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

Model Number 31180698E

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/30/2015

Event Type  malfunction  

Manufacturer Narrative

This device is used for therapeutic purposes.Concomitant medical products: bur 31180698e visao cvd diamd.6x98mm l, 510k: exempt , lot# 0209568969, mfr date:2015-05-06, use before: 2019-05-05.(b)(4).The products have not been returned for analysis.

Event Description

It was reported that the tip of the bur broke off and was lodged in patient during cochlear implant.It was removed via suction, without complications.The patient was fine when woken from procedure.

Manufacturer Narrative

Devices received on (b)(4) 2015.Devices evaluated on (b)(4) 2015.During product analysis, the devices were compared to the assembly drawing.When lot # 0209674535 was viewed under magnification, the distal tip was missing and not returned.The shaft broke just inside the outer tube meaning the piece that broke off measured approximately (0.12¿).The fracture was cone shaped which suggests a compression fracture however this cannot be confirmed.Under magnification there was no additional evidence to isolate a cause regarding lot # 0209568969, the tip was present and measured 0.64mm which is not consistent with the reported event.The inner assembly had 0.15¿ axial play which exceeds the allowed tip tolerance of +-0.015¿.The overall length is a reference dimension on the drawing (3.814¿) which carries no tolerance requirement; the overall length was measured at approximately 3.82¿ which is within a reasonable range.Functionally the bur would load into a handpiece, run at 80,000 rpm, and cut saw bone with no issues.The excess axial play may have been the result of extended use and wear or may have been an out of specification condition from manufacturing.(b)(4).

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): 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: amy corrales ; 6743 southpoint dr. n.; jacksonville, FL 32216 ; 9043328138
• MDR Report Key: 5266693
• MDR Text Key: 32926077
• Report Number: 1045254-2015-00403
• Device Sequence Number: 1
• Product Code: EQJ
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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,Followup
• Report Date: 11/11/2015

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: 06/02/2019
• Device Model Number: 31180698E
• Device Catalogue Number: 31180698E
• Device Lot Number: 0209674535
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/11/2015
• Initial Date FDA Received: 12/04/2015
• Supplement Dates Manufacturer Received: Not provided; 12/17/2015
• Supplement Dates FDA Received: 12/21/2015; 09/19/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/03/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1