MAUDE Adverse Event Report: GYRUS ACMI, INC. BURR, 4.2MM, 15DEG, FLUTTED BARREL

Model Number BUR4215FB

Device Problems Degraded (1153); Unintended Movement (3026)

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

Event Date 03/04/2015

Event Type  malfunction  

Event Description

It was reported that during a surgical procedure the connection between the drill and tubing set broke down, whereby the drill makes uncontrolled circular movements which causes dangerous situations in skull base surgery.

Manufacturer Narrative

The device was returned with a tube-set.Visually the burr appeared normal, the tubeset had one of its prongs torn off.During functional testing the shaft wobbled excessively and the burr was not rotating.The complaint was confirmed.It can be inferred that the friction between the stationary inner shaft and the rotating prongs caused the prong to tear off.This friction also caused handpiece to noticeably increase in temperature.Complaint history report reviewed and no trending was observed for this occurrence.Failure mode has not occurred frequently enough to require corrective action.Trending will continue to be monitored.

• Brand Name: BURR, 4.2MM, 15DEG, FLUTTED BARREL
• Type of Device: BURR
• Manufacturer (Section D): GYRUS ACMI, INC.; 2925 appling rd; bartlett TN 38133
• Manufacturer (Section G): GYRUS ACMI, INC.; 2925 appling rd; bartlett TN 38133
• Manufacturer Contact: angela caputo ; 136 turnpike rd; southborough, MA 01772 ; 5088042266
• MDR Report Key: 4694623
• MDR Text Key: 5646185
• Report Number: 1037007-2015-00003
• Device Sequence Number: 1
• Product Code: EQJ
• Combination Product (y/n): N
• Reporter Country Code: DA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/17/2015

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: Other
• Device Model Number: BUR4215FB
• Device Lot Number: JF892260
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/15/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Outcome(s): Required Intervention