MAUDE Adverse Event Report: MEDTRONIC XOMED INC HIGH SPEED TAPERED DIAMOND BUR

Catalog Number 1883672HS

Device Problems Break (1069); Component Falling (1105); Manufacturing, Packaging or Shipping Problem (2975); Material Integrity Problem (2978)

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

Event Date 12/28/2015

Event Type  malfunction  

Event Description

During endoscopic sinus surgery, the sinus drill was inserted into the patient´s right sinus and visible on the screen.Upon activating the foot pedal, the tip of drill #1 broke off in the patient´s sinus.The surgeon retrieved the broken piece and reported seeing no missing pieces left in the sinus.Inspection of the drill bit indicated coiled sheath that spirals around the inner piece seemed to have twisted off.An x-ray was performed to ensure there were no parts left in the patient´s sinus.Opened a second drill bit (#2).This piece showed the drill was about to break apart as well and it was removed from the field in one piece.Opened a third drill bit (#3).This drill would not fit into the drill handpiece.In addition, the hydrodebrider handpiece was manufactured wrong; it was missing a piece to be able fit into the machine/equipment.Additional supplies were used when the burr became loose (drill #4 and drill #5).

• Brand Name: HIGH SPEED TAPERED DIAMOND BUR
• Type of Device: HIGH SPEED TAPERED DIAMOND BUR
• Manufacturer (Section D): MEDTRONIC XOMED INC
• MDR Report Key: 5350092
• MDR Text Key: 35236730
• Report Number: 5350092
• Device Sequence Number: 1
• Product Code: EQJ
• 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
• Type of Report: Initial
• Report Date: 01/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 08/12/2023
• Device Catalogue Number: 1883672HS
• Device Lot Number: 0209998504
• Other Device ID Number: 4MM X 70 DEGREES
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/04/2016
• Event Location: Hospital
• Date Report to Manufacturer: 01/04/2016
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/07/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 61 YR