MAUDE Adverse Event Report: MEDTRONIC XOMED INC. XPS® BUR - HIGH SPEED RAD®; BUR, EAR, NOSE AND THROAT

Model Number 1883670HS

Device Problem Break (1069)

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

Event Date 11/23/2015

Event Type  malfunction  

Manufacturer Narrative

This device is used for therapeutic purposes.(b)(4).The device was returned for evaluation.Condition upon receipt: 1 un-sealed sample, part number 1883670hs, from lot number 62671600 received; there was evidence of biological contaminants [based off of the reactivity with hydrogen peroxide].Equipment used: microscope (zeiss stemi 2000c between 0, 65 to 5, 0 magnification settings), m4 handpiece (part 1898200t), calipers.Evaluation: when compared to the assembly drawing and inner assembly drawing of the distal portion of the inner assembly became detached which would have resulted in the reported event.The break point corresponds to the proximal side of the outer tube radius.Included with the returned device were 2 spiral wrap fragments measuring less than 1/8¿ each.When viewed under magnification, the spiral wrap was coiled in on itself in a clockwise direction which likely indicates the break occurred while being used in forward direction.There was gouging in the support area just proximal to the distal tip (both the inside and outside diameters) which indicates excess pressure was being applied during use.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; and damage to the inner hub chevrons caused by the handpiece drive mechanism.The instructions for use has detailed instructions for properly loading a bur/blade into the handpiece and warn that excessive pressure applied to a bur/blade may cause a fracture.Note: [excess: exceeded sufficient pressure required for operation].Functionally, the bur loaded securely into a handpiece.There was no evidence of improper manufacturing and therefore has been ruled out as a likely cause.

Event Description

It was reported that the bur broke.There was no patient injury reported.

• Brand Name: XPS® BUR - HIGH SPEED RAD®
• 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 drive north; jacksonville FL 32216
• Manufacturer Contact: charlotte ayala ; 6743 southpoint drive north; jacksonville, FL 32216 ; 9043328372
• MDR Report Key: 5311669
• MDR Text Key: 34611898
• Report Number: 1045254-2015-00432
• Device Sequence Number: 1
• Product Code: EQJ
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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
• Report Date: 11/26/2015

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: 06/26/2017
• Device Model Number: 1883670HS
• Device Catalogue Number: 1883670HS
• Device Lot Number: 62671600
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/26/2015
• Initial Date FDA Received: 12/18/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/16/2009
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1