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

Model Number	1883519HR
Medical Device Problem Codes	Vibration (1674); Connection Problem (2900)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/26/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
A health care provider (hcp) reported via a manufacturer representative that during a routine sinus surgery procedure, the inner portion of the blade has become loose and spins on its own without turning the blade.The procedure was completed with backup device.There was no patient impact or injury.
Additional Manufacturer Narrative
Corrected from medtronic xomed inc.To medtronic puerto rico operations co.Analysis found that the inner assembly would spin, and middle would index freely by hand with no unusual resistance.There was no damage to the tip.When viewed under magnification, there was damage to the hubs that is consistent with improper or difficulty loading the device into the handpiece: locking area deformation caused by the back side of the front collet of the handpiece; and deformation of the proximal inner hub chevrons caused by the handpiece drive mechanism.The user¿s guide has detailed instructions for properly loading a bur/blade into the handpiece.There were no loose components.Even with the deformation of the hubs, functionally the device loaded securely into a handpiece, ran at the maximum recommended speed of 3,000 rpm in oscillate mode/direction, and cut saw bone with no issues.There was no allegation of a defect prior to use.A review of the xpi did not indicate any evidence to point to improper manufacturing and there are checks for damage throughout the process.A bur or blade that is not properly loaded would result in improper support from the handpiece, engagement with the suction seal, drive, and locking mechanism.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 FL 00777
• MDR Report Key: 8730531
• Report Number: 1045254-2019-00308
• Device Sequence Number: 16583508
• Product Code: EQJ
• UDI-Device Identifier: 00885074080659
• UDI-Public: 00885074080659
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/24/2019

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 Model Number: 1883519HR
• Device Catalogue Number: 1883519HR
• Device Lot Number: HG2ZX73
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/30/2019
• Supplement Date Received by Manufacturer: 09/23/2019
• Initial Report FDA Received Date: 06/25/2019
• Supplement Report FDA Received Date: 09/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1