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

Model Number	36-2018
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	07/27/2018
Type of Reportable Event	Malfunction
Event or Problem 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
• Common Device Name: NEEDLE HOLDER
• Manufacturer (Section D): SYMMETRY SURGICAL INC; 3034 owen drive; antioch TN 37013
• MDR Report Key: 7815150
• Report Number: 3007208013-2018-00018
• Device Sequence Number: 1510862
• Product Code: HXK
• UDI-Device Identifier: 00887482009727
• UDI-Public: 00887482009727
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: No Information
• Device Model Number: 36-2018
• Device Catalogue Number: 36-2018
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/27/2018
• Initial Report FDA Received Date: 08/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1