MAUDE Adverse Event Report: STERILMED, INC.; ARTHROSCOPE

Model Number	LINC9255
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/14/2020
Type of Reportable Event	Malfunction
Event or Problem Description
The sterilmed shaver blade broke during an orthopedic procedure.As a result, a new shaver was opened to complete the original intended procedure.

• Brand Name: NA
• Common Device Name: ARTHROSCOPE
• Manufacturer (Section D): STERILMED, INC.; 11400 73rd ave n ste 100; maple grove MN 55369
• MDR Report Key: 10390171
• Report Number: 10390171
• Device Sequence Number: 17061056
• Product Code: HRX
• UDI-Device Identifier: 10888551000222
• UDI-Public: (01)10888551000222
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/27/2020
• Report Date (Section F): 07/27/2020

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 Model Number: LINC9255
• Device Catalogue Number: LINC9255
• Device Lot Number: 2117891
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 08/11/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 103
• Date Report Sent to FDA: 07/27/2020