MAUDE Adverse Event Report: SYMMETRY SURGICAL INC. SYMMETRY MAYO CLASSIC®; HOLDER, NEEDLE; ORTHOPEDIC

Model Number	36-2017
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/19/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
A needle driver was found in sterile processing to be missing a layer of the inner tip.The instrument was pulled from service.The quality assurance team connected and confirmed the results of the pathology specimen, a 1 mm x ~2 mm metallic flake of a textured gripping surface, to the sequestered needle driver.This metal fleck was in the patient in the wound, found on routine post operative xray, likely broke off during suturing/closing the wound.The needle driver/holder was still functional, and the broken off fleck was so small, it was not identified at time of use on the patient.The patient did return to the or for removal of the foreign object.

• Brand Name: SYMMETRY MAYO CLASSIC®
• Common Device Name: HOLDER, NEEDLE; ORTHOPEDIC
• Manufacturer (Section D): SYMMETRY SURGICAL INC.; 3034 owen drive; antioch TN 37013
• MDR Report Key: 22505785
• Report Number: 22505785
• Device Sequence Number: 12959016
• Product Code: HXK
• UDI-Device Identifier: 00887482009710
• UDI-Public: (01)00887482009710(10)31081195
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/25/2025
• Report Date (Section F): 06/25/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 36-2017
• Device Catalogue Number: 36-2017
• Device Lot Number: 31081195
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2025
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 07/15/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/15/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 67 YR
• Patient Sex: Female
• Date Report Sent to FDA: 06/25/2025