MAUDE Adverse Event Report: BRASSELER U.S.A. MEDICAL, LLC; BURR, ORTHOPEDIC

Catalog Number 14-C0108

Device Problems Break (1069); Detachment of Device or Device Component (2907); Physical Resistance/Sticking (4012)

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

Event Date 09/23/2019

Event Type  malfunction  

Event Description

Burr broke while surgeon was using it.The surgeon was using it on a pedicle, and the bottom end of the burr broke off; it was a clean break and no pieces were in the patient.Then, the technician couldn't get the rest of the burr out of the piece of equipment that holds it; it stayed stuck in the drill.Operating room staff obtained a new drill and new burr, and then proceeded with the surgery after a short delay.There was no injury to the patient.

• Type of Device: BURR, ORTHOPEDIC
• Manufacturer (Section D): BRASSELER U.S.A. MEDICAL, LLC; 4837 mcgrath st; ventura CA 93003
• MDR Report Key: 9218310
• MDR Text Key: 163174793
• Report Number: 9218310
• Device Sequence Number: 1
• Product Code: HTT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 10/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 14-C0108
• Device Lot Number: NQ5QZ
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/02/2019
• Event Location: Hospital
• Date Report to Manufacturer: 10/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 5110 DA
• Patient Weight: 43