019

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 Model Number: SMI7205305
• Device Catalogue Number: SMI7205305
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 08/09/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/09/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Weight: 115
• Date Report Sent to FDA: 07/22/2019