MAUDE Adverse Event Report: ARTHREX, INC. ARTHROSCOPE, 70 DEG, 2.4 X 75MM; ARTHROSCOPE AND ACCESSORIES

Model Number	ARTHROSCOPE, 70 DEG, 2.4 X 75MM
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/24/2023
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2023, it was reported by a sales representative via sems that an ar-3350-2470 scope lens was broken.Patient was not affected.The device broke during the case, but the patient was not injured.All the pieces were retrieved.
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.
Additional Manufacturer Narrative
The complaint is confirmed.One unpackaged ar-3350-2470 serial/batch number (b)(6) was received for investigation.Visual evaluation noted that the sheath was broken.Signs of wear.The most likely cause for the reported failure is a user error.Per dfu-0073., g.Inspection, handling and maintenance.4.Do not subject the endoscope and endoscopic medical instruments to impact.Put the endoscope and endoscopic medical instruments down carefully.

• Brand Name: ARTHROSCOPE, 70 DEG, 2.4 X 75MM
• Common Device Name: ARTHROSCOPE AND 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: emily shafer ; 8009337001
• MDR Report Key: 17152561
• Report Number: 1220246-2023-06934
• Device Sequence Number: 3929135
• Product Code: HRX
• UDI-Device Identifier: 00888867029552
• UDI-Public: 00888867029552
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K080560
• 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): 07/31/2023

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: ARTHROSCOPE, 70 DEG, 2.4 X 75MM
• Device Catalogue Number: AR-3350-2470
• Device Lot Number: 1456202
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/24/2023
• Supplement Date Received by Manufacturer: 05/24/2023
• Initial Report FDA Received Date: 06/19/2023
• Supplement Report FDA Received Date: 07/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/02/2017
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown