MAUDE Adverse Event Report: SYMMETRY SURGICAL INC. HOOK, WEARY NERVE, BLUNT, FINE, BLACK FINISH, 7 3/4 IN; SURGICAL HOOK

Model Number	38-1020
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/27/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No additional information was able to be obtained (hospital/user information, contact details, additional event narrative) based on information provided in medwatch report.Without the ability to contact the user or hospital, additional investigation is not possible.This report serves as both initial and final reports to fda.
Event or Problem Description
Complainant alleges, "the tip of the device broke off in the patient during surgery.".

• Brand Name: HOOK, WEARY NERVE, BLUNT, FINE, BLACK FINISH, 7 3/4 IN
• Common Device Name: SURGICAL HOOK
• Manufacturer (Section D): SYMMETRY SURGICAL INC.; 3034 owen dr; antioch TN 37013
• Manufacturer (Section G): SYMMETRY SURGICAL INC.; 3034 owen dr; antioch TN 37013
• Manufacturer Contact: rebecca gilbert ; 3034 owen dr; antioch, TN 37013 ; 6166987100
• MDR Report Key: 22501339
• Report Number: 3007208013-2025-00035
• Device Sequence Number: 15203708
• Product Code: GDG
• UDI-Device Identifier: 00887482012147
• UDI-Public: 00887482012147
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 07/14/2025

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: 38-1020
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/17/2025
• Initial Report FDA Received Date: 07/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Unknown
• Patient Sequence Number: 1
• Patient Age: 53 YR
• Patient Sex: Female