MAUDE Adverse Event Report: STERILMED, INC.; ARTHROSCOPE

Model Number	STR375-951-100
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/03/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not yet been returned to the manufacturer at the time of this report.A supplemental form will be sent once the evaluation is completed if the device is returned.The device history report was reviewed and no discrepancies were found.
Event or Problem Description
It was reported that two shaver devices shed shavings within the patient during a procedure.All traces were removed from the patient and no patient harm or consequences occurred.
Additional Manufacturer Narrative
The customer returned two shavers that were sent together in a bag without protective materials to prevent the devices from rubbing against each other or being damaged.Additional clarifying information regarding the event and the identity of the included devices was not provided.The device with 2 reprocessing marks was examined under magnification for purposes of this investigation id.There are biological contaminants still present on the cutting area of the bur shaver.There is notable wear of the cutting edges, the two parts were reassembled together and the drop/spin test was performed.While the account's accompanying photos support their reported issue, there is no confirmed metal shavings collected from this device.The instructions for use (b)(4) does state that - do not contact cutters, shavers, or burrs with metal objects as this may cause the device to break or shed metal.Excessive ¿side-loading¿ on the blade during use does not improve cutting performance, and in extreme cases, may result in wear and degradation of the inner blade.Excessive pressure may cause cutters, shavers, or burrs to bend or break which may in turn cause harm to the patient and / or operating room staff.The damage that the shavers incurred appears that it may have been a result of misuse in the field.

• Brand Name: NA
• Common Device Name: ARTHROSCOPE
• Manufacturer (Section D): STERILMED, INC.; 11400 73rd ave n; maple grove MN
• MDR Report Key: 6618096
• Report Number: 2134070-2017-00013
• Device Sequence Number: 18835294
• Product Code: HRX
• UDI-Device Identifier: 10888551030113
• UDI-Public: 011088855103011317170708101953700
• 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
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/09/2017

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: 06/27/2017
• Device Model Number: STR375-951-100
• Device Catalogue Number: STR375-951-100
• Device Lot Number: 1953700
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/09/2017
• Supplement Date Received by Manufacturer: 05/09/2017
• Initial Report FDA Received Date: 06/07/2017
• Supplement Report FDA Received Date: 06/30/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1