MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. QUICKSET TAPERED HEX SCREWDRIVER U-JOINT

Model Number 2274-63-000

Device Problems Crack (1135); Detachment of Device or Device Component (2907)

Patient Problem Insufficient Information (4580)

Event Date 05/10/2023

Event Type  malfunction  

Event Description

During the instrument inspection process of assembly, technician identified a crack and missing piece of metal from screwdriver.

• Brand Name: QUICKSET TAPERED HEX SCREWDRIVER U-JOINT
• Type of Device: SCREWDRIVER
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC.; 700 orthopaedic dr.; warsaw IN 46582
• MDR Report Key: 16983449
• MDR Text Key: 315759993
• Report Number: 16983449
• Device Sequence Number: 1
• Product Code: HXX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 05/12/2023

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 Model Number: 2274-63-000
• Device Catalogue Number: 227463000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/12/2023
• Event Location: Hospital
• Date Report to Manufacturer: 05/23/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/23/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1