MAUDE Adverse Event Report: ARTHREX, INC. C-LINE ENDOSCOPIC SOFT TISS REL INST; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number C-LINE ENDOSCOPIC SOFT TISS REL INST

Device Problem Use of Device Problem (1670)

Patient Problems Nerve Damage (1979); Pain (1994); Numbness (2415)

Event Date 06/03/2022

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

On (b)(6) 2022, it was reported by a sales representative via email that on (b)(6) 2022, patient underwent an endoscopic carpal tunnel release procedure, which was completed successfully.On (b)(6) 2022, surgeon became aware that the patient could not feel on the radial side of the index finger.Surgeon concluded that while using an ar-8850 centerline endoscopic carpal tunnel release instrument, too much palmer cutaneous branch of the median nerve was cut.No further issues has been reported at this time.Additional information received on (b)(6) 2022: per sales representative, the surgeon would like to proceed by going back in and stitching the nerve back together in hope patient would feel again.However, the patient has not agreed to this yet and would like wait and see if sensation is regained on its own.Additional information received on (b)(6) 2022: sales representative has reached out to the surgeon who has confirmed that the patient has completely opted out of having a revision surgery to stitch the nerves back together and will live with the lack of sensation in that finger.Surgeon also stated that patient was suffering from extensive numbness throughout the radial half of the hand along with pain prior to procedure.Post operative, patient pain went away and reported to have less numbness overall.

• Brand Name: C-LINE ENDOSCOPIC SOFT TISS REL INST
• Type of Device: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• 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: 14842814
• MDR Text Key: 295110636
• Report Number: 1220246-2022-05134
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 00888867048546
• UDI-Public: 00888867048546
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• 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: 06/27/2022

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
• Device Model Number: C-LINE ENDOSCOPIC SOFT TISS REL INST
• Device Catalogue Number: AR-8850
• Device Lot Number: 2011118569
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/08/2022
• Initial Date FDA Received: 06/28/2022
• Date Device Manufactured: 03/01/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other