MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. XPS® BLADE; BUR, EAR, NOSE AND THROAT

Model Number	1884012HR
Medical Device Problem Code	Stretched (1601)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/20/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The blade was received for analysis.Visually, the inner shaft was bent and a section of the inner spiral was included in a small bag which would have resulted in the reported event.The bend in the inner shaft was next to the distal face of the inner hub; the severity of the bend indicates that the device could not have been used if the defect were present prior to use; and therefore, it is likely the damage occurred during unloading of the blade from the handpiece or sometime after.The section of spiral wrap that was included in the bag measured approximately 0.24¿ long.Initially it could not be determined how the portion of the spiral wrap became detached because it should have been contained by the outer assembly; further analysis found that the outer cutter tip was not attached and slid off the end which would have exposed the spiral wrap.The detached portion of the tip measured approximately 0.44¿ long.When viewed under magnification there was damage to the teeth that is consistent with impact.There was no allegation of a defect prior to use.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The physician reported that while using the rad 12 blade the inner cylinder of the device was broken.It was confirmed that after st retching, a fragment of the spiral wrap detached; however, it did not fall into the patient or require retrieval.A back-up blade was used to complete the procedure.There was no patient impact.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: XPS® BLADE
• 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: 6866822
• Report Number: 3004209178-2017-19377
• Device Sequence Number: 699889
• Product Code: EQJ
• UDI-Device Identifier: 20885074080608
• UDI-Public: 20885074080608
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 08/21/2017

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: 01/19/2021
• Device Model Number: 1884012HR
• Device Catalogue Number: 1884012HR
• Device Lot Number: HG1LU5A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/25/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/21/2017
• Supplement Date Received by Manufacturer: 09/18/2017
• Initial Report FDA Received Date: 09/14/2017
• Supplement Report FDA Received Date: 09/21/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1