MAUDE Adverse Event Report: STRYKER INSTRUMENTS TAPERED ROUTER; DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)

Model Number 5407-FA2-023

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 03/31/2022

Event Type  malfunction  

Event Description

Tapered router bit broke during surgery.Fda safety report id# (b)(4).

• Brand Name: TAPERED ROUTER
• Type of Device: DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)
• Manufacturer (Section D): STRYKER INSTRUMENTS
• MDR Report Key: 14085016
• MDR Text Key: 289220085
• Report Number: MW5108913
• Device Sequence Number: 1
• Product Code: HBE
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 04/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 5407-FA2-023
• Device Lot Number: 22021017
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 51 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White