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

Model Number 1885076HSE

Device Problems Break (1069); Use of Device Problem (1670)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 07/02/2018

Event Type  malfunction  

Manufacturer Narrative

Evaluation was performed as the device has not been returned at this time.If information is provided in the future, a supplemental report will be issued.

Event Description

A healthcare professional reported via a manufacturer representative that the bur wasn't working well and the tool broke at the end when trying to detach it from the microdebrider.The tool was replaced and the microdebrider was changed.It was noted that patient symptoms were unknown and there was no injury.

Manufacturer Narrative

Analysis of the returned device indicated that the inner assembly would spin freely by hand.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 deformation caused by the back side of the front collet of the handpiece; and deformation of the inner hub chevrons caused by the handpiece drive mechanism.There were no loose components.Even with the deformation of the hubs, functionally, the bur loaded securely into a handpiece, ran at 12,000 rpm in forward mode, and cut saw bone with no issues.There was no breakage of the bur.There was an out of specification condition identified as it relates to the complaint (due to physical damage).If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: XPS® BLADE
• Type of Device: BUR, EAR, NOSE AND THROAT
• Manufacturer (Section D): MEDTRONIC XOMED INC.; 6743 southpoint dr n; jacksonville FL 32216
• Manufacturer (Section G): MEDTRONIC XOMED INC.; 6743 southpoint dr n; jacksonville FL 32216
• Manufacturer Contact: uriza shums ; 6743 southpoint dr. n.; jacksonville, FL 32216 ; 9043328405
• MDR Report Key: 7728422
• MDR Text Key: 115468155
• Report Number: 1045254-2018-00326
• Device Sequence Number: 1
• Product Code: EQJ
• UDI-Device Identifier: 00613994233196
• UDI-Public: 00613994233196
• Combination Product (y/n): N
• Reporter Country Code: SN
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 10/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2021
• Device Model Number: 1885076HSE
• Device Catalogue Number: 1885076HSE
• Device Lot Number: 0213957673
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/08/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 39 YR