MAUDE Adverse Event Report: SYMMETRY SURGICAL INC. SYMMETRY® KERRISON RONGEUR, LUMBAR, 40° UP

Model Number	53-1405
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is in process of being returned for evaluation and the investigation is ongoing.Once we have additional relevant information, it will be submitted in a supplemental report.
Event or Problem Description
Complainant alleges "the kerrison rongeur#53-1405, the operator observed an unexpected gap between the upper and lower tracks of the instrument.The gap appeared while the device was being actuated and resulted in the cutting and grasping surfaces not aligning properly.This misalignment caused the instrument to feel unstable and impaired its ability to cut tissue smoothly.".
Additional Manufacturer Narrative
The device was returned for evaluation.No visual defects were observed.When activated, visually the cutting edge was smooth and aligned.Functional testing was performed using the cut test and the card stock was cut cleanly without any snags, rough cuts or hanging chads.The device passed visual and functional testing.The complaint could not be confirmed and no root cause was determined.If any additional relevant information is identified it will be submitted in a supplemental report.

• Brand Name: SYMMETRY® KERRISON RONGEUR, LUMBAR, 40° UP
• Common Device Name: KERRISON RONGEUR
• 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: 23843947
• Report Number: 3007208013-2025-00066
• Device Sequence Number: 15845946
• Product Code: HAE
• UDI-Device Identifier: 00887482022658
• UDI-Public: 00887482022658
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/13/2026

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: 53-1405
• Device Lot Number: 2392584/MAA43
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/20/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/18/2025
• Supplement Report FDA Received Date: 01/13/2026
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown