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	Material Fragmentation (1261)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/20/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a surgery the use of the shaverblade resulted in metal debris.There was no harm for patient, operator or third party reported.No further information received.Update dw 06-sep-2024: further information was provided that he case took place on august 20th with an ar-7300ds - lot 15205016.This event occurred during a wrist arthroscopy.The fragments were found inside the patient's joint and could be partially removed.The surgery was completed successful.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6 the complaint allegation is confirmed for the unpackaged device.One unpackaged and five packaged ar-7300ds dissectors batch number: 15205016 were received for investigation.Upon visual inspection of the unpackaged device, it was noted that the device had nicks around the edges of the outer tube windows.After removing the outer tube, the inner tube was inspected, and it was noted that there were scratches and marks on the tip of the inner tube.Striations were also noted within the outer tube's inner surface.Refer to investigation photos.Visual evaluation of the five packaged ar-7300ds dissectors returned did not notice any issues.Functional testing for the packaged devices was performed and the metal particulates produced were measured.It was found that the metal particulates produced were less than 18,000, the specification stated in the dtm.These results indicate no problem with 5 unpackaged devices of the same batch.Refer to attachments.The most likely cause for the reported failure can be attributed to user error.Per dfu-0215-7 at revision 0.Section f.Precautions.7.Excessive "side-loading" on the device during use does not improve cutting performance and, in extreme cases, will cause irreversible damage to the device.

• 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: 20192949
• Report Number: 1220246-2024-07524
• Device Sequence Number: 7526191
• Product Code: GFA
• UDI-Device Identifier: 00888867041943
• UDI-Public: 00888867041943
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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): 02/05/2025

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, SJ 3.0MM X 7CM
• Device Catalogue Number: AR-7300DS
• Device Lot Number: 15205016
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/22/2024
• Supplement Date Received by Manufacturer: 01/09/2025
• Initial Report FDA Received Date: 09/11/2024
• Supplement Report FDA Received Date: 02/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/09/2024
• 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