MAUDE Adverse Event Report: BRASSELER USA 2.7MM TWIST DRILL STANDARD; DRILL BIT

Model Number 166-10-03

Device Problems Break (1069); Component Falling (1105)

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

Event Date 02/08/2018

Event Type  malfunction  

Event Description

Brasseler 2.7mm drill bit, twist drill standard, broke off in tibia during a right acl reconstruction.Broken portion of drill bit retrieved in its entirety.

• Brand Name: 2.7MM TWIST DRILL STANDARD
• Type of Device: DRILL BIT
• Manufacturer (Section D): BRASSELER USA; savannah GA 31419
• MDR Report Key: 7266547
• MDR Text Key: 100121314
• Report Number: MW5075201
• Device Sequence Number: 1
• Product Code: HTW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 166-10-03
• Device Catalogue Number: 166-10-03
• Device Lot Number: CE0123
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 21 YR