MAUDE Adverse Event Report: ACE SURGICAL SUPPLY COMPANY BUR TREPHINE35TL 2ID 2.8O

Model Number 04948001

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Code Available (3191)

Event Date 11/20/2019

Event Type  Injury  

Manufacturer Narrative

Trephine bur was abruptly stopped while motor continued to turn causing bur to shear into two pieces.

Event Description

Per assistant at the office, she said that they were performing an implant removal procedure when the product broke in half inside a patient's mouth.The patient was not injured and the piece was removed.

• Brand Name: BUR TREPHINE35TL 2ID 2.8O
• Type of Device: BUR TREPHINE
• Manufacturer (Section D): ACE SURGICAL SUPPLY COMPANY; 1034 pearl street; brockton MA 02301
• Manufacturer (Section G): ACE SURGICAL SUPPLY COMPANY; 1034 pearl street; brockton MA 02301
• Manufacturer Contact: doreen price ; 1034 pearl street; brockton, MA 02301 ; 8004413100
• MDR Report Key: 9743856
• MDR Text Key: 180531687
• Report Number: 1287163-2020-82419
• Device Sequence Number: 1
• Product Code: EJL
• UDI-Device Identifier: 00614950011797
• UDI-Public: 00614950011797
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 01/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 04948001
• Device Catalogue Number: 04948001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/17/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/17/2020
• 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