MAUDE Adverse Event Report: SYMMETRY SURGICAL RHOTON; NERVE HOOK

Model Number 80-1689

Device Problem Appropriate Term/Code Not Available (3191)

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

Event Date 08/04/2014

Event Type  No Answer Provided  

Event Description

During a surgery of the cervical spine called "frykrolm" she tick the longitudinal band to touch or mobilize an intervertebral disk sequester.A small piece 2mm of the tip got stuck in the band.The facility in (b)(6) reported to (b)(6): during a surgery of the cervical spine called "frykrolm" she tick the longitudinal band to touch or mobilize a intervertebral disk sequester.A small piece 2mm of the tip got stuck in the band.Remedial action taken by the healthcare facility relevant to the care of the patient: prof.(b)(6) informed the patient that from her medical point of view there is no risk and she didn't expect any complications.Device tip broke during surgery, device was not returned to symmetry surgical for evaluation.

• Brand Name: RHOTON
• Type of Device: NERVE HOOK
• Manufacturer (Section D): SYMMETRY SURGICAL; antioch TN 37013 000
• Manufacturer Contact: chris smith ; 3034 owen dr; antioch, TN 37013-0000
• MDR Report Key: 4218676
• MDR Text Key: 5002068
• Report Number: 3007208013-2014-00017
• Device Sequence Number: 1
• Product Code: GZT
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/23/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 80-1689
• Device Catalogue Number: 80-1689
• Other Device ID Number: 00887482031476
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/21/2014
• 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