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

Model Number	1882940
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/28/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The blade has been received.Product analysis results are pending completion of the evaluation.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The customer reported that preoperative, the blade tip broke off.The break did not result in a fragment that required retrieval from the patient.
Additional Manufacturer Narrative
The product analysis indicates that one opened sample of (b)(4) from lot number hg1mc9q was received.A microscope and calipers were used to evaluate the device.Visually, the tip of the inner shaft broke off, which would have resulted in the reported event.The portion that became detached measured 0.176¿ in length.When viewed under magnification there was an impact mark on the outer cutting surface and the configuration of the impact was consistent with the inner assembly moving in a clockwise direction when the impact occurred.The manufacturing instructions include a requirement to rotate the hub cutter assembly to verify that there is no resistance or unusual grinding noises and there are damage checks throughout the process.When viewed under magnification, there was damage to the hubs that is consistent with improper loading: dimples on the front hub prior to the locking area caused by the handpiece locking mechanism; locking area damage caused by the back side of the front collet of the handpiece; and damage to the inner hub chevrons caused by the handpiece drive mechanism.The ifu has detailed instructions for properly loading a bur/blade into the handpiece.Even with the deformation of the hubs, functionally, the blade loaded securely into a handpiece.Improperly loading a blade into a handpiece would result in instability between the inner and outer assemblies and may also cause axial pressure to transfer to the tip where the break occurred.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: 6887244
• Report Number: 3004209178-2017-19914
• Device Sequence Number: 13612253
• Product Code: EQJ
• UDI-Device Identifier: 20681490863364
• UDI-Public: 20681490863364
• 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): 10/27/2017

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: 01/26/2025
• Device Model Number: 1882940
• Device Catalogue Number: 1882940
• Device Lot Number: HG1MC9Q
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/19/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/28/2017
• Supplement Date Received by Manufacturer: 10/04/2017
• Initial Report FDA Received Date: 09/22/2017
• Supplement Report FDA Received Date: 10/27/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1