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	Break (1069)
Health Effect - Clinical Code	Radiation Exposure, Unintended (3164)
Date of Event	07/22/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Analysis found that the distal tip 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 that broke off measured approximately 0.24¿ in length.The outer assemblies were deformed in such a way that indicates the inner blade teeth impacted the outer teeth at the 1st proximal tooth while moving in a ccw direction which resulted in the observed break.There were no signs of misuse or mishandling however there was some gouging on the inner shaft outside diameter 0.56¿ from the distal face of the inner hub proceeding to 1.05¿ from the 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.
Event or Problem Description
A health care provider (hcp) reported via manufacturer representative that during a bilateral reduction of gynaecomastia using liposuction and handpiece.The handpiece was used to remove the glandular breast tissue.During the procedure the blade broke off and had to be retrieved with x-ray and extra incision was made to retrieve the broken part.The procedure was delayed for forty five minutes.The procedure was completed with backup product.

• 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: 8901268
• Report Number: 3004209178-2019-15777
• Device Sequence Number: 2048820
• Product Code: EQJ
• UDI-Device Identifier: 20681490047450
• UDI-Public: 20681490047450
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/16/2019

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 Expiration Date: 10/26/2025
• Device Model Number: 1884004
• Device Catalogue Number: 1884004
• Device Lot Number: HG23GEG
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/29/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/23/2019
• Initial Report FDA Received Date: 08/16/2019
• 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: 15 YR