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

Model Number 1885078HSE

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/04/2015

Event Type  malfunction  

Manufacturer Narrative

Blank fields in this report are the result of information not provided by the initial reporter or user facility.This device is used for therapeutic purposes.(b)(4).The device has not been received for evaluation.

Event Description

It was reported that the bur broke.There was no report of patient impact or injury as a result of this event.Additional information was received: the break was a shaft break with no fragments.Photographic images showed the device remained intact.

Manufacturer Narrative

The device was received for evaluation.Condition upon receipt: un-sealed sample, part number 1885078hse, from lot number 0207851669 received.Equipment used: microscope (zeiss stemi 2000c between 0, 65 to 5, 0 magnification settings), calipers.Evaluation: when compared to the assembly drawing, visually, the inner assembly was stretched out of its support area by approximately 0.22¿ which would have resulted in the reported event.The inner assembly spins however it is with resistance, which is likely caused by the stretching (deformation) of the spiral wrap.There was no portion of the device that became detached.When viewed under magnification, there was no additional evidence to isolate a cause therefore manufacturing, supplier, and misuse / mishandling cannot be ruled out as potential causes.Methods - actual device evaluated.(b)(4).

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 INC.; 6743 southpoint dr n; jacksonville FL 32216
• Manufacturer Contact: charlotte ayala ; 6743 southpoint dr n; jacksonville, FL 32216 ; 9042797584
• MDR Report Key: 5257497
• MDR Text Key: 32504412
• Report Number: 1045254-2015-00397
• Device Sequence Number: 1
• Product Code: EQJ
• Combination Product (y/n): N
• Reporter Country Code: TH
• 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: 11/05/2015

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
• Device Operator: Health Professional
• Device Expiration Date: 12/18/2017
• Device Model Number: 1885078HSE
• Device Catalogue Number: 1885078HSE
• Device Lot Number: 0207851669
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/05/2015
• Initial Date FDA Received: 12/01/2015
• Supplement Dates Manufacturer Received: Not provided; 12/03/2015
• Supplement Dates FDA Received: 12/28/2015; 09/19/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/19/2013
• 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