MAUDE Adverse Event Report: SYMMETRY SURGICAL INC. RAPIDCLEAN® KERRISON RONGEUR, MICRO

Model Number	58-4230J-BD
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Complainant alleges "the 4mm kerrisons (58-4230j-bd) have been the biggest issue over the past few months.Lubricant is now at every station in spd, but we are still facing the same issues with the screws backing out or coming out completely.".
Additional Manufacturer Narrative
The device is in process of being returned for evaluation, and the investigation is ongoing.Once additional relevant information is identified, it will be submitted in a supplemental report.
Additional Manufacturer Narrative
The device was not returned for evaluation.The complaint could not be confirmed and the root cause could not be determined.If any additional relevant information is identified it will be submitted in a supplemental report.

• Brand Name: RAPIDCLEAN® KERRISON RONGEUR, MICRO
• 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: 23922043
• Report Number: 3007208013-2025-00072
• Device Sequence Number: 8909714
• Product Code: HTX
• UDI-Device Identifier: 00887482102732
• UDI-Public: 00887482102732
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/13/2026

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: 58-4230J-BD
• Device Lot Number: 82404345, 82400774
• 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: 12/04/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/30/2025
• Supplement Report FDA Received Date: 02/13/2026
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown