MAUDE Adverse Event Report: STERILMED, INC. SHAVER BLADE STERLING CUDA LARGE HUB MAGENTA; ARTHROSCOPE

Model Number	LINC9255
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/14/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Since no device has been received for analysis, no product investigation can be performed, and the customer complaint cannot be confirmed.A manufacturing record evaluation (mre) was conducted and there were no identified internal actions.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).
Event or Problem Description
It was reported that a patient underwent an acl (ant.Cruciated ligament) procedure with a shaver blade sterling cuda large hub magenta and the issue of an unknown part of the device broke inside of the patient occurred.During the procedure while under general anesthesia, the shaver blade sterling cuda large hub magenta broke.The device was used for a right knee arthroscopy, medial meniscus repair and right knee acl reconstruction, patellar tendon autograft.A new shaver was opened to complete the procedure.There was no patient consequence reported.The issue reported was assessed as mdr reportable as an unknown part of the device broke inside of the patient.

• Brand Name: SHAVER BLADE STERLING CUDA LARGE HUB MAGENTA
• Common Device Name: ARTHROSCOPE
• Manufacturer (Section D): STERILMED, INC.; 5010 cheshire parkway; ste 2; plymouth MN 55446
• MDR Report Key: 10420286
• Report Number: 2134070-2020-00006
• Device Sequence Number: 19522345
• Product Code: HRX
• UDI-Device Identifier: 10888551000222
• UDI-Public: 10888551000222
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K012536
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/20/2020

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 Expiration Date: 04/17/2021
• Device Model Number: LINC9255
• Device Catalogue Number: LINC9255
• Device Lot Number: 2117891
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/20/2020
• Initial Report FDA Received Date: 08/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1