MAUDE Adverse Event Report: SYMMETRY SURGICAL INC. SYMMETRY RHOTON MICRO CUP FORCEPS

Model Number 53-4008

Device Problem Insufficient Information (3190)

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

Event Date 10/09/2014

Event Type  malfunction  

Event Description

Micro pituitary broke intra-operatively while doctor was using it on a cervical disc.The item was removed from the sterile filed and given to materials coordinator.The wound was checked with microscope, all pieces accounted for.X-ray done and read by radiology.X-ray negative for instruments or from broken pituitary.Doctor aware of the x-ray results.No harm to the pt.Original intended procedure: c5-6, c6-7 anterior cervical diskectomies, allograft fusions and the anterior cervical plating using a medtronic venture plate.Device failed (e.G.Broke, couldn't get it to work or stopped working).

• Brand Name: SYMMETRY RHOTON MICRO CUP FORCEPS
• Type of Device: MICRO CUP FORCEPS
• Manufacturer (Section D): SYMMETRY SURGICAL INC.; 3034 owen dr; antioch TN 37013
• Manufacturer Contact: chris smith ; 3034 owen dr; antioch, TN 37013 ; 8002513000
• MDR Report Key: 4828289
• MDR Text Key: 5903058
• Report Number: 3007208013-2015-00007
• Device Sequence Number: 1
• Product Code: GZX
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/01/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 53-4008
• Device Catalogue Number: 53-4008
• Other Device ID Number: 00887482023495
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/19/2015
• Distributor Facility Aware Date: 03/19/2015
• Event Location: Hospital
• Date Report to Manufacturer: 04/28/2015
• Date Manufacturer Received: 04/28/2015
• 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
• Patient Age: 36 YR
• Patient Weight: 52