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

Device Problem Material Fragmentation (1261)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/24/2023

Event Type  malfunction  

Event 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.

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.

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
• Type of Device: 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
• MDR Text Key: 317671311
• Report Number: 1220246-2023-06934
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 00888867029552
• UDI-Public: 00888867029552
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K080560
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 07/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 05/24/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/02/2017
• Is the Device Single Use?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1