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

Model Number DEPTH GUIDE, MINI

Device Problems Fracture (1260); Device Slipped (1584)

Patient Problem Insufficient Information (4580)

Event Date 03/23/2021

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.

Event Description

It was reported that the top part of the depth guide fell off when the surgeon went to measure the drill hole for an implant.The tip was removed from the patient and the distal radius fracture case was completed.

Manufacturer Narrative

Complaint confirmed, the tip was found to be detached from the inner component.Evaluation revealed the weld broke but the tip itself is whole.The tip was also found to be bent.A likely cause of the event is prying/leveraging the device during use.

Manufacturer Narrative

Complaint confirmed, the tip was found to be detached from the inner component.Evaluation revealed the weld broke but the tip itself is whole.The tip was also found to be bent.A likely cause of the event is prying/leveraging the device during use.

• Brand Name: DEPTH GUIDE, MINI
• Type of Device: GAUGE, DEPTH
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 11648182
• MDR Text Key: 247538920
• Report Number: 1220246-2021-02878
• Device Sequence Number: 1
• Product Code: HTJ
• UDI-Device Identifier: 00888867007727
• UDI-Public: 00888867007727
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup,Followup
• Report Date: 07/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DEPTH GUIDE, MINI
• Device Catalogue Number: AR-13120G-2
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/23/2021
• Patient Sequence Number: 1