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

Model Number	1882040
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/14/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned for analysis.Device evaluation anticipated but not yet begun.
Event or Problem Description
The physician reported that the blade was broken during the surgery.No fragment was left in the patient's body.There was no delay of the surgery.There was no report of patient impact.
Additional Manufacturer Narrative
Device analysis was completed.One opened sample of part number 1882040, from lot number hg1dy3q was received.There was a residue consistent with biological contaminants on the device.Visually, the outer tube was bent at approximately 30 degrees and the inner shaft was broken 1.01¿ from the distal face of the inner hub which would have resulted in the reported event.The inner shaft break location corresponds to the bend in the outer tube when assembled.The break would have been contained by the outer tube and the handpiece.The conical shape of the break is consistent with ductile tension / stress.The information most likely indicates mishandling caused the bend in the outer tube and the stress was then transferred to the inner shaft which resulted in the break.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Additional information received from the customer indicated the blade did not break into pieces, it was bent.The doctor completed the surgery with traditional manual instruments.Note: manufacturer evaluation of the device indicated the device did break in the inner shaft.This break would be contained in the outer shaft and the handpeice; thus it would not be visible to the user.

• 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: 6931270
• Report Number: 3004209178-2017-21423
• Device Sequence Number: 16318491
• Product Code: EQJ
• UDI-Device Identifier: 20681490613280
• UDI-Public: 20681490613280
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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): 11/06/2017

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: 10/10/2024
• Device Model Number: 1882040
• Device Catalogue Number: 1882040
• Device Lot Number: HG1DY3Q
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/26/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/14/2017
• Supplement Date Received by Manufacturer: 10/24/2017
• Initial Report FDA Received Date: 10/09/2017
• Supplement Report FDA Received Date: 11/06/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1