MAUDE Adverse Event Report: MEDTRONIC XOMED INC. XPS® SYSTEM NAVIGATED BLADE; BUR, EAR, NOSE AND THROAT

Model Number	1884012EM
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/07/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been returned, however the analysis results are pending completion of the evaluation.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 sales rep reported that intraoperative, the rad 12 blade tip broke off while site was cleaning it over the back table.They were able to complete the surgery with other instruments.There was no patient impact.
Additional Manufacturer Narrative
The product analysis indicates that one opened sample of part number 1884012em from lot number 0213089023 was received.There was a residue consistent with biological contaminants on the device.A microscope and calipers were used to evaluate the device.Visually, the tip of the middle assembly had become detached at the distal end of the spiral wrap which would have resulted in the reported event.The portion that became detached measured 0.45¿ in length.When viewed under magnification, there was damage to the hub that is consistent with improper loading: dimples on the front hub prior to the locking area caused by the handpiece locking mechanism; and locking area damage caused by the back side of the front collet of the handpiece.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 component assemblies.The customer indicated the breakage occurred while cleaning which may have also contributed to the observed damage.The ifu warns that insertion of metal objects in accessory tip may cause the accessory to break; and bending or prying may break the accessory.There was no allegation of a defect prior to use.If information is provided in the future, a supplemental report will be issued.

• Brand Name: XPS® SYSTEM NAVIGATED BLADE
• Common Device Name: BUR, EAR, NOSE AND THROAT
• Manufacturer (Section D): MEDTRONIC XOMED INC.; 6743 southpoint dr n; jacksonville FL 32216
• MDR Report Key: 6907753
• Report Number: 1045254-2017-00340
• Device Sequence Number: 683394
• Product Code: HAW
• UDI-Device Identifier: 00613994617415
• UDI-Public: 00613994617415
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: K050438
• 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): 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: 03/26/2019
• Device Model Number: 1884012EM
• Device Catalogue Number: 1884012EM
• Device Lot Number: 0213089023
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/07/2017
• Supplement Date Received by Manufacturer: 10/04/2017
• Initial Report FDA Received Date: 10/02/2017
• 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
• Patient Age: 42 YR
• Patient Weight: 84