MAUDE Adverse Event Report: SYMMETRY SURGICAL INC. CLASSIC PLUS(R) STERNAL NEEDLE HOLDER

Model Number 36-2025

Device Problems Insufficient Information (3190); Appropriate Term/Code Not Available (3191)

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

Event Date 08/03/2015

Event Type  No Answer Provided  

Manufacturer Narrative

Needle insert came apart and fell inside the patient.No harm to the patient.The needle holder inserts were inspected on devices from all lots in inventory.There were no issues with the inserts found.This device was manufactured in (b)(6) 2011.The inserts were repaired under warranty.The device is being repaired and returned to the customer under warranty.

Event Description

Needle insert came apart and fell inside the patient.No harm to patient.Device was manufactured in (b)(6) 2011.The inserts were repaired under warranty in (b)(6) 2013.

• Brand Name: CLASSIC PLUS(R) STERNAL NEEDLE HOLDER
• Type of Device: NEEDLE HOLDER
• Manufacturer (Section D): SYMMETRY SURGICAL INC.; 3034 owen dr; antioch TN 37013
• Manufacturer (Section G): SYMMETRY SURGICAL INC.; 3034 owen dr; antioch TN 37013
• Manufacturer Contact: victoria rogers ; 3034 owen dr; antioch, TN 37013 ; 8002513000
• MDR Report Key: 5100896
• MDR Text Key: 27588462
• Report Number: 3007208013-2015-00020
• Device Sequence Number: 1
• Product Code: HXK
• UDI-Device Identifier: 00887482009772
• UDI-Public: 00887482009772
• 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
• Remedial Action: Repair
• Report Date: 09/08/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 36-2025
• Device Catalogue Number: 36-2025
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 08/03/2015
• Device Age: 5 YR
• Event Location: Hospital
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/15/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/01/2010
• 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