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

Device Problem Material Opacification (1426)

Patient Problem Insufficient Information (4580)

Event Date 08/11/2021

Event Type  Injury  

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.

Event Description

It was reported on (b)(6) 2021 during a procedure, the arthroscope, ar-3350-2930, was found to be cloudy.A backup scope was not available and the surgeon converted to an open procedure to complete the case.No further information provided.

• Brand Name: C-LINE CARPAL TUNNEL SCOPE,30,2.9X158MM
• Type of Device: ARTHROSCOPE
• 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: vik bajnath ; 8009337001
• MDR Report Key: 12434700
• MDR Text Key: 270164343
• Report Number: 1220246-2021-03608
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 00888867029583
• UDI-Public: 00888867029583
• 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
• Report Date: 09/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Date Manufacturer Received: 08/17/2021
• Is the Device Single Use?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other