MAUDE Adverse Event Report: MEDTRONIC XOMED INC. 4 MM HIGH SPEED TAPERED DIAMOND BURR

Catalog Number 1883672HS

Device Problems Break (1069); Component Missing (2306)

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

Event Date 07/23/2015

Event Type  malfunction  

Event Description

Endonasal sinus surgery was in progress when the high speed tapered diamond, 4mm 70 degree, burr's tip (ref# (b)(4)/lot#0209598413) was noted to be missing.No patient/staff harm.Additional burrs obtained for procedure to continue.Two more endonasal drill attachments from the same manufacturer/company broke during the case: first, ref#(b)(4)/ lot#0209504794 - high speed round diamond burr, 5mm 15 degree, burr's 䓠neck broke and the tip popped out while in use.Second, ref#(b)(4)/ lot#0209237919 - high speed tapered diamond burr 4mm 70 degree, burr broke.

• Brand Name: 4 MM HIGH SPEED TAPERED DIAMOND BURR
• Type of Device: BURR
• Manufacturer (Section D): MEDTRONIC XOMED INC.; 6743 southpoint dr., north; jacksonville FL 32216
• MDR Report Key: 5034322
• MDR Text Key: 24213057
• Report Number: 5034322
• Device Sequence Number: 1
• Product Code: HTT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Report Date: 08/14/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Catalogue Number: 1883672HS
• Device Lot Number: 0209598413
• Other Device ID Number: 4MM 70 DEGREE
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/14/2015
• Event Location: Hospital
• Date Report to Manufacturer: 08/14/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/27/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 43 YR