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

Model Number GUIDE PIN DEPTH GAUGE

Device Problem Material Fragmentation (1261)

Patient Problem Insufficient Information (4580)

Event Date 08/22/2023

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 08/22/2023, it was reported by a sales representative via sems that an ar-9616-dg guide pin depth gauge was going through spd after use, and metal shavings were found in the cannulation.This was discovered after use in a reverse total shoulder arthroplasty case on (b)(6) 2023.

• Brand Name: GUIDE PIN DEPTH GAUGE
• Type of Device: DEPTH GAUGE
• 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: 17755561
• MDR Text Key: 323502505
• Report Number: 1220246-2023-07913
• Device Sequence Number: 1
• Product Code: HTJ
• 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: 09/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GUIDE PIN DEPTH GAUGE
• Device Catalogue Number: AR-9616-DG
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/22/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1