MAUDE Adverse Event Report: CONMED / LINVATEC HALL POWER PRO PIN DRIVER

Model Number PRO5232

Device Problems Detachment Of Device Component (1104); Component Falling (1105); Smoking (1585)

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

Event Date 11/04/2016

Event Type  malfunction  

Event Description

While using the drill noticed smoking and then noticed the internal parts form the drill head were falling out.The drill was taken off the sterile field.The foot as examined and an xray was taken of the pt's foot, there were no fragments noted in the pt incision.

• Brand Name: HALL POWER PRO PIN DRIVER
• Type of Device: POWER PRO
• Manufacturer (Section D): CONMED / LINVATEC
• MDR Report Key: 6107019
• MDR Text Key: 60692507
• Report Number: 6107019
• Device Sequence Number: 1
• Product Code: HWE
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 11/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PRO5232
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/04/2016
• Distributor Facility Aware Date: 11/04/2016
• Event Location: Ambulatory Surgical Facility
• 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: 30 YR
• Patient Weight: 73