MAUDE Adverse Event Report: ARTHREX, INC. SHEATH BODY, TAP/FEN, HF/4MM SCP STH SYS; ARTHROSCOPE AND ACCESSORIES

Model Number SHEATH BODY, TAP/FEN, HF/4MM SCP STH SYS

Device Problem Device Damaged Prior to Use (2284)

Patient Problem Insufficient Information (4580)

Event Date 11/16/2023

Event Type  malfunction  

Event Description

On 11/16/2023, it was reported by a facility representative via (b)(4) that an ar-3371-4000 sheath body was damaged in an unspecified state with no further information provided.It is stated that it is unknown if there was case involvement.

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.

• Brand Name: SHEATH BODY, TAP/FEN, HF/4MM SCP STH SYS
• 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: 18340868
• MDR Text Key: 331056341
• Report Number: 1220246-2023-09448
• Device Sequence Number: 1
• Product Code: NBH
• UDI-Device Identifier: 00888867030145
• UDI-Public: 00888867030145
• 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: Health Professional,User Facility
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 12/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SHEATH BODY, TAP/FEN, HF/4MM SCP STH SYS
• Device Catalogue Number: AR-3371-4000
• Device Lot Number: 1634616
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 11/16/2023
• Initial Date FDA Received: 12/15/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/30/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1