MAUDE Adverse Event Report: ARTHREX, INC. GUIDE WIRE, DOUBLE ENDED TROCAR, .045"; ACCESSORIES, ARTHROSCOPIC

Model Number GUIDE WIRE, DOUBLE ENDED TROCAR, .045"

Device Problems Break (1069); Entrapment of Device (1212)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 12/16/2021

Event Type  malfunction  

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) 2021 it was reported by a sales representative via the phone that the tip of a ar-8737-41kd broke off inside the patient.The piece was not retrieved.This was discovered during use in a mpfl procedure on (b)(6) 2021.

• Brand Name: GUIDE WIRE, DOUBLE ENDED TROCAR, .045"
• Type of Device: ACCESSORIES, ARTHROSCOPIC
• 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: 13225467
• MDR Text Key: 287179941
• Report Number: 1220246-2022-04258
• Device Sequence Number: 1
• Product Code: NBH
• UDI-Device Identifier: 00888867189713
• UDI-Public: 00888867189713
• 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: 01/11/2022

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: GUIDE WIRE, DOUBLE ENDED TROCAR, .045"
• Device Catalogue Number: AR-8737-41KD
• Device Lot Number: 0022100593
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/21/2021
• Initial Date FDA Received: 01/11/2022
• Date Device Manufactured: 02/17/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1