MAUDE Adverse Event Report: SYMMETRY SURGICAL BEYER RONGEUR

Model Number 31-1104

Device Problem Insufficient Information (3190)

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

Event Date 03/16/2015

Event Type  malfunction  

Event Description

A screw from a beyer rongeur fell off the device during a tibia knee replacement surgery and remains in the pt.Post op x-ray was taken to locate the screw, screw is present inside the body in the cement.Pt has a nickel allergy.

• Brand Name: BEYER RONGEUR
• Type of Device: RONGEUR
• Manufacturer (Section D): SYMMETRY SURGICAL; 3034 owen dr; antioch TN 37013
• Manufacturer Contact: chris smith ; 3034 owen dr; antioch, TN 37013 ; 8002513000
• MDR Report Key: 4845320
• MDR Text Key: 5939810
• Report Number: 3007208013-2015-00012
• Device Sequence Number: 1
• Product Code: HTX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 06/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 31-1104
• Device Catalogue Number: 31-1104
• Other Device ID Number: 00887482068878
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/16/2015
• Event Location: Hospital
• Date Manufacturer Received: 03/16/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1