MAUDE Adverse Event Report: SCANLAN INTERNATIONAL, INC. SCANLAN DENNIS RIB CUTTER

Model Number	9909-902
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/17/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The rib cutter in question was not returned for further analysis.Review of the design, manufacturing batch record, and technical documentation found no non-conformities.Inspection of product from the current production lot indicate that the rib cutters meet specifications and perform as intended.Unable to draw a conclusion from the information available.
Event or Problem Description
The instrument did not cut the ribs but crushed them instead.This caused an estimated additional hour during the surgery.The procedure was completed successfully and the patient did have a good outcome.This issue occured with the first use of the instrument.As reported.

• Brand Name: SCANLAN DENNIS RIB CUTTER
• Common Device Name: RIB CUTTER
• Manufacturer (Section D): SCANLAN INTERNATIONAL, INC.; one scanlan plaza; saint paul 55107 1608
• Manufacturer (Section G): SCANLAN INTERNATIONAL; one scanlan plaza; saint paul MN 55107 1629
• Manufacturer Contact: mark watson ; one scanlan plaza; saint paul 55107-1608 ; 6517285759
• MDR Report Key: 20925676
• Report Number: 2126670-2024-00007
• Device Sequence Number: 14716427
• Product Code: HTX
• UDI-Device Identifier: 00846159033694
• UDI-Public: 00846159033694
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: 505
• Type of Report: Initial
• Report Date (Section B): 11/15/2024

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: 9909-902
• Device Catalogue Number: 9909-902
• Device Lot Number: BD6B1
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/04/2024
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Prefer Not To Disclose