MAUDE Adverse Event Report: SYMMETRY SURGICAL INC. SYMMETRY KERRISON; MICRO RONGEUR, THIN FOOTPLATE

Model Number 57-0761

Device Problem Missing Value Reason (3192)

Patient Problem No Code Available (3191)

Event Date 11/11/2015

Event Type  No Answer Provided  

Manufacturer Narrative

Device was returned to symmetry for evaluation.No credit or replacement to the customer.Device will not be replaced for the customer.A follow-up has already been sent to the customer.This damage has been determined to be due to excessive force applied while biting hard bone.This is a thin footplate that should be used to only cut through the soft bone surrounding the cortical bone.Symmetry has only received one complaint of this nature.No items in inventory to review for containment actions (11/11/2015).

Event Description

Part of a distal tip broke off, no harm was done to the patient, they didn't report anything on their end.

• Brand Name: SYMMETRY KERRISON
• Type of Device: MICRO RONGEUR, THIN FOOTPLATE
• Manufacturer (Section D): SYMMETRY SURGICAL INC.; 3034 owen dr; antioch TN 37013
• Manufacturer (Section G): SYMMETRY SURGICAL INC.; 3034 owen dr; antioch TN 37013 0000
• Manufacturer Contact: victoria rogers ; 3034 owen dr; antioch, TN 37013 ; 8002513000
• MDR Report Key: 5276842
• MDR Text Key: 33780017
• Report Number: 3007208013-2015-00034
• Device Sequence Number: 1
• Product Code: HTX
• UDI-Device Identifier: 00887482093177
• UDI-Public: 00887482093177
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/25/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 57-0761
• Device Catalogue Number: 57-0761
• Device Lot Number: 119531
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 11/19/2015
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 11/11/2015
• Device Age: 3 YR
• Event Location: Hospital
• Date Manufacturer Received: 11/12/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2012
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1