MAUDE Adverse Event Report: ARTHREX INC. C-LINE CARPAL TUNNEL SCOPE,30°,2.9X158MM; ARTHROSCOPE

Model Number	AR-3350-2930
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	08/29/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient demographics (age at time of event, date of birth, gender, weight) were requested but not provided.No further patient information was provided at the time of this report or made available in response to follow-up communication.No additional adverse consequences have been reported from this event.This device is used for treatment.The device was requested for evaluation but was not returned therefore the complainant's event could not be verified.The cause of the event could not be determined from the information available and without device evaluation.This type of event is typically caused by damage to the rod lens system as a result of being mishandled (dropped or bent).This is the first complaint of this type for this part/lot combination.The potential causes of this event are being communicated to the event reporter.If additional relevant information is received, a follow-up report will be submitted.
Event or Problem Description
It was reported that the device has a shade inside the sight.Because of the bad sight the surgeon needed to change the technique from an endoscopic cts- surgery to a open cts-surgery.

• Brand Name: C-LINE CARPAL TUNNEL SCOPE,30°,2.9X158MM
• Common Device Name: ARTHROSCOPE
• Manufacturer (Section D): ARTHREX INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 6913255
• Report Number: 1220246-2017-00359
• Device Sequence Number: 873688
• Product Code: HRX
• UDI-Device Identifier: 00888867029583
• UDI-Public: 00888867029583
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date (Section B): 10/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: AR-3350-2930
• Device Catalogue Number: AR-3350-2930
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/13/2017
• Initial Report FDA Received Date: 10/04/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other