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

Model Number 1883672HS

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/28/2016

Event Type  malfunction  

Manufacturer Narrative

The burs were discarded by the customer.Therefore, a product analysis will not be performed.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 Description

It was reported that intraoperative, the bur started to feel loose after approximately 30-45 minutes of drilling.This happened with three burs within the same case.In each instance, the surgeon stopped drilling and the device was removed from the patient.Outside of the patient, the burs were visually inspected.They noticed the burs were starting to come apart.After touching the tip during the visual inspection, the tip fell off.This took place away from the patient.Each time the surgeon was able to remove and replace the bur to complete the surgery.There was no patient injury.

Manufacturer Narrative

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

• Brand Name: XPS® BUR
• Type of Device: BUR, EAR, NOSE AND THROAT
• Manufacturer (Section D): MDT PUERTO RICO OPERATIONS CO; rd 31 km 24 hm 4; juncos PR 00777
• Manufacturer (Section G): MDT PUERTO RICO OPERATIONS CO; rd 31 km 24 hm 4; juncos PR 00777
• Manufacturer Contact: uriza shums ; 6743 southpoint drive north; jacksonville, FL 32216 ; 9043328405
• MDR Report Key: 6196915
• MDR Text Key: 63068194
• Report Number: 3004209178-2016-27023
• Device Sequence Number: 1
• Product Code: EQJ
• UDI-Device Identifier: 20721902100561
• UDI-Public: 20721902100561
• Combination Product (y/n): N
• Reporter Country Code: NO
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 11/29/2016

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: 05/26/2019
• Device Model Number: 1883672HS
• Device Catalogue Number: 1883672HS
• Device Lot Number: H7866345
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/29/2016
• Initial Date FDA Received: 12/21/2016
• Supplement Dates Manufacturer Received: 11/29/2016
• Supplement Dates FDA Received: 09/28/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/26/2011
• 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