MAUDE Adverse Event Report: SYMMETRY SURGICAL INC. CLASSIC PLUS® NEEDLE HOLDER, CRILE-WOOD, 6 IN.

Model Number	36-2000
Medical Device Problem Code	Solder Joint Fracture (2324)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Complainant alleges "during procedures the tip is breaking off inside the patient.Piece is able to be located and no injury has occurred, but the clinic has stopped using current stock of item.".
Additional Manufacturer Narrative
The device was returned and evaluated, and the complaint was confirmed.Upon inspection and subsequent discussions with the supplier regarding the nature of the observed failure, it was concluded that the root cause ws a supplier manufacturing issue.The issue was traced to inconsistencies in the soldering process of the tungsten carbide inserts, which compromised product integrity across multiple production lots.Based on the supplier's investigation, it was determined that the failure impacted production lots manufactured between late 2024 and may 2025.A deeper review revealed that a specific employee had been consistently invovled in the soldering tungsten carbide inserts across the suspected affected lots, extending beyond those initially identified in this complaint.In response to the multiple customer complaints of needle holder inserts breaking off, the supplier has been issued a scar and is requested to provide a detailed root cause analysis along with a corrective action plan to address the observed failure.Based on the supplier's recommendation, the identified suspect lots will be returned to their facility for further evaluation.This should be considered the final report.If any additional relevant information is identified, it will be submitted in a supplemental report.

• Brand Name: CLASSIC PLUS® NEEDLE HOLDER, CRILE-WOOD, 6 IN.
• Common Device Name: NEEDLE HOLDER
• Manufacturer (Section D): SYMMETRY SURGICAL INC.; 3034 owen drive; antioch TN 37013
• Manufacturer Contact: terry hall ; 3034 owen drive; antioch, TN 37013 ; 6166987100
• MDR Report Key: 23350689
• Report Number: 3007208013-2025-00058
• Device Sequence Number: 7807127
• Product Code: HXK
• UDI-Device Identifier: 00887482009628
• UDI-Public: 00887482009628
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/21/2025

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: Health Professional
• Device Model Number: 36-2000
• Device Lot Number: 31083794
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/23/2025
• Initial Report FDA Received Date: 10/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown