MAUDE Adverse Event Report: SYMMETRY SURGICAL INC SYMMETRY LOVE-GRUENWALD; SPURLING IVD RONGEUR

Catalog Number 53-1240

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 09/17/2018

Event Type  malfunction  

Manufacturer Narrative

The outcome of the patient, lot number, and age of the instrument are unknown.Multiple attempts have been made for additional information.We will continue to try for additional information.A follow-up report will be submitted once we gain additional information.There has been a total of (b)(4) sold since 2012 with no additional complaints recorded.

Event Description

On (b)(6) 2018 during an unknown procedure, a disc rongeur broke its gripper inside the patient.X-rays were performed many times in order to monitor the event.There were seven unsuccessful attempts performed using a microscope to remove the broken fragment/s.It is unknown how the procedure was completed.

• Brand Name: SYMMETRY LOVE-GRUENWALD
• Type of Device: SPURLING IVD RONGEUR
• Manufacturer (Section D): SYMMETRY SURGICAL INC; 3034 owen drive; antioch TN 37013
• Manufacturer (Section G): SYMMETRY SURGICIAL INC; 3034 owen drive; antioch TN 37013
• Manufacturer Contact: brandi meath ; 3034 owen drive; antioch, TN 37013 ; 6159645290
• MDR Report Key: 8769377
• MDR Text Key: 150443083
• Report Number: 3007208013-2019-00026
• Device Sequence Number: 1
• Product Code: HAE
• UDI-Device Identifier: 00887482022191
• UDI-Public: 00887482022191
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 53-1240
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/11/2019
• 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: Reuse
• Patient Sequence Number: 1