MAUDE Adverse Event Report: ARTHREX, INC. DISSECTOR, 3.0MM X 7CM; POWERED SURG ORTHOPEDIC INSTR

Model Number	DISSECTOR, 3.0MM X 7CM
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/05/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.
Event or Problem Description
On 5th january 2024, it was reported by an arthrex employee via email that an ar-9300ds, dissector, small hub, 3.0 mm x 7 cm, had a manufacturing problem.This was detected during an arthroscopic ankle and ligament reconstruction procedure on (b)(4) 2024.The procedure was completed successfully as the surgeon decided to use sabre.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.Based on the information provided, which may include the device (if available and returned), pictures, videos, event descriptions, and any additional information from the field, arthrex concluded the cause of the reported failure.The cause of the reported failure is an internal manufacturing process issue.Per qsd-000100294 rev 21, standard inspection procedure for shaver, burrs, saw blades, power picks, rasp and handpiece components, visual inspection item 7: must be free of burrs, cracks, obvious scratches, nicks, gouges.Ncr-28975 was initiated to further investigate this issue.The complaint is confirmed based on the customer's attached pictures that display the outer tube window of an ar-9300ds dissector, small hub, 3.0 mm x 7 cm damaged.

• Brand Name: DISSECTOR, 3.0MM X 7CM
• Common Device Name: POWERED SURG ORTHOPEDIC INSTR
• 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: emily shafer ; 8009337001
• MDR Report Key: 18574318
• Report Number: 1220246-2024-00511
• Device Sequence Number: 15434573
• Product Code: GFA
• UDI-Device Identifier: 00888867211834
• UDI-Public: 00888867211834
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 03/14/2025

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: DISSECTOR, 3.0MM X 7CM
• Device Catalogue Number: AR-9300DS
• Device Lot Number: 15137961
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 03/05/2025
• Initial Report FDA Received Date: 01/24/2024
• Supplement Report FDA Received Date: 03/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/06/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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
• Patient Sex: Unknown