MAUDE Adverse Event Report: SYMMETRY SURGICAL INC. SYMMETRY SHARP KERRISON RONGEUR, MANUAL

Catalog Number 53-1661

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/30/2018

Event Type  malfunction  

Event Description

During the acdf, the symmetry sharp kerrison tip broke off. The surgeon ordered an x-ray. The symmetry sharp kerrison tip could not be identified in the x-ray. The symmetry sharp kerrison could not be found in the surgical field. The patient to recovery in stable condition. No untoward effects.

• Brand Name: SYMMETRY SHARP KERRISON
• Type of Device: RONGEUR, MANUAL
• Manufacturer (Section D): SYMMETRY SURGICAL INC.; 3034 owen drive; antioch TN 37013
• MDR Report Key: 7726242
• MDR Text Key: 115231582
• Report Number: 7726242
• Device Sequence Number: 1
• Product Code: HAE
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 07/02/2018

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 07/27/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: 53-1661
• Was Device Available for Evaluation?: No Answer Provided
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/02/2018
• Event Location: Hospital
• Date Report to Manufacturer: 07/27/2018
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Is the Device Single Use?: No Answer Provided

Is This a Reprocessed and Reused Single-Use Device?

Type of Device Usage