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

Model Number	1884008
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/12/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned.A product analysis has not been performed.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 customer reported that during a tonsillectomy and adenoidectomy, the blade was not sharp enough, did not cut the tissue, and broke at the spiral wrap.There was a delay to the case.A replacement bur was used to complete the case.The break did not result in fragments that required retrieval from the patient.There was no patient impact.
Additional Manufacturer Narrative
The product analysis indicates that one opened sample of part number 1884008 from lot number hg0khhu was received.There was a residue consistent with biological contaminants on the device.A microscope was used to evaluate the device.Visually, there was no damage or anomalies of the cutting tip that would have resulted in reduced performance.A portion of the inner assembly was pulled out and found to be broken at the proximal end of the spiral wrap.The break would have been contained by the outer assembly and the handpiece therefore would not result in device fragments.The spiral wrap was twisted in on itself which likely indicated the device was being ran in forward direction instead of oscillating.The maximum recommended speed for this device is 1,500 rpm in oscillate mode / direction.The remainder if the distal end of the inner assembly spun freely within the outer assembly.There was a residue consistent with tape adhesive at the tip, however it is unlikely to have contributed to this event.There was no allegation of a defect prior to use.There was no evidence of improper manufacturing and therefore has been ruled out as a likely cause.The information most likely indicates the blade was being use beyond the recommended speed or improper direction.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: 6851413
• Report Number: 3004209178-2017-18963
• Device Sequence Number: 1600848
• Product Code: EQJ
• UDI-Device Identifier: 20681490047481
• UDI-Public: 20681490047481
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/17/2017

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: 06/05/2023
• Device Model Number: 1884008
• Device Catalogue Number: 1884008
• Device Lot Number: HG0KHHU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/14/2017
• Supplement Date Received by Manufacturer: 10/23/2017
• Initial Report FDA Received Date: 09/08/2017
• Supplement Report FDA Received Date: 11/17/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 12 YR