MAUDE Adverse Event Report: STERILMED, INC. SHAVER ENT TRICUT BLADE M4 ROTATABLE; DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE

Catalog Number	XOM18-84004HR
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/20/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not yet been returned for analysis.We are working on reviewing manufacturing record evaluation, once we get more information it will be submitted in a supplemental.Manufacturer's ref.No: (b)(4).
Event or Problem Description
It was reported that a patient underwent a level 4 endoscopy procedure with a shaver ent tricut blade m4 rotatable and the blade broke during surgery.The broken piece was retrieved.Another sterilmed device was used to complete procedure.There was no patient injury or consequence due to this event.The intent of the procedure was not altered because of this event.
Additional Manufacturer Narrative
Additional information was received on april 17, 2019 via user facility report# (b)(4).The following patient demographics were received: 32-year-old, male, 79 kg, not hispanic/latino, white.(b)(6).Manufacturer's ref.No: (b)(4).
Additional Manufacturer Narrative
The biosense webster inc.Product analysis lab received the device for evaluation on 5/9/2019.Therefore, populated d10.Device available for evaluation?, d10.Is device returned to manufacturer? and d10.Date device returned to manufacturer.Investigation summary: it was reported that a patient underwent a level 4 endoscopy procedure with a shaver ent tricut blade m4 rotatable and the blade broke during surgery.The broken piece was retrieved.Another sterilmed device was used to complete procedure.There was no patient injury or consequence due to this event.The intent of the procedure was not altered because of this event.A visual exam of the returned device finds considerable biological contaminants present and indications of use.It is also observed that the cutting edge teeth, of the distal tip of the device's inner part shaft, are bent outward and this distal cutting section is broken off from the remainder of the shaft.Based on the breakage and damage on the distal tip, and the scouring inside the distal tip of the outer shaft, this is indicative of excessive force on the device's structure, likely from contact made against other metal or another hard object during use and/or excessive torquing of the product during clinical use, causing the teeth of the inner shaft to catch on some undetermined object shaft as the device rotated.The distal portion of the inner part was still lodged up inside the shaft of the outer part.It was removed for further evaluation.There is significant damage and scouring of the surface just above the point where the shaft split apart.The split is jagged and the metal shows considerable fatigue.There is also observed damage to the cutting teeth of the outer part, further indicating the device came into contact with some other object or was undergoing excessive torquing.While this area appears bent and broken, no conclusion could be made as to what the device could have made contact with - another metal device or hard object.The instructions for use for reprocessed powered arthroscopic accessories (smi-420-235 rev.F), which provides various warnings and precautions, it is noted to state, "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.A manufacturing record evaluation was performed for the finished device lot# 2071798, and no discrepancies or internal actions were identified.Manufacturer's reference number: (b)(4).

• Brand Name: SHAVER ENT TRICUT BLADE M4 ROTATABLE
• Common Device Name: DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE
• Manufacturer (Section D): STERILMED, INC.; 5010 cheshire parkway; ste 2; plymouth MN 55446
• MDR Report Key: 8520933
• Report Number: 2134070-2019-00127
• Device Sequence Number: 19211316
• Product Code: ERL
• UDI-Device Identifier: 10888551025171
• UDI-Public: 10888551025171
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K081814
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/27/2019

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 Expiration Date: 01/21/2020
• Device Catalogue Number: XOM18-84004HR
• Device Lot Number: 2071798
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2019
• Initial Date Received by Manufacturer: 03/27/2019
• Supplement Date Received by Manufacturer: 04/17/2019; 05/09/2019
• Initial Report FDA Received Date: 04/16/2019
• Supplement Report FDA Received Date: 04/18/2019; 05/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Age: 32 YR
• Patient Weight: 79