MAUDE Adverse Event Report: SYMMETRY SURGICAL INC SYMMETRY CLASSIC PLUS; STERNAL NEEDLE HOLDER

Catalog Number 36-2025

Device Problems Entrapment of Device (1212); Device Dislodged or Dislocated (2923)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 08/01/2019

Event Type  malfunction  

Manufacturer Narrative

There has been a total of (b)(6) sold of this product code since 2013 with 3 other complaints recorded for similar occurrences.This equates to a (b)(6) complaint rate which is categorized as low.The product has not been received for evaluation.A follow-up report will be submitted once new information is acquired.

Event Description

At the conclusion of the procedure, when placing the sternal wires, the "insert" from the sternal wire needle driver became dislodged from the instrument and was retained in the patient's chest.Per x-ray, the patient underwent an additional surgery to partially reopen the chest wall to revolve the piece.As a result, the patient remained in the hospital for two additional inpatient admission days.

Manufacturer Narrative

Upon evaluating the returned instrument, it was confirmed that it had significant damage on the jaws and around the inserts.The lot number on the instrument traced back to an order from the customer in dec 2016.With this information it can be determined that the instrument has been in use for approximately 3 years.There were no repair codes noted on the device, and the user facility did not believe the inserts had ever been repaired or replaced.It can be determined that the damaged occurred due to wear and tear over 3 years of use.Based on the root cause and the complaint probability no further actions required.This can be seen as the final report, if additional information is obtained that alleges any other patient involvement or need for corrective actions, a follow up report will be submitted.

• Brand Name: SYMMETRY CLASSIC PLUS
• Type of Device: STERNAL NEEDLE HOLDER
• Manufacturer (Section D): SYMMETRY SURGICAL INC; 3034 owen drive; antioch TN 37013
• MDR Report Key: 9511537
• MDR Text Key: 188933247
• Report Number: 3007208013-2019-00039
• Device Sequence Number: 1
• Product Code: HXK
• UDI-Device Identifier: 00887482009772
• UDI-Public: 00887482009772
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 12/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 36-2025
• Device Lot Number: 31018167
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/02/2020
• Date Manufacturer Received: 01/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention