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

Model Number 1884068HS

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/03/2014

Event Type  malfunction  

Manufacturer Narrative

The device was returned on (b)(4) 2015.Analysis was completed on (b)(4) 2015.The product analysis found that for all three devices (2 samples of 1884560hs and 1 sample of 1884068hs), there was evidence of biologicals from visual inspection and reactivity with hydrogen peroxide.The hub and a portion of the inner shaft were separate from the rest of the devices.The inner shaft was broken 0.62" from the distal face of the inner hub which would have resulted in the reported malfunction.The break point corresponds to the proximal end of the outer tube in the front hub.When viewed under magnification, there were striations at the break point indicating metal on metal contact and an uneven break.The information indicates excess pressure was applied during use which caused deformation of the locking area, which then caused the inner shaft and outer tube to rub together until the inner shaft broke.

Event Description

It was reported that during surgery, 3 high-speed burs broke at the bottom of the shaft where the blade connects to the hub.There was no harm to the patient.The reporter was unable to confirm if the break resulted in any fragments in the surgical field.

Manufacturer Narrative

This device is used for therapeutic purposes.Concomitant device: bur 1884560hs; 510k: exempt; lot# 020680560 ; manufactured date: 2013-03-23 ; use-by date: 2021-03-21.(b)(4).The product has not been returned for analysis.Method: no testing methods performed.(b)(4).

Manufacturer Narrative

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

• Brand Name: XPS® MICRODEBRIDER 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): MEDTRONIC XOMED, INC; 6743 southpoint drive north; jacksonville FL 32216
• Manufacturer Contact: amy corrales ; 6743 southpoint drive north; jacksonville, FL 32216 ; 9043328138
• MDR Report Key: 4366583
• MDR Text Key: 12798298
• Report Number: 3004209178-2014-24605
• Device Sequence Number: 1
• Product Code: EQJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative,company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 12/04/2014

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: 10/16/2020
• Device Model Number: 1884068HS
• Device Catalogue Number: 1884068HS
• Device Lot Number: H8457196
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/29/2015
• Initial Date FDA Received: 12/29/2014
• Supplement Dates Manufacturer Received: Not provided; 01/29/2015
• Supplement Dates FDA Received: 02/02/2015; 09/15/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/16/2012
• 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: 00020 YR