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

Model Number	1884002
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation was not performed; product was not returned for analysis.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 blades broke at the tip twice last month.The fragments that resulted from the break in both cases were safely removed from the patient without needing x-ray.The patients on both cases did not have particularly hard bone.On both cases it was around the ethmoid cavity.One patient may have had polyps and other just chronic sinus sinusitis.Event dates for these two cases are unknown.Additional information received that a similar incident happened in a third case on (b)(6) 2017.Case 1 of 3 was filed under regulatory report # 3004209178-2017-20317 (medtronic internal reference number (b)(4)).This regulatory report is being filed for case 2 of 3 (medtronic internal reference number (b)(4)).A third regulatory report will be filed for case 3 of 3 that occurred on (b)(6) 2017.(medtronic internal reference number (b)(4)).
Additional Manufacturer Narrative
The product analysis indicates one opened sample of part number 1884002 from lot number hg1wdg1 was received.A microscope and calipers were used to evaluate the device.Visually, the inner tip was lifted out of the cutting mouth opening at the distal end which would have resulted in the reported event.No portions broke off.The mouth opening showed impact marks on the outer and inner cutters consistent with the damage occurring while the blade was moving in a counterclockwise direction.There were no signs of misuse or mishandling.There was uneven wear at the tip of the inner assembly outside diameter which may indicate an interference fit (profile deviation) between the inner and outer assemblies.The inner cutter and outer tube are supplier manufactured.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: 6903662
• Report Number: 3004209178-2017-20318
• Device Sequence Number: 16340514
• Product Code: EQJ
• UDI-Device Identifier: 20681490047443
• UDI-Public: 20681490047443
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/23/2018

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: 06/14/2025
• Device Model Number: 1884002
• Device Catalogue Number: 1884002
• Device Lot Number: HG1WDG1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/30/2017
• Supplement Date Received by Manufacturer: 01/31/2018
• Initial Report FDA Received Date: 09/29/2017
• Supplement Report FDA Received Date: 02/23/2018
• Patient Sequence Number: 1