MAUDE Adverse Event Report: SYMMETRY SURGICAL INC. KERRISON RONGEUR, CERVICAL THIN FOOTPLATE

Model Number	53-1515
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#53-1515, the operator experienced difficulty actuating the instrument due to the spring mechanism becoming stuck.When the handle was compressed, the spring failed to return to its normal position, resulting in restricted or incomplete movement of the cutting shaft.As a result, the rongeur could not perform its intended cutting action consistently or efficiently.".
Additional Manufacturer Narrative
Device was returned for evaluation.The device was difficult to actuate and did not return to the open position.The device was visually inspected, and no defects were noted.The device was soaked in instrument milk and after a few moments it opened and closed easily and functioned as intended.The ifu instructs the user to lubricate the device with a water-soluble solution prior to use and between uses.The root cause was user error.If any additional relevant information is identified it will be submitted in a supplemental report.

• Brand Name: KERRISON RONGEUR, CERVICAL THIN FOOTPLATE
• 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: 23844114
• Report Number: 3007208013-2025-00067
• Device Sequence Number: 15942323
• Product Code: HAE
• UDI-Device Identifier: 00887482023112
• UDI-Public: 00887482023112
• 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: 53-1515
• Device Lot Number: 24585/2
• 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