MAUDE Adverse Event Report: ARTHREX, INC. OSTEOTOME, STRAIGHT, 5.5 MM; ARTHROSCOPIC ACCESSORIES

Model Number	OSTEOTOME, STRAIGHT, 5.5 MM
Medical Device Problem Code	Dull, Blunt (2407)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/15/2023
Type of Reportable Event	Malfunction
Event or Problem Description
On the 23rd march 2023 it was advised via email that an ar-8650-09 (osteotome, straight, 5.5 mm) - (serial#(b)(6) osteotome from an ankle fusion set was deemed blunt by the surgeon.There was a case and patient involved.
Additional Manufacturer Narrative
This 3500a record is submitted to comply with an fda 483 inspectional observation issued to arthrex inc on may 5, 2023.Arthrex has reassessed the reportability decisions made on historical complaint records using revised criterion.This 3500a document is a result of the reassessment.The complaint is confirmed.One unpackaged ar-8650-09 serial/batch number (b)(6) was received for investigation.Visual evaluation found that the instrument's tip has nicks.Damage and scratches were noted on the handle.The most likely reason for the reported failure is the wear and tear damage incurred over repeated usage.

• Brand Name: OSTEOTOME, STRAIGHT, 5.5 MM
• Common Device Name: ARTHROSCOPIC ACCESSORIES
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: jared engle ; 8009337001
• MDR Report Key: 19397594
• Report Number: 1220246-2024-03918
• Device Sequence Number: 7762183
• Product Code: NBH
• UDI-Device Identifier: 00888867044234
• UDI-Public: 00888867044234
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/24/2024

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: OSTEOTOME, STRAIGHT, 5.5 MM
• Device Catalogue Number: AR-8650-09
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/13/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/15/2023
• Initial Report FDA Received Date: 05/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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