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

Model Number 5407-FA2-000

Device Problems Charred (1086); Overheating of Device (1437); Device Operates Differently Than Expected (2913)

Patient Problem No Information (3190)

Event Date 04/24/2017

Event Type  malfunction  

Event Description

Bearings failed, causing drill bit to run on surface of guard, therefore leading to heat and charring.

• Brand Name: FOOTED ATTACHMENT
• Type of Device: DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)
• Manufacturer (Section D): STRYKER INSTRUMENTS; 4100 east milham ave.; kalamazoo MI 49001
• MDR Report Key: 6571945
• MDR Text Key: 75332325
• Report Number: 6571945
• Device Sequence Number: 1
• Product Code: HBE
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 5407-FA2-000
• Device Catalogue Number: 5407-FA2-000
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/02/2017
• Event Location: Hospital
• Date Report to Manufacturer: 05/02/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 46 YR