FDA Adverse Event Injury Summary report: N

BRASSELER DRILL BIT

MDR report key: 2994430 · Received February 28, 2013

Report

Report Number
MW5029259
Event Type
Injury
Date Received
February 28, 2013
Date of Event
September 28, 2012
Report Date
February 28, 2013
Manufacturer
BRASSELER
Product Code
HWE
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
NY, US
Reporter Occupation
RISK MANAGER

Narratives

Description of Event or Problem · 1

PT WITH HISTORY OF RHEUMATOID ARTHRITIS AND DEGENERATIVE JOINT DISEASE UNDERWENT A RIGHT TOTAL SHOULDER ARTHROPLASTY. THE TIP OF A 2.5 MM DRILL BIT BROKE OFF DURING THE PROCEDURE. IT WAS FLUOROSCOPICALLY IDENTIFIED AND IMMEDIATELY REMOVED.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
86693 BRASSELER DRILL BIT DRILL BIT HWE BRASSELER

Patients

Seq Age Sex Outcome Treatment
1 75 YR Required Intervention