MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. TRICUT® STRAIGHT SHAFT 4MM 11CM LONG; BUR, EAR, NOSE AND THROAT

Model Number	1884004
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/29/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
A healthcare provider (hcp) reported that after the blade was used for 30 minutes for functional endoscopic sinus surgery (fess), the tip of this blade got broken.A fragment of the tip dropped.The doctor removed the fragment from the operation area and checked thoroughly to make sure no other fragment was remained in the operation area.It was the initial use of the blade.Then, the doctor changed to another new blade to complete the surgery.The second device could function properly with the same hand piece and power system.The event resulted to 5-10 minutes of delay.There was no patient impact.
Additional Manufacturer Narrative
Analysis found that the distal tip had broken off the inner cutter.The break occurred at the first proximal tooth valley.The distal tip outside diameter of the inner cutter (expanded area) appear to have a turned / machined finish.The assemblies were deformed in such a way that indicates the inner blade teeth impacted the outer cutting edge at the 4th proximal tooth while moving in a ccw direction which resulted in the break.There were no signs of bends, concentricity, misuse, or mishandling.There was uneven wear at the cutting tip which may indicate an interference fit between the inner and outer assemblies at the tip.There was some minor wear on the inner shaft from the distal face of the inner hub.Deformation of the outer tube distal tip has been proven to cause the inner blade tip to fracture at the first proximal tooth valley.If information is provided in the future, a supplemental report will be issued.

• Brand Name: TRICUT® STRAIGHT SHAFT 4MM 11CM LONG
• Common Device Name: BUR, EAR, NOSE AND THROAT
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• MDR Report Key: 9117126
• Report Number: 3004209178-2019-18356
• Device Sequence Number: 11384485
• Product Code: EQJ
• UDI-Device Identifier: 00681490047456
• UDI-Public: 00681490047456
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/05/2019

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: 1884004
• Device Catalogue Number: 1884004
• Device Lot Number: HG2WGPR
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/06/2019
• Supplement Date Received by Manufacturer: 11/11/2019
• Initial Report FDA Received Date: 09/25/2019
• Supplement Report FDA Received Date: 12/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 42 YR