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

Model Number	C-LINE CARPAL TUNNEL SCOPE,30°,2.9X158MM
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	10/31/2019
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
It was reported during an endoscopic carpal tunnel procedure as the surgeon went to use the ar-3350-2930, c-line carpal tunnel scope the view through the lens was very blurry and the scope would not focus.A replacement scope was not brought in.The surgeon then switched from an arthroscopic to an open procedure by making a larger incision.
Additional Manufacturer Narrative
The evaluation determined that the reported event was caused by external residue on the device and visible internal debris (source unknown) at the distal tip.

• 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: 9376543
• Report Number: 1220246-2019-01441
• Device Sequence Number: 11277861
• Product Code: HRX
• UDI-Device Identifier: 00888867029583
• UDI-Public: 00888867029583
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K080560
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 03/27/2020

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: C-LINE CARPAL TUNNEL SCOPE,30°,2.9X158MM
• Device Catalogue Number: AR-3350-2930
• Device Lot Number: 10224499
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 11/08/2019
• Supplement Date Received by Manufacturer: 11/08/2019
• Initial Report FDA Received Date: 11/26/2019
• Supplement Report FDA Received Date: 03/27/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other