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

Model Number 1884004

Device Problems Material Separation (1562); Vibration (1674)

Patient Problem Radiation Exposure, Unintended (3164)

Event Date 05/09/2019

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event 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.

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at the cutting tip which may indicate an interference fit between the inner and outer assemblies at the tip.(b)(4) are no longer applicable.If information is provided in the future, a supplemental report will be issued.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
• Type of Device: 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
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: christy cain ; 6743 southpoint drive north; jacksonville, FL 32216 ; 9043328353
• MDR Report Key: 8664475
• MDR Text Key: 146858662
• Report Number: 3004209178-2019-10759
• Device Sequence Number: 1
• Product Code: EQJ
• UDI-Device Identifier: 00681490047456
• UDI-Public: 00681490047456
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/09/2019
• Initial Date FDA Received: 06/03/2019
• Supplement Dates Manufacturer Received: 07/05/2019
• Supplement Dates FDA Received: 07/25/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/17/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR
• Patient Weight: 72