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

Model Number 36-2018

Device Problems Break (1069); Material Fragmentation (1261)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 07/27/2018

Event Type  malfunction  

Event Description

A needle holder insert broke during a surgical procedure into several pieces.The breakage was not noticed until the instrument made it to central processing.An x-ray was conducted on the patient and determined that pieces of the insert were left in the patient.The facility determined they did not need to re-open the patient to retrieve the pieces at this time.The needle holder had been repaired by a third-party repair facility.

• Brand Name: CLASSIC PLUS
• Type of Device: NEEDLE HOLDER
• Manufacturer (Section D): SYMMETRY SURGICAL INC; 3034 owen drive; antioch TN 37013
• Manufacturer (Section G): SYMMETRY SURGICAL INC; 3034 owen drive; antioch TN 37013
• Manufacturer Contact: victoria rogers ; 3034 owen drive; antioch, TN 37013 ; 8002513000
• MDR Report Key: 7815150
• MDR Text Key: 118405349
• Report Number: 3007208013-2018-00018
• Device Sequence Number: 1
• Product Code: HXK
• UDI-Device Identifier: 00887482009727
• UDI-Public: 00887482009727
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/24/2018

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: 36-2018
• Device Catalogue Number: 36-2018
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/27/2018
• Initial Date FDA Received: 08/24/2018
• Was Device Evaluated by Manufacturer?: No
• 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