MAUDE Adverse Event Report: ARTHREX, INC. DEPTH GUIDE, MINI; GAUGE, DEPTH

Model Number DEPTH GUIDE, MINI

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 07/05/2022

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) 2022 , it was reported by a sales representative via email that an ar-13120g-2 depth gauge broke during regular usage.This was discovered during an unspecified procedure on (b)(6) 2022.Additional information requested.

Manufacturer Narrative

Visual inspection found the pin of the device is broken off and returned with device.Complaint was confirmed.

• Brand Name: DEPTH GUIDE, MINI
• Type of Device: GAUGE, DEPTH
• 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: 15093436
• MDR Text Key: 304559099
• Report Number: 1220246-2022-05287
• Device Sequence Number: 1
• Product Code: HTJ
• UDI-Device Identifier: 00888867007727
• UDI-Public: 00888867007727
• 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,Followup
• Report Date: 10/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: DEPTH GUIDE, MINI
• Device Catalogue Number: AR-13120G-2
• Device Lot Number: 01154400
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/05/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1