MAUDE Adverse Event Report: ARTHREX, INC. DISSECTOR, SJ 3.0MM X 7CM; SAW BLADE

Model Number	DISSECTOR, SJ 3.0MM X 7CM
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/21/2022
Type of Reportable Event	Malfunction
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.Complaint is confirmed.Three unpackaged, and one packaged ar-7300ds dissector, sj, 3.0 mm x 7 cm serial/batch number 14962578 were received for investigation.No functional testing was performed because the damaged on the three reported devices.Visual evaluation found that device #1 outer tube is burn at the tip.Device #2, inner tube is weld to the outer tube avoid the inner tube move freely.Device #3 have heavy scratches lines around the outside dimeter of the inner tube and inside the outer tube.The most likely cause for the reported failure is misuse/abnormal use: since the device became red at the tip and produced smoke, but no burn was reported, it follows by logical reasoning that the device was activated outside the surgical site, which precludes the usage of irrigation.Activating the device outside the surgical site without irrigation (dry environment) characterizes misuse and may cause overheating.
Event or Problem Description
On (b)(6) 2022 it was reported by a sales representative via email that (2) ar-7300ds dissector had issues during use.The first dissector, the blade would not spin.The second dissector turned red at the tip and started smoking.It seems as if the inner and outer blades were fused together.Additional information received on 12/27/2022: this was discovered during an ankle scope procedure on (b)(6) 2022.Nothing broke inside the patient.

• Brand Name: DISSECTOR, SJ 3.0MM X 7CM
• Common Device Name: SAW BLADE
• 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: 19488990
• Report Number: 1220246-2024-05177
• Device Sequence Number: 7024964
• Product Code: GFA
• UDI-Device Identifier: 00888867041943
• UDI-Public: 00888867041943
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/07/2024

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: DISSECTOR, SJ 3.0MM X 7CM
• Device Catalogue Number: AR-7300DS
• Device Lot Number: 14962578
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/22/2022
• Initial Report FDA Received Date: 06/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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