MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK, INC OBTRUATOR SCREW DRIVER; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number 7484154

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

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

Event Date 11/27/2017

Event Type  malfunction  

Event Description

In an attempt to remove previous hardware, doctor used a medtronic t-25 obturator screw driver, but approximately 1/1.5mm of its tip broke off in the process.The broken off tip was removed from the patient and placed on the back table.

• Brand Name: OBTRUATOR SCREW DRIVER
• Type of Device: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK, INC; 1800 pyramid place; memphis TN 38132
• MDR Report Key: 7537279
• MDR Text Key: 109097646
• Report Number: 7537279
• 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: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/12/2017,04/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 7484154
• Device Catalogue Number: 7484154
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/12/2017
• Event Location: Hospital
• Date Report to Manufacturer: 12/12/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 70 YR