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 Codes	Material Separation (1562); Vibration (1674)
Health Effect - Clinical Code	Radiation Exposure, Unintended (3164)
Date of Event	05/09/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
A manufacturer representative present during the case reported that the surgeon was performing an endoscopic surgery to remove polyps when the blade started to shake and realized that the inner blade broke off.Another blade from the same batch was used and the exact same thing occurred.One of the inner blades was missing but intraoperative x-ray confirmation validated that it was not inside the patient.It was noted that the other tip was found.The procedure was performed with the third blade available from the same batch which worked correctly.There was a 50-minute delay in the procedure.The patient was alive with no injury.
Additional Manufacturer Narrative
Analysis found that visually, the distal tips of the inner cutter broke off which would have resulted in the reported event.The breakage occurred at the first proximal tooth valley.The portion of the tip that was returned, measured approximately 0.24¿ in length (the other tip not returned would have measured approximately the same length.The outer assemblies were deformed in such a way that indicates the inner blade teeth impacted the outer teeth at the 2nd proximal valley while moving in a ccw direction which resulted in the observed breaks.It could not be determined if the expanded tip outside diameters had been machined / turned.There were no signs of bends or concentricity issues.There were no signs of misuse or mishandling however there was some gouging on the inner shafts outside diameter 0.56¿ from the distal face of the inner hubs.There was uneven wear at the cutting tip which may indicate an interference fit between the inner and outer assemblies at the tip.(b)(4) are no longer applicable.If information is provided in the future, a supplemental report will be issued.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: 8664475
• Report Number: 3004209178-2019-10759
• Device Sequence Number: 16662925
• Product Code: EQJ
• UDI-Device Identifier: 00681490047456
• UDI-Public: 00681490047456
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 1884004
• Device Catalogue Number: 1884004
• Device Lot Number: HG2P0GF
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/03/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/09/2019
• Supplement Date Received by Manufacturer: 07/05/2019
• Initial Report FDA Received Date: 06/03/2019
• Supplement Report FDA Received Date: 07/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 68 YR
• Patient Weight: 72