MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. TRICUT® STRAIGHT SHAFT 4MM 11CM LONG M4 ROTATABLE; BUR, EAR, NOSE AND THROAT

Model Number	1884004HR
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/07/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product analysis indicates one opened sample of part number 1884004hr from lot number hg1q8nb was received.There was a residue consistent with biological contaminants on the device.A microscope and calipers were used to evaluate the device.Visually, the distal tip had broken off the inner cutter, which would have resulted in the reported event.The portion that became detached measured approximately 0.23¿ in length.The break occurred at the first proximal tooth valley.The inner assembly was deformed in such a way that indicates the inner blade teeth impacted the outer teeth while moving in a cw direction which resulted in the observed break.There was no allegation of a defect prior to use.There were no signs of misuse or mishandling.There was no evidence of concentricity issues.There was uneven wear at the cutting tip which may indicate an interference fit between the inner and outer assemblies at the tip.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The customer reported that the shaver head (tip) snapped off during the procedure.A replacement shaver blade was used until the end of the surgical procedure.There was no impact or injury to patient or staff.

• Brand Name: TRICUT® STRAIGHT SHAFT 4MM 11CM LONG M4 ROTATABLE
• 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: 7308070
• Report Number: 3004209178-2018-04281
• Device Sequence Number: 13692451
• Product Code: EQJ
• UDI-Device Identifier: 20885074079534
• UDI-Public: 20885074079534
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 03/01/2018

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: 03/07/2021
• Device Model Number: 1884004HR
• Device Catalogue Number: 1884004HR
• Device Lot Number: HG1Q8NB
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/07/2018
• Initial Report FDA Received Date: 03/01/2018
• Patient Sequence Number: 1
• Patient Age: 45 YR