MAUDE Adverse Event Report: ARTHREX, INC. SS OPEN CNULA,BLNT,DETACHABLE HNDL; ARTHROSCOPIC ACCESSORIES

Model Number	SS OPEN CNULA,BLNT,DETACHABLE HNDL
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/05/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported during a hip scope procedure the surgeon was using the ar-6507-03 and ar-6507-04 to get into joint, and both devices bent.See source data and images attached.
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 confirmed, the device was found to be severely bent.A likely cause of the event is user-applied mechanical forces.

• Brand Name: SS OPEN CNULA,BLNT,DETACHABLE HNDL
• 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: 19082126
• Report Number: 1220246-2024-01961
• Device Sequence Number: 20740319
• Product Code: NBH
• UDI-Device Identifier: 00888867039582
• UDI-Public: 00888867039582
• Combination Product (Y/N): N
• Initial Reporter State: NV
• 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
• Report Date (Section B): 04/10/2024

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: SS OPEN CNULA,BLNT,DETACHABLE HNDL
• Device Catalogue Number: AR-6507-04
• Device Lot Number: 0071832
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/05/2021
• Initial Report FDA Received Date: 04/10/2024
• 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