MAUDE Adverse Event Report: ARTHREX, INC. DRIVER, T10 HEXALOBE; MANUAL INSTR, GENERAL SURGICAL

Model Number DRIVER, T10 HEXALOBE

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 09/05/2023

Event Type  malfunction  

Event Description

On 9/25/2023, an fda medwatch notification was received via email.A facility representative reported that an ar-8944dh t10 hexalobe driver tip broke off in a distal locking screw head.The tip was about 2mm, and it could not be removed from the head of the screw.This was discovered during a procedure on (b)(6) 2023.

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: DRIVER, T10 HEXALOBE
• Type of Device: MANUAL INSTR, GENERAL SURGICAL
• 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: 17995120
• MDR Text Key: 326376439
• Report Number: 1220246-2023-08333
• Device Sequence Number: 1
• Product Code: MDM
• UDI-Device Identifier: 00888867053045
• UDI-Public: 00888867053045
• 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: User Facility
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 10/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DRIVER, T10 HEXALOBE
• Device Catalogue Number: AR-8944DH
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/25/2023
• Was Device Evaluated by Manufacturer?: No
• 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