MAUDE Adverse Event Report: ARTHREX, INC. DISSECTOR, CURVED 4.0MM X 13CM; SAW BLADE

Model Number	DISSECTOR, CURVED 4.0MM X 13CM
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/13/2023
Type of Reportable Event	Malfunction
Event or Problem Description
On 10/13/2023, it was reported by a sales representative via sems-06056928 that an ar-8400cds dissector was pushed down and the teeth were bent in, it would not rotate when trying to engage.This occurred during a case with no patient effect reported.
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
Additional information: it was reported by a sales representative that this event occurred during a meniscus repair on (b)(6) 2023 where a 4.0 torpedo was used to complete the case.
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 that the most likely cause.The most likely cause of the reported failure is misuse of the product caused by the surgeon using excessive force and bending the device.If the device is bent during use, the device may fail to operate as intended.The complaint allegation was not confirmed.The device was not received for evaluation, and no evidence of the failure was provided.

• Brand Name: DISSECTOR, CURVED 4.0MM X 13CM
• 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: emily shafer ; 8009337001
• MDR Report Key: 18066788
• Report Number: 1220246-2023-08541
• Device Sequence Number: 18096557
• Product Code: GFA
• UDI-Device Identifier: 00888867043497
• UDI-Public: 00888867043497
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 02/28/2025

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, CURVED 4.0MM X 13CM
• Device Catalogue Number: AR-8400CDS
• Device Lot Number: 15121203
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/13/2023
• Supplement Date Received by Manufacturer: 02/18/2025
• Initial Report FDA Received Date: 11/03/2023
• Supplement Report FDA Received Date: 02/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/27/2023
• 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